Trial Outcomes & Findings for The Effects of Treating Obese and Lean Patients With Sleep Apnea (NCT NCT01578031)
NCT ID: NCT01578031
Last Updated: 2019-07-05
Results Overview
Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
4 months
Results posted on
2019-07-05
Participant Flow
The number of participants enrolled is the number of participants who agreed to participate in the study following completion of the informed consent process. The number of participants Started is the number of participants who were assigned to each Arm/Group.
Participant milestones
| Measure |
Obese Patients With Obstructive Sleep Apnea
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Obese Subjects Without OSA
Control.
Usual Care: Usual care.
|
Non-obese Subjects Without OSA
Control.
Usual Care: Usual care.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
129
|
69
|
12
|
30
|
|
Overall Study
COMPLETED
|
67
|
35
|
12
|
30
|
|
Overall Study
NOT COMPLETED
|
62
|
34
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Treating Obese and Lean Patients With Sleep Apnea
Baseline characteristics by cohort
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=129 Participants
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=69 Participants
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Obese Subjects Without OSA
n=12 Participants
Control.
Usual Care: Usual care.
|
Non-obese Subjects Without OSA
n=30 Participants
Control.
Usual Care: Usual care.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
240 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
52.7 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
54.3 years
STANDARD_DEVIATION 7.8 • n=27 Participants
|
51.8 years
STANDARD_DEVIATION 5.8 • n=483 Participants
|
53.4 years
STANDARD_DEVIATION 6.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
199 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=93 Participants
|
27 participants
n=4 Participants
|
3 participants
n=27 Participants
|
15 participants
n=483 Participants
|
116 participants
n=36 Participants
|
|
Region of Enrollment
Iceland
|
58 participants
n=93 Participants
|
42 participants
n=4 Participants
|
9 participants
n=27 Participants
|
15 participants
n=483 Participants
|
124 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer's analysis) and have complete data for this outcome.
Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment
Outcome measures
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=88 Participants
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=46 Participants
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
|---|---|---|
|
Change From Baseline in Mean Arterial Blood Pressure
|
-4.21 mm Hg
Interval -7.12 to -1.29
|
-0.95 mm Hg
Interval -4.02 to 2.12
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer's analysis) and have complete data for this outcome.
Change from Baseline in Psychomotor Vigilance Task as measured by number of lapses during 10-minute Reaction time test.
Outcome measures
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=92 Participants
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=50 Participants
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
|---|---|---|
|
Change From Baseline in Psychomotor Vigilance Task
|
-0.27174 lapses
Standard Deviation 2.19
|
-0.7778 lapses
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer's analysis) and have complete data for this outcome.
Change from Baseline in Sympathetic Nervous System Activity as measured by 24-hour urine collection for norepinephrine levels.
Outcome measures
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=104 Participants
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=55 Participants
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
|---|---|---|
|
Change From Baseline in Sympathetic Nervous System Activity
|
-5.9011 mcg/24 hours
Standard Deviation 9.4996
|
-3.0649 mcg/24 hours
Standard Deviation 11.987
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer's analysis) and have complete data for this outcome.
Change from Baseline in Circulating Inflammatory Biomarker: IL-6.
Outcome measures
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=106 Participants
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=54 Participants
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
|---|---|---|
|
Change From Baseline in Circulating Inflammatory Biomarker
|
0.153 pg/mL
Standard Deviation 1.82
|
-0.0211 pg/mL
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data were not collected.
Overnight urinary excretion of 8-isoprostane.
Outcome measures
Outcome data not reported
Adverse Events
Obese Patients With Obstructive Sleep Apnea
Serious events: 5 serious events
Other events: 32 other events
Deaths: 1 deaths
Non-obese Patients With Obstructive Sleep Apnea
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Obese Patients Without Sleep Apnea
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-obese Patients Without Sleep Apnea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=129 participants at risk
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=69 participants at risk
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Obese Patients Without Sleep Apnea
n=12 participants at risk
Control Obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index \< 15
|
Non-obese Patients Without Sleep Apnea
n=30 participants at risk
Control Non-obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index \< 15
|
|---|---|---|---|---|
|
Cardiac disorders
Hospitalization
|
2.3%
3/129 • Number of events 3 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Metabolism and nutrition disorders
Hospitalization
|
0.00%
0/129 • From enrollment until completion of tests and procedures
|
1.4%
1/69 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalizaiton
|
0.00%
0/129 • From enrollment until completion of tests and procedures
|
1.4%
1/69 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
0.78%
1/129 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Infections and infestations
Hospitalization
|
0.78%
1/129 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/129 • From enrollment until completion of tests and procedures
|
2.9%
2/69 • Number of events 2 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
Other adverse events
| Measure |
Obese Patients With Obstructive Sleep Apnea
n=129 participants at risk
Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Non-obese Patients With Obstructive Sleep Apnea
n=69 participants at risk
Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite).
|
Obese Patients Without Sleep Apnea
n=12 participants at risk
Control Obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index \< 15
|
Non-obese Patients Without Sleep Apnea
n=30 participants at risk
Control Non-obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index \< 15
|
|---|---|---|---|---|
|
Cardiac disorders
High blood pressure
|
8.5%
11/129 • Number of events 11 • From enrollment until completion of tests and procedures
|
10.1%
7/69 • Number of events 7 • From enrollment until completion of tests and procedures
|
25.0%
3/12 • Number of events 3 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Psychiatric disorders
Claustrophobia during MRI
|
7.8%
10/129 • Number of events 10 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
8.3%
1/12 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Psychiatric disorders
Abnormal finding on MiniScid
|
8.5%
11/129 • Number of events 11 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
0.00%
0/12 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Gastrointestinal disorders
Abnormal MRI
|
0.00%
0/129 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
8.3%
1/12 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
|
Respiratory, thoracic and mediastinal disorders
Abnormal spirometry
|
0.00%
0/129 • From enrollment until completion of tests and procedures
|
0.00%
0/69 • From enrollment until completion of tests and procedures
|
8.3%
1/12 • Number of events 1 • From enrollment until completion of tests and procedures
|
0.00%
0/30 • From enrollment until completion of tests and procedures
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place