Overview

This trial is active, not recruiting.

Conditions sleep apnea, obstructive, continuous positive airway pressure
Treatments met, ed
Sponsor National Jewish Health
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date December 2007
End date August 2015
Trial size 300 participants
Trial identifier NCT00623246, 2 R01 HL67209, 560, R01HL067209

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants will receive motivational enhancement therapy (MET) for 12 weeks.
met
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.
(Active Comparator)
Participants will receive educational therapy (ED) for 12 weeks.
ed
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
(No Intervention)
Participants will receive standard clinical care.

Primary Outcomes

Measure
Adherence to CPAP
time frame: Measured at Months 3, 6, and 12
Cognitive function
time frame: Measured at Months 3, 6, and 12
Subjective sleepiness
time frame: Measured at Months 3, 6, and 12
Quality of life
time frame: Measured at Months 3, 6, and 12

Secondary Outcomes

Measure
Blood pressure
time frame: Measured at Months 3, 6, and 12
Cytokines and inflammatory markers
time frame: Measured at Month 3
Attitudes toward CPAP use (transtheoretical model [TTM] and social cognitive theory [SCT] model variables)
time frame: Measured at Months 3, 6, and 12

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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 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

Additional Information

Official title Motivating Adherence to CPAP in Obstructive Sleep Apnea
Principal investigator Mark S. Aloia, PhD
Description OSA is a common sleep disorder that is characterized by a brief collapse and blockage of the upper airway during sleep. This blockage prevents air from flowing properly into the lungs and causes pauses in breathing. Symptoms include loud snoring, choking or gasping during sleep, and abnormal daytime sleepiness. If left untreated, OSA can lead to heart disease, high blood pressure, and stroke. The most common treatment for OSA is CPAP therapy, in which a mask is worn over the nose during sleep and pressurized air flows through the mask to keep the throat open. Unfortunately, CPAP treatment adherence is often poor. Previous research studies showed that people receiving motivational enhancement therapy (MET) or educational therapy (ED) adhered better to CPAP treatment than did people not receiving MET or ED therapy. However, even for people who received MET or ED, adherence usually diminished after 12 months. It appears that patterns of treatment adherence are often set early and people who maintain adherence within the first week of treatment have a greater chance of maintaining long-term adherence. Using enhanced, more intense versions of MET and ED that are delivered when CPAP therapy begins, this study will evaluate the effectiveness of MET and ED at improving CPAP treatment adherence in people with OSA. This study will enroll people with OSA. Participants will be randomly assigned to a 12-week MET group, a 12-week ED group, or a standard clinical care group, with all treatments beginning at the time participants start CPAP therapy. All participants will attend a baseline study visit to undergo weight and blood pressure measurements; assessments of cognitive functioning, mood, daytime sleepiness, functional outcomes, and attitudes toward therapy; and an optional blood collection. At baseline and Week 1, participants in the MET and ED groups will take part in two 45-minute, face-to-face counseling sessions. During these sessions, participants in the MET group will receive motivational counseling from study staff, and participants in the ED group will receive educational information about OSA from study staff. At Months 1 and 3, participants will receive two phone calls from study staff. The MET group will receive motivational counseling during these calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns. The ED group will receive educational information and feedback on problem-solving and adherence during the calls. Throughout the study, all participants will have their CPAP adherence electronically monitored on a daily basis. Participants who fail to meet the minimum standard of CPAP adherence will receive up to four additional phone calls during the study. At Months 3, 6, and 12, all participants will attend study visits for repeat baseline measurements.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by National Jewish Health.