Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea (The BREATHE Study)
Condition: Sleep Apnea, Obstructive; Continuous Positive Airway Pressure
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

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.
    

Intervention name(s): MET; ED
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; OSA; Adherence; CPAP; Cognition