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Sleep Apnea, ObstructiveBREATHENCT00623246

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

A study testing MET and ED in people with Sleep Apnea, Obstructive and Continuous Positive Airway Pressure, run by National Jewish Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
MET and ED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
1 siteUnited States
Study dates
Dec 2007to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • OSA confirmed by polysomnography (PSG)
  • CPAP is the prescribed form of treatment for OSA
  • Judged by sleep physician to respond to CPAP

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

Other trials in United States

About this study

Official title: Motivating Adherence to CPAP in Obstructive Sleep Apnea

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.

Read the 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.

Being tested
MET, ED
Keywords
Obstructive Sleep Apnea, OSA, Adherence, CPAP, Cognition
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • METBehavioural

    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.

  • EDBehavioural

    ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.

Study groups in NCT00623246
Study groupRoleWhat they receive
1Active comparatorParticipants will receive motivational enhancement therapy (MET) for 12 weeks.
Receives: Behavioral: MET
2Active comparatorParticipants will receive educational therapy (ED) for 12 weeks.
Receives: Behavioral: ED
3No interventionParticipants will receive standard clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to CPAP

    Measured: Measured at Months 3, 6, and 12

  2. Cognitive function

    Measured: Measured at Months 3, 6, and 12

  3. Subjective sleepiness

    Measured: Measured at Months 3, 6, and 12

  4. Quality of life

    Measured: Measured at Months 3, 6, and 12

Secondary outcomes (3)
  1. Blood pressure

    Measured: Measured at Months 3, 6, and 12

  2. Cytokines and inflammatory markers

    Measured: Measured at Month 3

  3. Attitudes toward CPAP use (transtheoretical model [TTM] and social cognitive theory [SCT] model variables)

    Measured: Measured at Months 3, 6, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionNov 2012
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623246
Sponsor's protocol ID
560
Other IDs
R01HL067209, 2R01HL067209
Acronym
BREATHE
Status last verified
Oct 2020
First submitted
7 Jan 2008
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MET and ED in people with Sleep Apnea, Obstructive and Continuous Positive Airway Pressure, run by National Jewish Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to CPAP (time frame: Measured at Months 3, 6, and 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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