Trial Outcomes & Findings for Sleep Apnea Intervention for Cardiovascular Disease Reduction (NCT NCT01261390)

Results Overview

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

169 participants

Primary outcome timeframe

Mean of 6- and 12-months

Results posted on

2017-05-30

Participant Flow

Initial recruitment was limited to patients with sleep apnea identified through clinical sleep programs of Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Recruitment later expanded to include patients presenting to cardiology and diabetes clinics. Recruitment began on April 2011 and ended on June 2013.

Patients with no sleep study were provided a portable sleep monitor to measure the severity (if any) of obstructive sleep apnea (OSA). If tests shows moderate to severe OSA, patients were asked to wear a positive airway pressure (PAP) mask with no pressure for 2 weeks. Those with proven adherence during this time were scheduled for a baseline visit

Participant milestones

Participant milestones
Measure	Conservative Medical Therapy (CMT) All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.	Sham PAP (Sham) In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.	Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Overall Study STARTED	44	42	42	41
Overall Study 6-Month Visit	37	34	34	32
Overall Study 12-Month Visit	23	21	19	19
Overall Study COMPLETED	37	33	35	33
Overall Study NOT COMPLETED	7	9	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Conservative Medical Therapy (CMT) All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.	Sham PAP (Sham) In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.	Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Overall Study Significant Concurrent Illness	1	0	1	0
Overall Study Dissatisfaction with Treatment	2	1	1	2
Overall Study Relocation	0	1	0	0
Overall Study Loss of Interest in the Study	3	1	0	0
Overall Study Lost to Follow-up	1	6	5	6

