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

NCT00623246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2020-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Sleep Apnea, Obstructive
  • Continuous Positive Airway Pressure

Interventions

BEHAVIORAL

MET

MET will involve motivational 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

ED

ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • National Center for Research Resources (NCRR)

    collaborator NIH
  • The Miriam Hospital

    collaborator OTHER
  • National Jewish Health

    lead OTHER

Principal Investigators

  • Mark S. Aloia, PhD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00623246 on ClinicalTrials.gov