Trial Outcomes & Findings for Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea (NCT NCT00607893)
NCT ID: NCT00607893
Last Updated: 2017-09-15
Results Overview
Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
Measured between baseline and after treatment
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
Sham CPAP
Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.
Sham treatment: Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.
Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
76
|
|
Overall Study
Completed Baseline Visit
|
74
|
75
|
|
Overall Study
Completed 8 Week Visit
|
71
|
72
|
|
Overall Study
Completed 12 Week Visit
|
0
|
29
|
|
Overall Study
COMPLETED
|
71
|
72
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Sham CPAP
Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.
Sham treatment: Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.
Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
withdrew due to loss of interest
|
0
|
1
|
|
Overall Study
Withdrew due to osteomyelitis surgery
|
0
|
1
|
|
Overall Study
withdrew could not tolerate CPAP
|
0
|
1
|
|
Overall Study
Declined to be treated
|
1
|
0
|
|
Overall Study
Withdrew due to hypertensive urgency
|
1
|
1
|
Baseline Characteristics
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
Baseline characteristics by cohort
| Measure |
Treatment CPAP
n=75 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
Sham CPAP
n=74 Participants
Participants used the Sham CPAP every night for 8 weeks.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
74 participants
n=7 Participants
|
149 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured between baseline and after treatmentOxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
F2-isoprostanes/Cr
|
-0.02 ng/mg
Interval -0.12 to 0.1
|
-0.08 ng/mg
Interval -0.18 to 0.03
|
PRIMARY outcome
Timeframe: Measured between baseline and after treatmentOxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Myeloperoxidase
|
-3.33 pmol/L
Interval -17.02 to 10.37
|
-5.15 pmol/L
Interval -18.65 to 8.35
|
SECONDARY outcome
Timeframe: Measured between baseline and after treatmentBlood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Mean Arterial BP, Evening
|
-0.59 mm Hg
Interval -2.53 to 1.35
|
-0.72 mm Hg
Interval -2.65 to 1.2
|
SECONDARY outcome
Timeframe: Measured between baseline and after treatmentPulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Pulse Wave Velocity, Evening
|
-0.08 cm/s
Interval -0.57 to 0.4
|
-0.30 cm/s
Interval -0.8 to 0.2
|
SECONDARY outcome
Timeframe: Measured between baseline and after treatmentMeasures of inflammation outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
IL-6
|
0.29 pg/mL
Interval -0.1 to 0.68
|
-0.08 pg/mL
Interval -0.46 to 0.29
|
SECONDARY outcome
Timeframe: Measured between baseline and after treatmentBlood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Mean Arterial BP, Morning
|
0.24 mm Hg
Interval -1.64 to 2.12
|
-2.17 mm Hg
Interval -4.03 to -0.3
|
SECONDARY outcome
Timeframe: Measured between baseline and after treatmentMeasures of inflammation outcome, logarithm transformed before analysis due to skewed distribution, analyzed change of from baseline with adjustment of baseline. The least squares mean is transformed back to present the percent change from baseline.
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
sIL-6R
|
0.02 percent change
Interval -0.02 to 0.06
|
-0.04 percent change
Interval -0.08 to -0.01
|
SECONDARY outcome
Timeframe: Measured between Months 2 and 3 of treatmentPulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Pulse Wave Velocity, Morning
|
-0.25 cm/s
Interval -0.82 to 0.32
|
-0.42 cm/s
Interval -1.01 to 0.16
|
SECONDARY outcome
Timeframe: Measured between Months 2 and 3 of treatmentPulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Augmentation Index, Evening
|
-0.43 percent change
Interval -3.87 to 3.0
|
-1.79 percent change
Interval -5.36 to 1.78
|
SECONDARY outcome
Timeframe: Measured between Months 2 and 3 of treatmentPulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline
Outcome measures
| Measure |
Sham CPAP
n=71 Participants
Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=72 Participants
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
|---|---|---|
|
Augmentation Index, Morning
|
0.44 percent change
Interval -2.22 to 3.1
|
-6.49 percent change
Interval -9.32 to -3.65
|
Adverse Events
SHAM CPAP
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Treatment CPAP
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Run-in/Washout Treatment CPAP
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Run-in/Washout Sham CPAP
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SHAM CPAP
n=77 participants at risk
Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.