Baseline Characteristics

We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conservative Medical Therapy (CMT) n=44 Participants All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.	Sham PAP (Sham) n=42 Participants In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.	Active PAP With RT Support (Active-Beh) n=42 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=41 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.	Total n=169 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 6.3 • n=44 Participants	63.0 years STANDARD_DEVIATION 7.5 • n=42 Participants	63.7 years STANDARD_DEVIATION 7.3 • n=42 Participants	63.6 years STANDARD_DEVIATION 8.2 • n=41 Participants	63.6 years STANDARD_DEVIATION 7.3 • n=169 Participants
Sex: Female, Male Female	12 Participants n=44 Participants	19 Participants n=42 Participants	14 Participants n=42 Participants	14 Participants n=41 Participants	59 Participants n=169 Participants
Sex: Female, Male Male	32 Participants n=44 Participants	23 Participants n=42 Participants	28 Participants n=42 Participants	27 Participants n=41 Participants	110 Participants n=169 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=44 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=41 Participants	6 Participants n=169 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=44 Participants	41 Participants n=42 Participants	41 Participants n=42 Participants	38 Participants n=41 Participants	163 Participants n=169 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=44 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=41 Participants	0 Participants n=169 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=44 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=41 Participants	0 Participants n=169 Participants
Race (NIH/OMB) Asian	1 Participants n=44 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=41 Participants	3 Participants n=169 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=44 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=41 Participants	0 Participants n=169 Participants
Race (NIH/OMB) Black or African American	2 Participants n=44 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=41 Participants	11 Participants n=169 Participants
Race (NIH/OMB) White	41 Participants n=44 Participants	36 Participants n=42 Participants	37 Participants n=42 Participants	37 Participants n=41 Participants	151 Participants n=169 Participants
Race (NIH/OMB) More than one race	0 Participants n=44 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=41 Participants	0 Participants n=169 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=44 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=41 Participants	4 Participants n=169 Participants
Cardiovascular Disease (CVD) Status CVD Risk Factors	20 participants n=44 Participants	17 participants n=42 Participants	17 participants n=42 Participants	18 participants n=41 Participants	72 participants n=169 Participants
Cardiovascular Disease (CVD) Status Established CVD	24 participants n=44 Participants	25 participants n=42 Participants	25 participants n=42 Participants	23 participants n=41 Participants	97 participants n=169 Participants
Diagnostic Type Full-Night	41 participants n=44 Participants	39 participants n=42 Participants	39 participants n=42 Participants	38 participants n=41 Participants	157 participants n=169 Participants
Diagnostic Type Split-Night	3 participants n=44 Participants	3 participants n=42 Participants	3 participants n=42 Participants	3 participants n=41 Participants	12 participants n=169 Participants
BMI	32.4 kg/m^2 STANDARD_DEVIATION 7.2 • n=44 Participants	32.1 kg/m^2 STANDARD_DEVIATION 5.7 • n=42 Participants	30.6 kg/m^2 STANDARD_DEVIATION 4.5 • n=42 Participants	31.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=41 Participants	31.7 kg/m^2 STANDARD_DEVIATION 5.9 • n=169 Participants
Waist Circumference	110.2 cm STANDARD_DEVIATION 16.1 • n=44 Participants	112.6 cm STANDARD_DEVIATION 14.5 • n=42 Participants	108.3 cm STANDARD_DEVIATION 12.2 • n=42 Participants	110.6 cm STANDARD_DEVIATION 13.3 • n=41 Participants	110.4 cm STANDARD_DEVIATION 14.1 • n=169 Participants
AHI	33.9 respiratory events per hour STANDARD_DEVIATION 21.8 • n=44 Participants	31.5 respiratory events per hour STANDARD_DEVIATION 20.0 • n=42 Participants	27.6 respiratory events per hour STANDARD_DEVIATION 12.5 • n=42 Participants	26.8 respiratory events per hour STANDARD_DEVIATION 12.4 • n=41 Participants	30.0 respiratory events per hour STANDARD_DEVIATION 17.4 • n=169 Participants
Baseline Resting Blood Pressure Data by Arm Average Resting Systolic	125.1 mmHg STANDARD_DEVIATION 15.3 • n=44 Participants	123.6 mmHg STANDARD_DEVIATION 18.1 • n=42 Participants	124.8 mmHg STANDARD_DEVIATION 19.5 • n=42 Participants	127.5 mmHg STANDARD_DEVIATION 16.2 • n=41 Participants	125.2 mmHg STANDARD_DEVIATION 17.2 • n=169 Participants
Baseline Resting Blood Pressure Data by Arm Average Resting Diastolic	70.1 mmHg STANDARD_DEVIATION 8.6 • n=44 Participants	68.6 mmHg STANDARD_DEVIATION 8.5 • n=42 Participants	71.2 mmHg STANDARD_DEVIATION 10.6 • n=42 Participants	71.3 mmHg STANDARD_DEVIATION 8.9 • n=41 Participants	70.3 mmHg STANDARD_DEVIATION 9.2 • n=169 Participants
Baseline 24-Hour Blood Pressure Data by Arm 24-hour Systolic Blood Pressure	125.4 mmHg STANDARD_DEVIATION 14.3 • n=40 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	128.1 mmHg STANDARD_DEVIATION 14.4 • n=40 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	121.3 mmHg STANDARD_DEVIATION 10.4 • n=41 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	121.8 mmHg STANDARD_DEVIATION 11.0 • n=40 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	124.1 mmHg STANDARD_DEVIATION 12.8 • n=161 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.
Baseline 24-Hour Blood Pressure Data by Arm Sleep Mean Arterial Pressure	83.3 mmHg STANDARD_DEVIATION 12.4 • n=44 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	84.7 mmHg STANDARD_DEVIATION 11.2 • n=42 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	81.1 mmHg STANDARD_DEVIATION 8.0 • n=42 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	81.5 mmHg STANDARD_DEVIATION 10.2 • n=41 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	82.7 mmHg STANDARD_DEVIATION 10.6 • n=169 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.
Baseline 24-Hour Blood Pressure Data by Arm 24-hour Mean Arterial Pressure	90.7 mmHg STANDARD_DEVIATION 9.8 • n=44 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	92.0 mmHg STANDARD_DEVIATION 8.7 • n=42 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	89.3 mmHg STANDARD_DEVIATION 6.5 • n=42 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	89.2 mmHg STANDARD_DEVIATION 7.4 • n=41 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.	90.3 mmHg STANDARD_DEVIATION 8.2 • n=169 Participants • We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit.
Baseline Laboratory Measures by Arm - Triglyceride and HDL Triglyceride	130.3 mg/dL STANDARD_DEVIATION 85.8 • n=44 Participants	125.8 mg/dL STANDARD_DEVIATION 61.6 • n=42 Participants	108.3 mg/dL STANDARD_DEVIATION 57.1 • n=42 Participants	143.8 mg/dL STANDARD_DEVIATION 81.8 • n=41 Participants	127.0 mg/dL STANDARD_DEVIATION 73.2 • n=169 Participants
Baseline Laboratory Measures by Arm - Triglyceride and HDL HDL	49.1 mg/dL STANDARD_DEVIATION 14.9 • n=44 Participants	50.0 mg/dL STANDARD_DEVIATION 12.2 • n=42 Participants	55.7 mg/dL STANDARD_DEVIATION 16.9 • n=42 Participants	47.4 mg/dL STANDARD_DEVIATION 12.9 • n=41 Participants	50.5 mg/dL STANDARD_DEVIATION 14.6 • n=169 Participants
