Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea (BREATHE)

July 14, 2009 updated by: Brown University

Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time during sleep. The most common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine, but many people have trouble adhering to the treatment schedule. This study will evaluate the effectiveness of two behavioral therapy programs used in combination with CPAP for improving treatment adherence in people with OSA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OSA confirmed by polysomnography (PSG)
  • CPAP is the prescribed form of treatment for OSA
  • Judged by sleep physician to respond to CPAP

Exclusion Criteria:

  • Apnea/hypoxia index (AHI) less than 15
  • Diagnosis of another sleep disorder that causes arousals from sleep
  • Past treatment for OSA
  • Current substance abuse problem
  • Diagnosis of a serious medical condition that would interfere with involvement in the study
  • History of a major psychiatric disorder, other than depression
  • Change in antidepressant medication in the 3 months before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Active Comparator: Motivational Enhancement Therapy
MET will involve counseling sessions and phone calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns based on CPAP adherence monitoring.
Behavioral: Motivational Enhancement Therapy
Active Comparator: Educational Counseling
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
Behavioral: Educational Counseling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL067209 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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