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

This study is currently recruiting participants.
Verified April 2014 by National Jewish Health
Sponsor:
Collaborators:
The Miriam Hospital
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT00623246
First received: January 7, 2008
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Sleep Apnea, Obstructive
Continuous Positive Airway Pressure
Behavioral: MET
Behavioral: ED

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motivating Adherence to CPAP in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Adherence to CPAP [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Subjective sleepiness [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Cytokines and inflammatory markers [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Attitudes toward CPAP use (transtheoretical model [TTM] and social cognitive theory [SCT] model variables) [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623246

Contacts
Contact: Mark S. Aloia, PhD 303-270-2386 aloiam@njc.org
Contact: Jessica Asherin 303-398-1793 asherinj@njc.org

Locations
United States, Colorado
National Jewish Medical and Research Center Recruiting
Denver, Colorado, United States, 80206
Contact: Mark S. Aloia, PhD    303-270-2386    aloiam@njc.org   
Contact: Jessica Asherin    303-398-1793    asherinj@njc.org   
Principal Investigator: Mark S. Aloia, PhD         
Sub-Investigator: Fred Wamboldt, MD         
Sub-Investigator: Teofilo Lee-Chiong, MD         
Sponsors and Collaborators
National Jewish Health
The Miriam Hospital
Investigators
Principal Investigator: Mark S. Aloia, PhD National Jewish Health
  More Information

No publications provided

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT00623246     History of Changes
Other Study ID Numbers: 560, R01HL067209, 2 R01 HL67209
Study First Received: January 7, 2008
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Jewish Health:
Obstructive Sleep Apnea
OSA
Adherence
CPAP
Cognition

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

ClinicalTrials.gov processed this record on April 17, 2014