Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

NCT02005445 | Terminated Results FDA Device

• 1 other identifier: F1351-P
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Coronary Heart Disease

Keywords

Obstructive sleep apnea; Coronary heart disease; Cardiac rehabilitation; Cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Continuous Positive Airway Pressure (CPAP)

EXPERIMENTAL

Continuous positive airway pressure

Device: CPAP

Healthy Lifestyle and Sleep Education (HLSE)

SHAM COMPARATOR

Healthy living and sleep education

Behavioral: HLSE

Interventions

CPAP DEVICE

Continuous positive airway pressure

Continuous Positive Airway Pressure (CPAP)

HLSE BEHAVIORAL

Healthy living and sleep education

Healthy Lifestyle and Sleep Education (HLSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System.
• Moderate to severe OSA (AHI \>15) on home sleep testing.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Coronary Disease

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Daniel Gottlieb
• Organization: VA Boston Healthcare System

daniel.gottlieb@va.gov

857-203-6375

Study Officials

• Daniel J Gottlieb, MD MPH

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2014
• Primary Completion: December 29, 2017
• Study Completion: June 29, 2018
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)