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

NCT ID: NCT00939601

Last Updated: 2009-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Adherence to CPAP in Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Motivational Enhancement Therapy

Intervention Type BEHAVIORAL

Educational Counseling

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

Group Type ACTIVE_COMPARATOR

Educational Counseling

Intervention Type BEHAVIORAL

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational Enhancement Therapy

Intervention Type BEHAVIORAL

Educational Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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National Jewish Health

References

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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.

Reference Type DERIVED
PMID: 20348198 (View on PubMed)

Other Identifiers

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R01HL067209

Identifier Type: NIH

Identifier Source: org_study_id

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