Sham CPAP: Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=76 participants at risk
Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.
Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
Run-in/Washout Treatment CPAP
n=153 participants at risk
The initial run-in and washout period for study qualification to document CPAP adherence on treatment CPAP.
|
Run-in/Washout Sham CPAP
n=153 participants at risk
The initial run-in and washout period for study qualification to document CPAP adherence on Sham CPAP (negligible pressure).
|
|---|---|---|---|---|
|
Cardiac disorders
Chest Pain (went to ER)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Cardiac disorders
Enlarged coronary artieries/chest pain
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Cardiac disorders
Irregular heartbeat (went to ER)
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Cardiac disorders
New onset atrial flutter (shown on psg)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
ER with swollen Knee (hospitalized)
|
0.00%
0/77
|
0.00%
0/76
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Nervous system disorders
Hospitalized for seizures
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Renal and urinary disorders
Dehydration and possible kidney failure
|
0.00%
0/77
|
0.00%
0/76
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia/Influenza
|
0.00%
0/77
|
0.00%
0/76
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Spot on lung - biopsy for cancer
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Surgical and medical procedures
Foot ulcer amputation
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Surgical and medical procedures
Ruptured appendix
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
Other adverse events
| Measure |
SHAM CPAP
n=77 participants at risk
Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.
Sham CPAP: Participants will use the lower pressure CPAP every night for 8 weeks.
|
Treatment CPAP
n=76 participants at risk
Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.
Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
|
Run-in/Washout Treatment CPAP
n=153 participants at risk
The initial run-in and washout period for study qualification to document CPAP adherence on treatment CPAP.
|
Run-in/Washout Sham CPAP
n=153 participants at risk
The initial run-in and washout period for study qualification to document CPAP adherence on Sham CPAP (negligible pressure).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold/congestion
|
0.00%
0/77
|
3.9%
3/76 • Number of events 3
|
2.6%
4/153 • Number of events 4
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Non-productive cough/post nasal drip
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Blood and lymphatic system disorders
Bruise from venipucture
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Blood and lymphatic system disorders
Nose bleeding
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Cardiac disorders
Chest pain
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Cardiac disorders
Elevated blood pressure
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Cardiac disorders
Heart monitor for irregular heartbeat
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Cardiac disorders
Run of nonsustained ventricular tachycardia on PSG
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Eye disorders
Cataract surgery
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Eye disorders
Eye infection/injury
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal cramping
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Metabolism and nutrition disorders
Elevated glucose level
|
16.9%
13/77 • Number of events 13
|
14.5%
11/76 • Number of events 11
|
0.00%
0/153
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Chronic pain
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Developed sciatica
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Fell and bruised rib
|
0.00%
0/77
|
0.00%
0/76
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
General pain (leg, back, muscle)
|
0.00%
0/77
|
6.6%
5/76 • Number of events 5
|
0.00%
0/153
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Hand injury
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Knee replacement
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
auto accident / physical therapy
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Nervous system disorders
Headaches
|
0.00%
0/77
|
0.00%
0/76
|
0.00%
0/153
|
1.3%
2/153 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Breathing problems
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/77
|
0.00%
0/76
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/77
|
0.00%
0/76
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
3.9%
3/77 • Number of events 3
|
3.9%
3/76 • Number of events 3
|
1.3%
2/153 • Number of events 2
|
1.3%
2/153 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Spot on lung (possible cancer)
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Strep throat
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Abrasion on bridge of nose from CPAP mask
|
0.00%
0/77
|
0.00%
0/76
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Cysts on chin
|
0.00%
0/77
|
0.00%
0/76
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Flare up of eczema
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Redness on external nares from nasal pillow mask marks on face from maks
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Tumor removed from finger
|
0.00%
0/77
|
0.00%
0/76
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Ulcer on foot
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
0.00%
0/153
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
scabs on head from electrodes from psg
|
1.3%
1/77 • Number of events 1
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
|
Surgical and medical procedures
Kidney Stone
|
0.00%
0/77
|
1.3%
1/76 • Number of events 1
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Surgical and medical procedures
Tooth extracted/root canal
|
2.6%
2/77 • Number of events 2
|
0.00%
0/76
|
0.00%
0/153
|
0.00%
0/153
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place