Back to resultsObstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
Primary Purpose
Obstructive Sleep Apnea, Coronary Heart Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP
HLSE
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Coronary heart disease, Cardiac rehabilitation, Cardiopulmonary exercise testing
Eligibility Criteria
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.
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Continuous Positive Airway Pressure (CPAP)
Healthy Lifestyle and Sleep Education (HLSE)
Arm Description
Continuous positive airway pressure
Healthy living and sleep education
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02005445
First Posted
December 3, 2013
Last Updated
July 1, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02005445
Brief Title
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
Official Title
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet recruitment target
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
June 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Coronary Heart Disease
Keywords
Obstructive sleep apnea, Coronary heart disease, Cardiac rehabilitation, Cardiopulmonary exercise testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Positive Airway Pressure (CPAP)
Arm Type
Experimental
Arm Description
Continuous positive airway pressure
Arm Title
Healthy Lifestyle and Sleep Education (HLSE)
Arm Type
Sham Comparator
Arm Description
Healthy living and sleep education
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure
Intervention Type
Behavioral
Intervention Name(s)
HLSE
Intervention Description
Healthy living and sleep education
Primary Outcome Measure Information:
Title
WHO Disability Assessment Scale 2 Scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Gottlieb, MD MPH
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
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