Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-01

Study Completion Date

2018-06-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous Positive Airway Pressure (CPAP)

Continuous positive airway pressure

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Continuous positive airway pressure

Healthy Lifestyle and Sleep Education (HLSE)

Healthy living and sleep education

Group Type SHAM_COMPARATOR

HLSE

Intervention Type BEHAVIORAL

Healthy living and sleep education

Interventions

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CPAP

Continuous positive airway pressure

Intervention Type DEVICE

HLSE

Healthy living and sleep education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No