Baseline Laboratory Measures by Arm - CRP	3.9 mg/L STANDARD_DEVIATION 9.0 • n=44 Participants • We were not able to collect C-Reactive Protein (CRP) values from all participants that completed a baseline visit.	5.6 mg/L STANDARD_DEVIATION 17.6 • n=42 Participants • We were not able to collect C-Reactive Protein (CRP) values from all participants that completed a baseline visit.	4.5 mg/L STANDARD_DEVIATION 10.4 • n=42 Participants • We were not able to collect C-Reactive Protein (CRP) values from all participants that completed a baseline visit.	3.0 mg/L STANDARD_DEVIATION 2.7 • n=40 Participants • We were not able to collect C-Reactive Protein (CRP) values from all participants that completed a baseline visit.	4.3 mg/L STANDARD_DEVIATION 11.2 • n=168 Participants • We were not able to collect C-Reactive Protein (CRP) values from all participants that completed a baseline visit.
Baseline Echocardiogram Measures by Arm - Pulse Wave Velocity	9.6 m/s STANDARD_DEVIATION 2.1 • n=34 Participants • We were not able to collect pulse wave velocity values from all participants that completed a baseline visit.	9.7 m/s STANDARD_DEVIATION 2.4 • n=34 Participants • We were not able to collect pulse wave velocity values from all participants that completed a baseline visit.	8.6 m/s STANDARD_DEVIATION 1.8 • n=39 Participants • We were not able to collect pulse wave velocity values from all participants that completed a baseline visit.	9.4 m/s STANDARD_DEVIATION 1.8 • n=38 Participants • We were not able to collect pulse wave velocity values from all participants that completed a baseline visit.	9.3 m/s STANDARD_DEVIATION 2.1 • n=145 Participants • We were not able to collect pulse wave velocity values from all participants that completed a baseline visit.
Baseline Echocardiogram Measures by Arm - Augmentation Index	30.6 percent of central pulse pressure STANDARD_DEVIATION 9.6 • n=41 Participants • We were not able to collect augmentation index values from all participants that completed a baseline visit.	30.2 percent of central pulse pressure STANDARD_DEVIATION 9.7 • n=38 Participants • We were not able to collect augmentation index values from all participants that completed a baseline visit.	29.8 percent of central pulse pressure STANDARD_DEVIATION 9.3 • n=41 Participants • We were not able to collect augmentation index values from all participants that completed a baseline visit.	29.8 percent of central pulse pressure STANDARD_DEVIATION 8.7 • n=39 Participants • We were not able to collect augmentation index values from all participants that completed a baseline visit.	30.1 percent of central pulse pressure STANDARD_DEVIATION 9.3 • n=159 Participants • We were not able to collect augmentation index values from all participants that completed a baseline visit.
Baseline Echocardiogram Measures by Arm - Ejection Fraction	60.2 percent ejection fraction STANDARD_DEVIATION 4.1 • n=38 Participants • We were not able to collect ejection fraction values from all participants that completed a baseline visit.	60.9 percent ejection fraction STANDARD_DEVIATION 2.7 • n=37 Participants • We were not able to collect ejection fraction values from all participants that completed a baseline visit.	60.8 percent ejection fraction STANDARD_DEVIATION 6.6 • n=38 Participants • We were not able to collect ejection fraction values from all participants that completed a baseline visit.	59.9 percent ejection fraction STANDARD_DEVIATION 4.6 • n=37 Participants • We were not able to collect ejection fraction values from all participants that completed a baseline visit.	60.5 percent ejection fraction STANDARD_DEVIATION 4.7 • n=150 Participants • We were not able to collect ejection fraction values from all participants that completed a baseline visit.
Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) SF-36 Vitality Subscale	49.6 units on a scale STANDARD_DEVIATION 10.1 • n=43 Participants • We were not able to collect all values from all participants that completed a baseline visit.	48.0 units on a scale STANDARD_DEVIATION 9.7 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	49.0 units on a scale STANDARD_DEVIATION 10.4 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	48.7 units on a scale STANDARD_DEVIATION 9.6 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	48.9 units on a scale STANDARD_DEVIATION 9.9 • n=163 Participants • We were not able to collect all values from all participants that completed a baseline visit.
Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) SF-36 Emotional Subscale	47.9 units on a scale STANDARD_DEVIATION 10.7 • n=43 Participants • We were not able to collect all values from all participants that completed a baseline visit.	44.9 units on a scale STANDARD_DEVIATION 12.3 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	48.4 units on a scale STANDARD_DEVIATION 11.1 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	45.5 units on a scale STANDARD_DEVIATION 12.3 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	46.7 units on a scale STANDARD_DEVIATION 11.6 • n=163 Participants • We were not able to collect all values from all participants that completed a baseline visit.
Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) SF-36 Physical Subscale	44.1 units on a scale STANDARD_DEVIATION 10.9 • n=43 Participants • We were not able to collect all values from all participants that completed a baseline visit.	44.3 units on a scale STANDARD_DEVIATION 10.7 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	47.1 units on a scale STANDARD_DEVIATION 10.0 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	44.4 units on a scale STANDARD_DEVIATION 10.9 • n=41 Participants • We were not able to collect all values from all participants that completed a baseline visit.	45.0 units on a scale STANDARD_DEVIATION 10.6 • n=164 Participants • We were not able to collect all values from all participants that completed a baseline visit.
Baseline Quality of Life Measures by Arm - ESS	9.0 units on a scale STANDARD_DEVIATION 4.9 • n=44 Participants	8.0 units on a scale STANDARD_DEVIATION 4.2 • n=42 Participants	7.8 units on a scale STANDARD_DEVIATION 4.2 • n=42 Participants	8.4 units on a scale STANDARD_DEVIATION 4.8 • n=41 Participants	8.3 units on a scale STANDARD_DEVIATION 4.5 • n=169 Participants
Baseline Quality of Life Measures by Arm - PHQ-8	5.0 units on a scale STANDARD_DEVIATION 4.6 • n=42 Participants • We were not able to collect all values from all participants that completed a baseline visit.	5.1 units on a scale STANDARD_DEVIATION 4.1 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	4.7 units on a scale STANDARD_DEVIATION 5.1 • n=38 Participants • We were not able to collect all values from all participants that completed a baseline visit.	6.4 units on a scale STANDARD_DEVIATION 5.6 • n=40 Participants • We were not able to collect all values from all participants that completed a baseline visit.	5.3 units on a scale STANDARD_DEVIATION 4.9 • n=160 Participants • We were not able to collect all values from all participants that completed a baseline visit.
Baseline Quality of Life Measures by Arm - SAQLI	4.8 units on a scale STANDARD_DEVIATION 0.8 • n=43 Participants • We were not able to collect all values from all participants that completed a baseline visit.	4.8 units on a scale STANDARD_DEVIATION 0.8 • n=41 Participants • We were not able to collect all values from all participants that completed a baseline visit.	4.9 units on a scale STANDARD_DEVIATION 0.9 • n=41 Participants • We were not able to collect all values from all participants that completed a baseline visit.	4.7 units on a scale STANDARD_DEVIATION 1.0 • n=41 Participants • We were not able to collect all values from all participants that completed a baseline visit.	4.8 units on a scale STANDARD_DEVIATION 0.9 • n=166 Participants • We were not able to collect all values from all participants that completed a baseline visit.

PRIMARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint.

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=69 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=69 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms 24-hour Systolic Blood Pressure	1.82 mmHg Standard Deviation 13.01	1.06 mmHg Standard Deviation 8.26	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms 24-hour Diastolic Blood Pressure	0.59 mmHg Standard Deviation 6.08	-0.73 mmHg Standard Deviation 4.81	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms 24-hour Mean Arterial Pressure	1.00 mmHg Standard Deviation 8.20	-0.14 mmHg Standard Deviation 5.76	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms Sleep Systolic Blood Pressure	3.36 mmHg Standard Deviation 16.65	-0.21 mmHg Standard Deviation 10.79	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms Sleep Diastolic Blood Pressure	1.25 mmHg Standard Deviation 8.81	-0.51 mmHg Standard Deviation 5.95	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms Sleep Mean Arterial Pressure	1.84 mmHg Standard Deviation 10.79	-0.37 mmHg Standard Deviation 7.24	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms Wake Systolic Blood Pressure	1.86 mmHg Standard Deviation 12.08	1.42 mmHg Standard Deviation 9.86	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms Wake Diastolic Blood Pressure	0.51 mmHg Standard Deviation 6.10	-0.95 mmHg Standard Deviation 5.79	—	—
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms Wake Mean Arterial Pressure	0.81 mmHg Standard Deviation 7.69	-0.13 mmHg Standard Deviation 6.42	—	—

PRIMARY outcome

Timeframe: 6-months

Population: Intent to treat population for those assigned to Active PAP (all individuals who were randomized to one of the two PAP arms).

Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=42 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=41 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Difference in CPAP Adherence by Active Treatment Arm	3.3 hours/night Standard Deviation 2.7	4.4 hours/night Standard Deviation 2.9	—	—

PRIMARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=32 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=35 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=34 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) Wake Mean Arterial Pressure	0.73 mmHg Standard Deviation 9.04	0.91 mmHg Standard Deviation 5.90	-0.15 mmHg Standard Deviation 7.20	-0.10 mmHg Standard Deviation 5.63
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) Wake Diastolic Blood Pressure	0.75 mmHg Standard Deviation 7.08	0.24 mmHg Standard Deviation 4.84	-1.06 mmHg Standard Deviation 6.22	-0.83 mmHg Standard Deviation 5.42
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) Sleep Mean Arterial Pressure	0.93 mmHg Standard Deviation 11.87	2.89 mmHg Standard Deviation 9.46	-0.74 mmHg Standard Deviation 8.23	0.02 mmHg Standard Deviation 6.13
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) Wake Systolic Blood Pressure	1.83 mmHg Standard Deviation 13.65	1.89 mmHg Standard Deviation 10.18	1.69 mmHg Standard Deviation 10.64	1.14 mmHg Standard Deviation 9.14
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) 24-hour Systolic Blood Pressure	1.69 mmHg Standard Deviation 13.17	1.96 mmHg Standard Deviation 13.02	1.30 mmHg Standard Deviation 8.75	0.80 mmHg Standard Deviation 7.83
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) 24-hour Diastolic Blood Pressure	0.43 mmHg Standard Deviation 6.78	0.77 mmHg Standard Deviation 5.22	-0.82 mmHg Standard Deviation 4.82	-0.63 mmHg Standard Deviation 4.88
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) 24-hour Mean Arterial Pressure	0.85 mmHg Standard Deviation 8.81	1.17 mmHg Standard Deviation 7.55	-0.11 mmHg Standard Deviation 5.98	-0.16 mmHg Standard Deviation 5.61
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) Sleep Systolic Blood Pressure	2.1 mmHg Standard Deviation 17.84	4.81 mmHg Standard Deviation 15.32	-1.02 mmHg Standard Deviation 12.08	0.65 mmHg Standard Deviation 9.36
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) Sleep Diastolic Blood Pressure	0.51 mmHg Standard Deviation 9.08	2.1 mmHg Standard Deviation 8.55	-0.88 mmHg Standard Deviation 6.58	-0.12 mmHg Standard Deviation 5.27

PRIMARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=40 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=35 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms 24-hour Systolic Blood Pressure	0.37 mmHg Standard Deviation 16.52	0.17 mmHg Standard Deviation 8.95	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms 24-hour Diastolic Blood Pressure	-0.22 mmHg Standard Deviation 6.48	-1.57 mmHg Standard Deviation 5.12	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms 24-hour Mean Arterial Pressure	-0.03 mmHg Standard Deviation 9.33	-0.99 mmHg Standard Deviation 6.15	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms Sleep Systolic Blood Pressure	2.61 mmHg Standard Deviation 21.74	-1.09 mmHg Standard Deviation 14.31	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms Sleep Diastolic Blood Pressure	0.57 mmHg Standard Deviation 10.02	-1.39 mmHg Standard Deviation 7.87	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms Sleep Mean Arterial Pressure	0.83 mmHg Standard Deviation 12.79	-1.10 mmHg Standard Deviation 9.57	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms Wake Systolic Blood Pressure	-0.71 mmHg Standard Deviation 16.60	-0.40 mmHg Standard Deviation 11.82	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms Wake Diastolic Blood Pressure	-0.78 mmHg Standard Deviation 6.90	-2.16 mmHg Standard Deviation 6.82	—	—
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms Wake Mean Arterial Pressure	-0.80 mmHg Standard Deviation 9.75	-1.16 mmHg Standard Deviation 7.61	—	—

