Adherence to CPAP in Obstructive Sleep ApneaBREATHENCT00939601
Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea
A study testing Motivational Enhancement Therapy and Educational Counseling in people with Adherence to CPAP in Obstructive Sleep Apnea, run by Brown University.
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 25 to 85 years
- Conditions the study is for
- Adherence to CPAP in Obstructive Sleep Apnea
- What is being tested?
- Motivational Enhancement Therapy and Educational Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 25 to 85 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
- 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
About this study
Official title: Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With 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.
- Being tested
- Motivational Enhancement Therapy, Educational Counseling
- 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.
Motivational Enhancement TherapyBehavioural
Educational CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Motivational Enhancement Therapy | Active comparator | MET will involve 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. Receives: Behavioral: Motivational Enhancement Therapy |
| Educational Counseling | Active comparator | ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff. Receives: Behavioral: Educational Counseling |
| Standard Care | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adherence to CPAP in Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939601
- Sponsor's protocol ID
- R01HL067209
- Acronym
- BREATHE
- Status last verified
- Jul 2009
- First submitted
- 14 Jul 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
Publications
Aloia MS, Knoepke CE, Lee-Chiong T. The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits? Chest. 2010 Oct;138(4):875-9. doi: 10.1378/chest.09-2237. Epub 2010 Mar 26.
PubMed 20348198
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00939601
- Acronym / sponsor ID
- BREATHE / R01HL067209
- Keywords
- Obstructive Sleep Apnea, OSA, Adherence, CPAP, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Enhancement Therapy | Active comparator | Behavioral: Motivational Enhancement TherapyMET will involve 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. |
| Educational Counseling | Active comparator | Behavioral: Educational CounselingED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff. |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OSA confirmed by polysomnography (PSG)
- CPAP is the prescribed form of treatment for OSA
- Judged by sleep physician to respond to CPAP
Key exclusion criteria (7 listed)
- Apnea/hypoxia index (AHI) less than 15
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Enhancement Therapy | Behavioural | Motivational Enhancement Therapy |
| Educational Counseling | Behavioural | Educational Counseling |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
- Derived from this study: PubMed 20348198Aloia MS, Knoepke CE, Lee-Chiong T. The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits? Chest. 2010 Oct;138(4):875-9. doi: 10.1378/chest.09-2237. Epub 2010 Mar 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement Therapy and Educational Counseling in people with Adherence to CPAP in Obstructive Sleep Apnea, run by Brown University.
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 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00939601, which also lists 1 linked publication.
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 15 Jul 2009.