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Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02005445
First received: December 3, 2013
Last updated: June 3, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Peak O2 consumption on cardiopulmonary exercise testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Peak O2 consumption on cardiopulmonary exercise testing


Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (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. We 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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
Investigators
Principal Investigator: Daniel J. Gottlieb, MD MPH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02005445     History of Changes
Other Study ID Numbers: F1351-P
Study First Received: December 3, 2013
Last Updated: June 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Obstructive sleep apnea
Coronary heart disease
Cardiac rehabilitation
Cardiopulmonary exercise testing

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

ClinicalTrials.gov processed this record on August 01, 2014