PRIMARY outcome

Timeframe: 6-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=64 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=66 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms 24-hour Systolic Blood Pressure	2.60 mmHg Standard Deviation 9.90	1.24 mmHg Standard Deviation 8.78	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms 24-hour Diastolic Blood Pressure	0.97 mmHg Standard Deviation 5.50	-0.53 mmHg Standard Deviation 5.16	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms 24-hour Mean Arterial Pressure	1.52 mmHg Standard Deviation 6.80	0.06 mmHg Standard Deviation 6.14	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms Sleep Systolic Blood Pressure	4.58 mmHg Standard Deviation 14.28	-0.18 mmHg Standard Deviation 10.64	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms Sleep Diastolic Blood Pressure	2.07 mmHg Standard Deviation 8.20	-0.27 mmHg Standard Deviation 6.01	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms Sleep Mean Arterial Pressure	2.94 mmHg Standard Deviation 9.41	-0.30 mmHg Standard Deviation 7.19	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms Wake Systolic Blood Pressure	2.84 mmHg Standard Deviation 11.05	2.10 mmHg Standard Deviation 10.31	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms Wake Diastolic Blood Pressure	0.93 mmHg Standard Deviation 6.25	-0.61 mmHg Standard Deviation 6.04	—	—
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms Wake Mean Arterial Pressure	1.42 mmHg Standard Deviation 7.31	0.29 mmHg Standard Deviation 6.78	—	—

PRIMARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=18 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=18 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=17 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) Wake Systolic Blood Pressure	-1.91 mmHg Standard Deviation 14.84	0.74 mmHg Standard Deviation 18.87	-0.75 mmHg Standard Deviation 15.15	-0.02 mmHg Standard Deviation 7.27
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) Wake Diastolic Blood Pressure	-0.91 mmHg Standard Deviation 7.60	-0.62 mmHg Standard Deviation 6.15	-2.25 mmHg Standard Deviation 8.00	-2.06 mmHg Standard Deviation 5.55
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) Wake Mean Arterial Pressure	-1.44 mmHg Standard Deviation 10.54	-0.005 mmHg Standard Deviation 8.92	-1.59 mmHg Standard Deviation 9.91	-0.71 mmHg Standard Deviation 4.28
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) 24-hour Systolic Blood Pressure	-0.97 mmHg Standard Deviation 15.36	2.22 mmHg Standard Deviation 18.36	-0.09 mmHg Standard Deviation 10.42	0.45 mmHg Standard Deviation 7.41
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) 24-hour Diastolic Blood Pressure	-0.68 mmHg Standard Deviation 7.32	0.40 mmHg Standard Deviation 5.29	-1.61 mmHg Standard Deviation 5.00	-1.53 mmHg Standard Deviation 5.40
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) 24-hour Mean Arterial Pressure	-0.78 mmHg Standard Deviation 9.90	1.01 mmHg Standard Deviation 8.68	-1.10 mmHg Standard Deviation 6.64	-0.87 mmHg Standard Deviation 5.78
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) Sleep Systolic Blood Pressure	0.40 mmHg Standard Deviation 22.7	5.48 mmHg Standard Deviation 20.82	-3.79 mmHg Standard Deviation 17.02	1.94 mmHg Standard Deviation 10.17
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) Sleep Diastolic Blood Pressure	-0.52 mmHg Standard Deviation 10.47	1.97 mmHg Standard Deviation 9.53	-2.54 mmHg Standard Deviation 9.17	-0.11 mmHg Standard Deviation 6.12
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) Sleep Mean Arterial Pressure	-0.51 mmHg Standard Deviation 14.00	2.57 mmHg Standard Deviation 11.21	-2.88 mmHg Standard Deviation 11.44	0.91 mmHg Standard Deviation 6.71

PRIMARY outcome

Timeframe: 6-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.

Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=34 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=30 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=34 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=32 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) 24-hour Systolic Blood Pressure	2.45 mmHg Standard Deviation 10.77	2.77 mmHg Standard Deviation 9.04	2.12 mmHg Standard Deviation 8.94	0.29 mmHg Standard Deviation 8.65
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) 24-hour Diastolic Blood Pressure	0.85 mmHg Standard Deviation 6.08	1.11 mmHg Standard Deviation 4.89	-0.40 mmHg Standard Deviation 5.15	-0.67 mmHg Standard Deviation 5.24
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) 24-hour Mean Arterial Pressure	1.38 mmHg Standard Deviation 7.53	1.67 mmHg Standard Deviation 6.01	0.44 mmHg Standard Deviation 6.23	-0.35 mmHg Standard Deviation 6.12
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) Wake Systolic Blood Pressure	3.31 mmHg Standard Deviation 13.20	2.33 mmHg Standard Deviation 8.26	3.14 mmHg Standard Deviation 10.02	0.99 mmHg Standard Deviation 10.67
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) Wake Diastolic Blood Pressure	1.46 mmHg Standard Deviation 7.26	0.36 mmHg Standard Deviation 4.96	-0.50 mmHg Standard Deviation 6.14	-0.72 mmHg Standard Deviation 6.02
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) Wake Mean Arterial Pressure	1.77 mmHg Standard Deviation 8.81	1.04 mmHg Standard Deviation 5.34	0.70 mmHg Standard Deviation 6.97	-0.13 mmHg Standard Deviation 6.65
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) Sleep Systolic Blood Pressure	3.67 mmHg Standard Deviation 12.37	5.59 mmHg Standard Deviation 16.29	-0.21 mmHg Standard Deviation 11.91	-0.15 mmHg Standard Deviation 9.30
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) Sleep Diastolic Blood Pressure	1.53 mmHg Standard Deviation 7.09	2.65 mmHg Standard Deviation 9.37	-0.21 mmHg Standard Deviation 6.51	-0.34 mmHg Standard Deviation 5.53
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) Sleep Mean Arterial Pressure	2.34 mmHg Standard Deviation 8.75	3.60 mmHg Standard Deviation 10.20	-0.10 mmHg Standard Deviation 8.08	-0.50 mmHg Standard Deviation 6.22

