Trial Outcomes & Findings for Oxygen Versus PAP for Sleep Apnea in Heart Failure (NCT NCT01807897)
NCT ID: NCT01807897
Last Updated: 2023-01-25
Results Overview
Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
3 months
Results posted on
2023-01-25
Participant Flow
Participant milestones
| Measure |
CPAP
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
14
|
|
Overall Study
COMPLETED
|
24
|
27
|
13
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxygen Versus PAP for Sleep Apnea in Heart Failure
Baseline characteristics by cohort
| Measure |
CPAP
n=31 Participants
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
n=29 Participants
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
n=14 Participants
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
71.7 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
70.5 years
STANDARD_DEVIATION 8.1 • n=206 Participants
|
71.9 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants with both baseline and follow-up echocardiograms. There were 5 dropouts from the CPAP group, 2 from the NSO group and 1 from the HLSE group.
Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF.
Outcome measures
| Measure |
CPAP
n=24 Participants
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
n=27 Participants
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
n=13 Participants
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
|---|---|---|---|
|
Left Ventricular Ejection Fraction
|
1.63 percent of LV diastolic volume
Standard Deviation 4.88
|
1.69 percent of LV diastolic volume
Standard Deviation 8.33
|
4.42 percent of LV diastolic volume
Standard Deviation 4.85
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All randomized participants completing baseline and follow-up cardiopulmonary exercise testing
Treadmill exercise testing will be performed using a motor-driven treadmill and a modified Naughton protocol, with a lightweight disposable pneumotach device positioned in the participant's mouth interfaced with a metabolic cart. Change in VO2 peak between baseline and final visit will be the co-primary outcome of the study. Secondary outcome measures from cardiopulmonary exercise testing include VO2 at anaerobic threshold and VE/VCO2 slope.
Outcome measures
| Measure |
CPAP
n=17 Participants
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
n=21 Participants
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
n=7 Participants
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
|---|---|---|---|
|
Peak Oxygen Consumption (VO2 Peak)
|
-0.40 ml/kg/min
Standard Deviation 2.59
|
0.11 ml/kg/min
Standard Deviation 4.75
|
-1.54 ml/kg/min
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants completing 24-hour ambulatory BP monitoring at final visit
24-hour blood pressure will be measured using a blood pressure cuff that is connected by rubber tubing to a small pressure monitoring device, programmed to measure BP at 20 minute intervals during the day and 30 minute intervals at night (11 PM to 7 AM) for a period of 24 hours. The investigators will assess 24-hour mean arterial pressure as the primary blood pressure outcome, with additional assessment of nocturnal versus diurnal blood pressure effects.
Outcome measures
| Measure |
CPAP
n=9 Participants
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
n=14 Participants
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
n=5 Participants
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
|---|---|---|---|
|
24-hour Ambulatory Blood Pressure
|
87.5 torr
Standard Deviation 8.5
|
88.0 torr
Standard Deviation 9.1
|
77.4 torr
Standard Deviation 9.9
|
Adverse Events
CPAP
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Oxygen
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
HLSE
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPAP
n=31 participants at risk
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
n=29 participants at risk
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
n=14 participants at risk
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
|---|---|---|---|
|
Nervous system disorders
Stroke
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Heart failure
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
6.9%
2/29 • Number of events 2 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
7.1%
1/14 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
3.4%
1/29 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
3.4%
1/29 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
7.1%
1/14 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
Other adverse events
| Measure |
CPAP
n=31 participants at risk
Nocturnal continuous positive airway pressure
Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
Oxygen
n=29 participants at risk
Nocturnal supplemental oxygen
Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
HLSE
n=14 participants at risk
Healthy lifestyle and sleep education control
Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
|
|---|---|---|---|
|
Cardiac disorders
Increased dyspnea
|
16.1%
5/31 • Number of events 5 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
13.8%
4/29 • Number of events 4 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
14.3%
2/14 • Number of events 2 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
6.9%
2/29 • Number of events 2 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Nervous system disorders
Excessive sleepiness
|
6.5%
2/31 • Number of events 2 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
10.3%
3/29 • Number of events 3 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
6.9%
2/29 • Number of events 2 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Renal and urinary disorders
Decreased renal function
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
3.4%
1/29 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
General disorders
Toothache
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Injury, poisoning and procedural complications
Fall with injury
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
7.1%
1/14 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/29 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
7.1%
1/14 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/31 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
3.4%
1/29 • Number of events 1 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
0.00%
0/14 • 3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place