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

This study has been completed.
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT00939601
First received: July 14, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Adherence to CPAP in Obstructive Sleep Apnea
 Behavioral: Motivational Enhancement Therapy
Behavioral: Educational Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Brown University:

Arms Assigned Interventions
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
No Intervention: Standard Care

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Brown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mark S. Aloia, PhD,, National Jewish Health
ClinicalTrials.gov Identifier: NCT00939601     History of Changes
Other Study ID Numbers: R01HL67209
Study First Received: July 14, 2009
Last Updated: July 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Obstructive Sleep Apnea
OSA
Adherence
CPAP
Cognition

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013