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=32 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=36 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=34 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Physical Component	-1.3 units on a scale Standard Deviation 7.3	-1.3 units on a scale Standard Deviation 6.4	1.1 units on a scale Standard Deviation 4.7	1.8 units on a scale Standard Deviation 4.7
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Mental Component	0.6 units on a scale Standard Deviation 7.6	2.9 units on a scale Standard Deviation 6.4	3.9 units on a scale Standard Deviation 8.4	2.2 units on a scale Standard Deviation 6.3
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Vitality Subscale	0.9 units on a scale Standard Deviation 14.3	5.6 units on a scale Standard Deviation 11.4	12.7 units on a scale Standard Deviation 14.9	6.4 units on a scale Standard Deviation 12.6
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Physical Functioning	-1.8 units on a scale Standard Deviation 16.5	0.4 units on a scale Standard Deviation 14.4	3.3 units on a scale Standard Deviation 11.2	3.1 units on a scale Standard Deviation 13.9
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Bodily Pain	-1.7 units on a scale Standard Deviation 18.8	-3.4 units on a scale Standard Deviation 23.2	4.1 units on a scale Standard Deviation 14.4	7.8 units on a scale Standard Deviation 19.4
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 General Health Perceptions	-4.4 units on a scale Standard Deviation 17.2	-0.04 units on a scale Standard Deviation 15.8	5.0 units on a scale Standard Deviation 12.6	7.1 units on a scale Standard Deviation 14.6
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Physical Role Functioning	-2.2 units on a scale Standard Deviation 21.3	-0.9 units on a scale Standard Deviation 22.2	3.4 units on a scale Standard Deviation 15.9	-2.11 units on a scale Standard Deviation 17.3
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Emotional Role Functioning	0 units on a scale Standard Deviation 20.1	9.2 units on a scale Standard Deviation 27.1	3.7 units on a scale Standard Deviation 19.5	5.2 units on a scale Standard Deviation 22.4
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Social Role Functioning	1.8 units on a scale Standard Deviation 17.7	0.4 units on a scale Standard Deviation 14.1	4.5 units on a scale Standard Deviation 15.4	3.7 units on a scale Standard Deviation 14.1
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) SF-36 Mental Health	-0.5 units on a scale Standard Deviation 13.4	1.1 units on a scale Standard Deviation 9.1	6.1 units on a scale Standard Deviation 15.6	1.1 units on a scale Standard Deviation 11.5

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=32 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=36 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=34 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Epworth Sleepiness Scale (ESS) (4 Arm)	-0.6 units on a scale Standard Deviation 3.1	-1.0 units on a scale Standard Deviation 3.3	-1.9 units on a scale Standard Deviation 3.1	-1.6 units on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=32 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=35 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=33 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Patient Health Questionnaire (PHQ8) (4 Arm)	-0.4 units on a scale Standard Deviation 3.2	-0.9 units on a scale Standard Deviation 2.5	-1.7 units on a scale Standard Deviation 3.9	-1.4 units on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=32 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=36 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=33 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm)	0.1 units on a scale Standard Deviation 0.4	0.2 units on a scale Standard Deviation 0.6	-0.1 units on a scale Standard Deviation 0.7	-0.1 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=34 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=35 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=33 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in C-Reactive Protein at Months 6 and 12 (4 Arm) InCRP	0.2 mg/L Standard Deviation 0.6	-0.02 mg/L Standard Deviation 0.8	0.0003 mg/L Standard Deviation 0.6	0.2 mg/L Standard Deviation 0.5
Change in C-Reactive Protein at Months 6 and 12 (4 Arm) InCRP (excluding raw >10)	0.2 mg/L Standard Deviation 0.6	0.1 mg/L Standard Deviation 0.6	0.1 mg/L Standard Deviation 0.5	0.1 mg/L Standard Deviation 0.5

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Lipid measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=34 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=35 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=33 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Lipid Panel at 6 and 12 Months (4 Arm) Triglycerides	9.4 mg/dL Standard Deviation 56.9	1.5 mg/dL Standard Deviation 47.1	4.0 mg/dL Standard Deviation 37.3	1.8 mg/dL Standard Deviation 28.8
Change in Lipid Panel at 6 and 12 Months (4 Arm) HDL Cholesterol	-0.5 mg/dL Standard Deviation 5.2	1.7 mg/dL Standard Deviation 6.8	-0.7 mg/dL Standard Deviation 7.8	-0.05 mg/dL Standard Deviation 5.2
Change in Lipid Panel at 6 and 12 Months (4 Arm) LDL Cholesterol	5.1 mg/dL Standard Deviation 17.5	2.5 mg/dL Standard Deviation 20.5	1.4 mg/dL Standard Deviation 16.5	6.0 mg/dL Standard Deviation 19.0
Change in Lipid Panel at 6 and 12 Months (4 Arm) Total Cholesterol	5.6 mg/dL Standard Deviation 19.5	4.5 mg/dL Standard Deviation 27.3	0.7 mg/dL Standard Deviation 19.5	6.3 mg/dL Standard Deviation 20.6
Change in Lipid Panel at 6 and 12 Months (4 Arm) VLDL Cholesterol	0.3 mg/dL Standard Deviation 5.7	0.2 mg/dL Standard Deviation 9.5	0.1 mg/dL Standard Deviation 8.0	0.2 mg/dL Standard Deviation 5.8

