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Trial record 1 of 8 for:    cardiac rehabilitation | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed
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Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

This study is currently recruiting participants.
Verified September 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005445
First Posted: December 9, 2013
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Obstructive Sleep Apnea Coronary Heart Disease Device: CPAP Behavioral: HLSE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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


Estimated Enrollment: 50
Actual Study Start Date: October 1, 2014
Estimated Study Completion Date: March 30, 2018
Estimated Primary Completion Date: December 29, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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


Contacts
Contact: Daniel J Gottlieb, MD MPH (857) 203-6375 daniel.gottlieb@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Daniel J Gottlieb, MD MPH    857-203-6375    daniel.gottlieb@va.gov   
Principal Investigator: Daniel J Gottlieb, MD MPH         
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
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02005445     History of Changes
Other Study ID Numbers: F1351-P
First Submitted: December 3, 2013
First Posted: December 9, 2013
Last Update Posted: September 25, 2017
Last Verified: September 2017
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:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
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