Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Not Applicable

Terminated

• Conditions: Coronary Heart Disease; Obstructive Sleep Apnea
• Interventions: Device: CPAP; Behavioral: HLSE

• Registration Number: NCT02005445
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Study Start: 2014-10-01
• Primary Completion: 2017-12-29
• Study Completion: 2018-06-29
• Results First Submitted: 2019-03-19
• Status Verified: 2019-06
• Results First Submitted QC: 2019-07-01
• Last Update Submitted: 2019-07-01
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System.
• Moderate to severe OSA (AHI >15) on home sleep testing.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure (CPAP)	CPAP	Continuous positive airway pressure
Healthy Lifestyle and Sleep Education (HLSE)	HLSE	Healthy living and sleep education

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States