Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02005445
• Other study ID #: F1351-P
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: June 29, 2018

Study information

• Verified date: June 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 29, 2018
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
Continuous positive airway pressure

Behavioral:
• HLSE
Healthy living and sleep education

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	12 weeks