Coronary Heart Disease, Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Coronary heart disease, Cardiac rehabilitation, Cardiopulmonary exercise testing
Brief summary
This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including impact on exercise capacity, disability, and quality of life.
Detailed description
Obstructive sleep apnea (OSA) is a highly prevalent condition in patients with coronary heart disease and is associated with impaired exercise performance, functional limitation and reduced health-related quality of life. The investigators hypothesize that identification and treatment of OSA in patients undergoing cardiac rehabilitation will improve the response to rehabilitation. The proposed study will test this hypothesis using a parallel group, randomized, clinical trial comparing OSA treatment with continuous positive airway pressure (CPAP) to an educational control group in patients undergoing cardiac rehabilitation who screen positive for previously undiagnosed OSA.
Interventions
DEVICECPAP
Continuous positive airway pressure
BEHAVIORALHLSE
Healthy living and sleep education
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System. * Moderate to severe OSA (AHI \>15) on home sleep testing.
Exclusion criteria
* Dangerous levels of sleepiness (Epworth Sleepiness Scale score \>16 or a report of falling asleep at the wheel of a car within the past 2 years). * Physical limitation precluding exercise testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WHO Disability Assessment Scale 2 Scores | 12 weeks | Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPAP Continuous positive airway pressure
CPAP: Continuous positive airway pressure | 2 |
| HLSE Healthy living and sleep education
HLSE: Healthy living and sleep education | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Dual study enrollment | 0 | 1 |
Baseline characteristics
| Characteristic | CPAP | HLSE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Apnea-hypopnea index | 19.7 events/hour | 25.8 events/hour | 19.9 events/hour |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
WHO Disability Assessment Scale 2 Scores
Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability).
Time frame: 12 weeks
Population: As we were unable to recruit a sufficient number of patients for meaningful analysis, due to closing of the cardiac Rehabilitation program, no analysis was performed. Because there were only 1-2 participants completing the study in each arm, data are not presented due too confidentiality concerns.