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

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ClinicalTrials.gov Identifier: NCT00623246
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Continuous Positive Airway Pressure Behavioral: MET Behavioral: ED

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motivating Adherence to CPAP in Obstructive Sleep Apnea
Study Start Date : December 2007
Primary Completion Date : November 2012
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Participants will receive motivational enhancement therapy (MET) for 12 weeks.
Behavioral: 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: 2
Participants will receive educational therapy (ED) for 12 weeks.
Behavioral: ED
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
No Intervention: 3
Participants will receive standard clinical care.

Outcome Measures

Primary Outcome Measures :
  1. Adherence to CPAP [ Time Frame: Measured at Months 3, 6, and 12 ]
  2. Cognitive function [ Time Frame: Measured at Months 3, 6, and 12 ]
  3. Subjective sleepiness [ Time Frame: Measured at Months 3, 6, and 12 ]
  4. Quality of life [ Time Frame: Measured at Months 3, 6, and 12 ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Measured at Months 3, 6, and 12 ]
  2. Cytokines and inflammatory markers [ Time Frame: Measured at Month 3 ]
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623246

United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
The Miriam Hospital
Principal Investigator: Mark S. Aloia, PhD National Jewish Health
More Information

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT00623246     History of Changes
Other Study ID Numbers: 560
R01HL067209 ( U.S. NIH Grant/Contract )
2R01HL067209 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: December 2014

Keywords provided by Jennifer Brandorff, National Jewish Health:
Obstructive Sleep Apnea

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases