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

Adherence to CPAP in Obstructive Sleep Apnea Clinical Trial

— BREATHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939601
• Other study ID #: R01HL067209
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: July 14, 2009

Study information

• Verified date: July 2009
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adherence to CPAP in Obstructive Sleep Apnea
• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Motivational Enhancement Therapy

• Educational Counseling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Rhode Island Hospital