Back to resultsEvaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea (BREATHE)
Primary Purpose
Adherence to CPAP in Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Enhancement Therapy
Educational Counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Adherence to CPAP in Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, OSA, Adherence, CPAP, Cognition
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Motivational Enhancement Therapy
Educational Counseling
Standard Care
Arm Description
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.
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00939601
First Posted
July 14, 2009
Last Updated
July 14, 2009
Sponsor
Brown University
Collaborators
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00939601
Brief Title
Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea
Acronym
BREATHE
Official Title
Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Brown University
Collaborators
Rhode Island Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence to CPAP in Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, OSA, Adherence, CPAP, Cognition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Motivational Enhancement Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Educational Counseling
Arm Type
Active Comparator
Arm Description
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
Arm Title
Standard Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Type
Behavioral
Intervention Name(s)
Educational Counseling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
20348198
Citation
Aloia MS, Knoepke CE, Lee-Chiong T. The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits? Chest. 2010 Oct;138(4):875-9. doi: 10.1378/chest.09-2237. Epub 2010 Mar 26.
Results Reference
derived
Learn more about this trial
Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea
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