Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea (The BREATHE Study)
BREATHE
Motivating Adherence to CPAP in Obstructive Sleep Apnea
3 other identifiers
interventional
306
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 22, 2020
October 1, 2020
4.9 years
January 7, 2008
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Adherence to CPAP
Measured at Months 3, 6, and 12
Cognitive function
Measured at Months 3, 6, and 12
Subjective sleepiness
Measured at Months 3, 6, and 12
Quality of life
Measured at Months 3, 6, and 12
Secondary Outcomes (3)
Blood pressure
Measured at Months 3, 6, and 12
Cytokines and inflammatory markers
Measured at Month 3
Attitudes toward CPAP use (transtheoretical model [TTM] and social cognitive theory [SCT] model variables)
Measured at Months 3, 6, and 12
Study Arms (3)
1
ACTIVE COMPARATORParticipants will receive motivational enhancement therapy (MET) for 12 weeks.
2
ACTIVE COMPARATORParticipants will receive educational therapy (ED) for 12 weeks.
3
NO INTERVENTIONParticipants will receive standard clinical care.
Interventions
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.
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
Eligibility Criteria
You may qualify if:
- OSA confirmed by polysomnography (PSG)
- CPAP is the prescribed form of treatment for OSA
- Judged by sleep physician to respond to CPAP
You may not qualify if:
- Apnea/hypoxia index (AHI) less than 15 and no daytime functional symptoms or associated cardiovascular disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- National Center for Research Resources (NCRR)collaborator
- The Miriam Hospitalcollaborator
Study Sites (1)
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S. Aloia, PhD
National Jewish Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
February 25, 2008
Study Start
December 1, 2007
Primary Completion
November 1, 2012
Study Completion
November 1, 2015
Last Updated
October 22, 2020
Record last verified: 2020-10