Sleep Apnea, ObstructiveNCT02538419
Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
A study testing CPAP + Peer Support and CPAP + Individual Education in people with Sleep Apnea, Obstructive, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP + Peer Support and CPAP + Individual Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with obstructive sleep apnea (no cut-off for severity)
- Prescribed continuous positive airway pressure
Who cannot join
- Not fluent in English
- Prior CPAP use at home
- Current use of any non-CPAP treatment for obstructive sleep apnea
- A co-morbid sleep disorder
- Use of supplemental oxygen
- A clinical need for urgent CPAP therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education.
Read the detailed description
The study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). Participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning CPAP and the other occurring two weeks later. Participants in the individual education (comparator) arm will begin CPAP without attendance at any peer-support sessions.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP + Peer Support, CPAP + Individual Education
- 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.
CPAP + Peer SupportBehavioural
CPAP + Individual EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CPAP + Peer Support | Active comparator | Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
All participants will receive CPAP in addition to this intervention. Receives: Behavioral: CPAP + Peer Support |
| CPAP + Individual Education | Active comparator | Participants randomized to this arm will receive individual support and education from a trained investigator.
All participants will receive CPAP in addition to this intervention. Receives: Behavioral: CPAP + Individual Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Objective adherence to CPAP, measured in hours per night.
Measured: 6 weeks
Secondary outcomes (5)
Percentage of Participants With Adherence >=4 Hours/Night on Average
Objective adherence to CPAP, percentage with adherence >=4 hours/night on average
Measured: 6 weeks
FOSQ
Functional Outcomes of Sleep Questionnaire. The FOSQ is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep.
Measured: 6 weeks
SEMSA - Perceived Risk
Self Efficacy Measure for Sleep Apnea - Perceived Risk The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of perceived risk associated with sleep apnea.
Measured: 6 weeks
SEMSA - Outcome Expectations
Self Efficacy Measure for Sleep Apnea - Outcome Expectations. The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of outcome expectations associated with treatment of sleep apnea.
Measured: 6 weeks
SEMSA - Self Efficacy
Self Efficacy Measure for Sleep Apnea - Self Efficacy The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of self efficacy associated with treatment of sleep apnea.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Redline, Brigham and Women's Hospital
- Investigators
- Susan Redline, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538419
- Sponsor's protocol ID
- 2014P002326
- Status last verified
- Mar 2019
- First submitted
- 31 Aug 2015
- Last updated
- 21 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
- ClinicalTrials.gov ID
- NCT02538419
- Acronym / sponsor ID
- 2014P002326
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education.
Detailed description
The study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). Participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning CPAP and the other occurring two weeks later. Participants in the individual education (comparator) arm will begin CPAP without attendance at any peer-support sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP + Peer Support | Active comparator | Behavioral: CPAP + Peer SupportParticipants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study. All participants will receive CPAP in addition to this intervention. |
| CPAP + Individual Education | Active comparator | Behavioral: CPAP + Individual EducationParticipants randomized to this arm will receive individual support and education from a trained investigator. All participants will receive CPAP in addition to this intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with obstructive sleep apnea (no cut-off for severity)
- Prescribed continuous positive airway pressure
Key exclusion criteria (6 listed)
- Not fluent in English
- Prior CPAP use at home
- Current use of any non-CPAP treatment for obstructive sleep apnea
- A co-morbid sleep disorder
- Use of supplemental oxygen
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 |
|---|---|---|
| CPAP + Peer Support | Behavioural | CPAP + Peer Support |
| CPAP + Individual Education | Behavioural | CPAP + Individual Education |
Primary outcome
Adherence
Time frame: 6 weeks
Objective adherence to CPAP, measured in hours per night.
5 secondary outcomes
Percentage of Participants With Adherence >=4 Hours/Night on Average
Time frame: 6 weeks
FOSQ
Time frame: 6 weeks
SEMSA - Perceived Risk
Time frame: 6 weeks
SEMSA - Outcome Expectations
Time frame: 6 weeks
SEMSA - Self Efficacy
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Susan Redline, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP + Peer Support and CPAP + Individual Education in people with Sleep Apnea, Obstructive, run by Brigham and Women's Hospital 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 2 inclusion and 6 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 21 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 6 weeks). 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 21 Mar 2019.