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=34 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=35 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=33 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) Fibrinogen	18.9 mg/dL Standard Deviation 56.3	-2.0 mg/dL Standard Deviation 72.7	2.75 mg/dL Standard Deviation 45.5	11.9 mg/dL Standard Deviation 63.8
Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) B-type Natriuretic Peptide (BNP)	-34.3 mg/dL Standard Deviation 111.6	4.7 mg/dL Standard Deviation 138.7	19.1 mg/dL Standard Deviation 175.1	-3.3 mg/dL Standard Deviation 68.7
Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) Glucose	2.9 mg/dL Standard Deviation 16.2	3.9 mg/dL Standard Deviation 47.1	10.9 mg/dL Standard Deviation 45.9	1.0 mg/dL Standard Deviation 12.3
Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) Urine Creatinine	-7.8 mg/dL Standard Deviation 62.9	-9.5 mg/dL Standard Deviation 66.1	8.7 mg/dL Standard Deviation 50.5	-5.4 mg/dL Standard Deviation 41.0
Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) Serum Creatinine	-0.007 mg/dL Standard Deviation 0.1	-0.01 mg/dL Standard Deviation 0.1	-0.01 mg/dL Standard Deviation 0.1	0.007 mg/dL Standard Deviation 0.1

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=33 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=34 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=32 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm)	0.1 percentage glycosylated hemoglobin Standard Deviation 0.4	-0.2 percentage glycosylated hemoglobin Standard Deviation 0.6	-0.04 percentage glycosylated hemoglobin Standard Deviation 0.5	0.1 percentage glycosylated hemoglobin Standard Deviation 0.4

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=33 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=36 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=32 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm)	-0.9 uIU/mL Standard Deviation 6.7	2.8 uIU/mL Standard Deviation 12.0	-2.4 uIU/mL Standard Deviation 15.4	1.1 uIU/mL Standard Deviation 5.9

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=32 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=36 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=32 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm)	5.3 pg/dL Standard Deviation 30.2	0.5 pg/dL Standard Deviation 2.7	-2.5 pg/dL Standard Deviation 15.6	0.4 pg/dL Standard Deviation 2.1

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=34 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=33 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=32 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=31 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm)	-0.2 mL/min/1.73m^2 Standard Deviation 9.9	0.6 mL/min/1.73m^2 Standard Deviation 11.0	0.007 mL/min/1.73m^2 Standard Deviation 8.3	-1.15 mL/min/1.73m^2 Standard Deviation 9.1

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=34 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=33 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=31 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Urine Microalbumin at Months 6 and 12 (4 Arm)	-16.7 ug/mL Standard Deviation 31.2	45.4 ug/mL Standard Deviation 315.7	3.7 ug/mL Standard Deviation 43.0	8.2 ug/mL Standard Deviation 58.2

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=34 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=33 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=31 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm)	-9.3 ug/mg Standard Deviation 29.4	84.6 ug/mg Standard Deviation 568.0	1.2 ug/mg Standard Deviation 55.9	6.0 ug/mg Standard Deviation 58.8

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=33 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=35 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=32 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm)	0.8 AU/mL Standard Deviation 2.5	0.2 AU/mL Standard Deviation 3.7	1.1 AU/mL Standard Deviation 6.9	0.3 AU/mL Standard Deviation 4.0

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=27 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=26 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=31 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=24 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms)	0.05 m/s Standard Deviation 1.9	-0.03 m/s Standard Deviation 1.5	-0.2 m/s Standard Deviation 2.0	0.1 m/s Standard Deviation 1.1

SECONDARY outcome

Timeframe: Mean of 6- and 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=35 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=28 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=31 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=29 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Change in Augmentation Index at Months 6 and 12 (4 Arms)	-1.2 percent of central pulse pressure Standard Deviation 9.2	-0.4 percent of central pulse pressure Standard Deviation 8.0	0.9 percent of central pulse pressure Standard Deviation 7.5	-0.9 percent of central pulse pressure Standard Deviation 8.0

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline Left Ventricular Mass Index measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=37 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=37 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=39 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=37 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Left Ventricular (LV) Mass Index (4 Arm) - Baseline	82.4 g/m2 Standard Deviation 15.7	78.5 g/m2 Standard Deviation 16.4	77.0 g/m2 Standard Deviation 19.0	76.3 g/m2 Standard Deviation 18.9

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline Left Atrial Mass Index measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=37 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=39 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=37 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Left Atrial (LA) Volume Index (4 Arm) - Baseline	27.1 m/m2 Standard Deviation 11.0	25.3 m/m2 Standard Deviation 10.6	25.1 m/m2 Standard Deviation 6.9	24.2 m/m2 Standard Deviation 7.7

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline End-Diastolic Volume measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=37 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=38 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=37 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
End-Diastolic Volume (4 Arm) - Baseline	113.8 cm Standard Deviation 18.2	111.8 cm Standard Deviation 19.8	113.4 cm Standard Deviation 22.8	112.3 cm Standard Deviation 19.7

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline Ejection Fraction measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=37 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=38 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=37 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Ejection Fraction (4 Arm) - Baseline	60.2 percent ejection fraction Standard Deviation 4.1	60.9 percent ejection fraction Standard Deviation 2.7	60.8 percent ejection fraction Standard Deviation 6.6	59.9 percent ejection fraction Standard Deviation 4.6

