Trial Outcomes & Findings for Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea (NCT NCT00988351)

NCT ID: NCT00988351

Last Updated: 2014-11-03

Results Overview

average nightly hours of using positive airway pressure (including 0 for nights not used)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 156 participants
• Primary outcome timeframe: 6 weeks after starting treatment
• Results posted on: 2014-11-03

Participant Flow

Participant milestones

Measure	PSG CPAP Titration Then CPAP Treatment Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Overall Study STARTED	78	78
Overall Study CPAP Titration	78	78
Overall Study PAP Setup	70	78
Overall Study Clinic Visit	64	69
Overall Study Using CPAP or APAP	59	66
Overall Study COMPLETED	59	66
Overall Study NOT COMPLETED	19	12

Reasons for withdrawal

Measure	PSG CPAP Titration Then CPAP Treatment Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Overall Study Withdrawal by Subject	8	0
Overall Study Lost to Follow-up	6	9
Overall Study not using CPAP	5	3

Baseline Characteristics

Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea

Baseline characteristics by cohort

Measure	PSG CPAP Titration Then CPAP Treatment n=78 Participants Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=78 Participants Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)	Total n=156 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.9 • n=5 Participants	58.3 years STANDARD_DEVIATION 12.0 • n=7 Participants	58.7 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	56 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	78 participants n=7 Participants	156 participants n=5 Participants
Body mass index	34.9 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants	34.2 kg/m^2 STANDARD_DEVIATION 5.8 • n=7 Participants	34.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants
apnea+hypopnea index	31.0 number of apneas and hypopneas /hour STANDARD_DEVIATION 19.1 • n=5 Participants	28.6 number of apneas and hypopneas /hour STANDARD_DEVIATION 18.2 • n=7 Participants	29.8 number of apneas and hypopneas /hour STANDARD_DEVIATION 18.6 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after starting treatment

Population: patients using cpap or apap at clinic visit

average nightly hours of using positive airway pressure (including 0 for nights not used)

Outcome measures

Measure	PSG CPAP Titration Then CPAP Treatment n=59 Participants Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=66 Participants Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Positive Airway Pressure Adherence (Nightly Use of Treatment)	3.99 hours Standard Deviation 2.3	4.45 hours Standard Deviation 2.3

SECONDARY outcome

Timeframe: 6 weeks after starting treatment

Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.

Outcome measures

Measure	PSG CPAP Titration Then CPAP Treatment n=59 Participants Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=66 Participants Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Change in Epworth Sleepiness Scale	-3.7 units on a scale Standard Deviation 4.8	-4.1 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 6 weeks at clinic

Population: Using PAP 1/2 hour or more nightly

The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.

Outcome measures

Measure	PSG CPAP Titration Then CPAP Treatment n=59 Participants Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=66 Participants Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Change in Functional Outcomes of Sleep Questionnaire	2.2 units on a scale Standard Deviation 3.7	2.6 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: over first 6 weeks of treatment

Population: participants using PAP at clinic visit (\>= 1/2 hour of nightly use)

The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.

Outcome measures

Measure	PSG CPAP Titration Then CPAP Treatment n=59 Participants Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=66 Participants Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Residual Apnea-hypopnea Index	4.9 events (apneas+hypopneas)/hour Standard Deviation 4.9	5.5 events (apneas+hypopneas)/hour Standard Deviation 4.7

SECONDARY outcome

Timeframe: 6 weeks clinic

Population: participants using PAP at the 6 weeks clinic visit

The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.

Outcome measures

Measure	PSG CPAP Titration Then CPAP Treatment n=59 Participants Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=66 Participants Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
Treatment Pressure (Level of CPAP or 90th Percentile APAP)	11.7 cm H2O Standard Deviation 2.5	10.8 cm H2O Standard Deviation 3.1

Adverse Events

PSG CPAP Titration Then CPAP Treatment

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Auto-Adjusting Positive Airway Pressure

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PSG CPAP Titration Then CPAP Treatment n=78 participants at risk Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration	Auto-Adjusting Positive Airway Pressure n=78 participants at risk Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)
General disorders PAP treatment intolerance	24.4% 19/78 • Number of events 19 • Study duration	15.4% 12/78 • Number of events 12 • Study duration

Additional Information

Dr. Richard B. Berry

Malcom Randall VA

Phone: 3522621575

Email: Richard.Berry@medicine.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place