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

NCT00939601 | Completed

• 1 other identifier: R01HL067209
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adherence to CPAP in Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; OSA; Adherence; CPAP; Cognition

Study Arms (3)

Motivational Enhancement Therapy

ACTIVE COMPARATOR

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

Educational Counseling

ACTIVE COMPARATOR

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

Behavioral: Educational Counseling

Standard Care

NO INTERVENTION

Interventions

Motivational Enhancement Therapy BEHAVIORAL

Motivational Enhancement Therapy

Educational Counseling BEHAVIORAL

Educational Counseling

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 20348198 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Last Updated: July 15, 2009

Record last verified: 2009-07