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline RV Fractional Area Change measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=35 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=34 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=33 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=36 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Right Ventricular Fractional Area Change (4 Arm) - Baseline	0.5 percentage change in RV area Standard Deviation 0.1	0.5 percentage change in RV area Standard Deviation 0.0	0.5 percentage change in RV area Standard Deviation 0.1	0.5 percentage change in RV area Standard Deviation 0.0

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=34 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=35 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=38 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=34 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline	14.2 cm/sec Standard Deviation 3.5	13.1 cm/sec Standard Deviation 3.0	13.5 cm/sec Standard Deviation 2.4	13.1 cm/sec Standard Deviation 3.1

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline Pulmonary Vascular Resistance measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=19 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=22 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=20 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Pulmonary Vascular Resistance (4 Arm) - Baseline	154.6 Wood units Standard Deviation 30.1	135.5 Wood units Standard Deviation 40.3	151.1 Wood units Standard Deviation 35.2	157.0 Wood units Standard Deviation 39.1

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline E/Em Lateral Ratio measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=38 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=36 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=39 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=36 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
E/Em Lateral Ratio (4 Arm) - Baseline	8.6 mitral velocity ratio (absolute units) Standard Deviation 3.4	8.3 mitral velocity ratio (absolute units) Standard Deviation 2.7	8.4 mitral velocity ratio (absolute units) Standard Deviation 2.7	7.9 mitral velocity ratio (absolute units) Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=23 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=21 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=23 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=21 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline	243.5 cm/sec Standard Deviation 22.1	240.4 cm/sec Standard Deviation 23.9	244.0 cm/sec Standard Deviation 21.3	248.3 cm/sec Standard Deviation 30.7

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint Left Ventricular Mass Index measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=17 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=15 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=16 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Left Ventricular Mass Index (4 Arm) - 12 Month	82.1 g/m2 Standard Deviation 17.3	76.9 g/m2 Standard Deviation 15.6	74.2 g/m2 Standard Deviation 23.7	70.4 g/m2 Standard Deviation 18.0

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint Left Atrial Volume Index measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=17 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=15 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=16 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Left Atrial Volume Index (4 Arm) - 12 Month	25.5 m/m2 Standard Deviation 11.7	22.3 m/m2 Standard Deviation 6.7	24.6 m/m2 Standard Deviation 6.4	20.7 m/m2 Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint End-Diastolic Volume measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=17 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=16 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=16 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
End-Diastolic Volume (4 Arm) - 12 Month	110.7 cm Standard Deviation 17.4	112.3 cm Standard Deviation 19.6	115.5 cm Standard Deviation 26.9	106.1 cm Standard Deviation 14.0

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint Ejection Fraction measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=17 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=16 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=16 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Ejection Fraction (4 Arm) - 12 Month	61.1 percentage ejection fraction Standard Deviation 4.7	61.4 percentage ejection fraction Standard Deviation 4.2	60.6 percentage ejection fraction Standard Deviation 5.1	60.9 percentage ejection fraction Standard Deviation 2.7

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint Right Ventricular Fractional Area Change measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=21 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=14 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=16 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=15 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Right Ventricular Fractional Area Change (4 Arm) - 12 Month	0.5 percentage change in RV area Standard Deviation 0.0	0.5 percentage change in RV area Standard Deviation 0.0	0.5 percentage change in RV area Standard Deviation 0.0	0.5 percentage change in RV area Standard Deviation 0.0

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=21 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=17 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=16 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=15 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month	14.1 cm/sec Standard Deviation 3.6	13.5 cm/sec Standard Deviation 2.5	13.6 cm/sec Standard Deviation 2.5	14.1 cm/sec Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint Pulmonary Vascular Resistance measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=14 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=7 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=8 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=9 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Pulmonary Vascular Resistance (4 Arm) - 12 Month	148.4 Wood units Standard Deviation 26.7	138.2 Wood units Standard Deviation 16.6	144.0 Wood units Standard Deviation 54.8	131.3 Wood units Standard Deviation 29.1

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

Endpoint E/Em Lateral Ratio measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=22 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=17 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=16 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=16 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
E/Em Lateral Ratio (4 Arm) - 12 Month	8.8 mitral velocity ratio (absolute units) Standard Deviation 3.2	8.2 mitral velocity ratio (absolute units) Standard Deviation 2.5	9.2 mitral velocity ratio (absolute units) Standard Deviation 2.9	8.4 mitral velocity ratio (absolute units) Standard Deviation 2.8

SECONDARY outcome

Timeframe: 12-months

Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).

12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography.

Outcome measures

Outcome measures
Measure	Control Arms (Pooled) n=14 Participants Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.	Active Treatment Arms (Pooled) n=7 Participants Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.	Active PAP With RT Support (Active-Beh) n=8 Participants In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.	Active PAP With Behavioral Modification (Active+Beh) n=10 Participants In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month	235.4 cm/sec Standard Deviation 32.9	253.1 cm/sec Standard Deviation 35.0	232.0 cm/sec Standard Deviation 13.6	254.7 cm/sec Standard Deviation 23.3

Adverse Events

Conservative Medical Therapy (CMT)

Serious events: 7 serious events

Other events: 17 other events

Deaths: 0 deaths

Sham PAP (Sham)

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Active PAP With RT Support (Active-Beh)

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Active PAP With Behavioral Modification (Active+Beh)

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Susan Redline

Brigham and Women's Hospital

Phone: 617-732-5859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place