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Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

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ClinicalTrials.gov Identifier: NCT02005445
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Coronary Heart Disease Device: CPAP Behavioral: HLSE Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : December 29, 2017
Estimated Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CPAP
Continuous positive airway pressure
Device: CPAP
Continuous positive airway pressure
Sham Comparator: HLSE
Healthy living and sleep education
Behavioral: HLSE
Healthy living and sleep education



Primary Outcome Measures :
  1. Functional status [ Time Frame: 12 weeks ]
    Functional status as measured by the WHO Disability Assessment Scale 2 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005445


Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Daniel J Gottlieb, MD MPH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02005445     History of Changes
Other Study ID Numbers: F1351-P
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Obstructive sleep apnea
Coronary heart disease
Cardiac rehabilitation
Cardiopulmonary exercise testing

Additional relevant MeSH terms:
Apnea
Heart Diseases
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases