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Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

VA Office of Research and Development logo

VA Office of Research and Development

Status

Terminated

Conditions

Coronary Heart Disease
Obstructive Sleep Apnea

Treatments

Device: CPAP
Behavioral: HLSE

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02005445
F1351-P

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4 participants in 2 patient groups

Continuous Positive Airway Pressure (CPAP)
Experimental group
Description:
Continuous positive airway pressure
Treatment:
Device: CPAP
Healthy Lifestyle and Sleep Education (HLSE)
Sham Comparator group
Description:
Healthy living and sleep education
Treatment:
Behavioral: HLSE

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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