Obstructive Sleep ApneaNCT02628977
Sleep Health Education and Social Support Among Blacks With OSA
A study testing Peer Based Sleep Health Education and Social Support in people with Obstructive Sleep Apnea, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Peer Based Sleep Health Education and Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,092 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 1 Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-reported race/ethnic minority
- ages ≥18 years
- accessible by telephone
- consent to participate, which includes permission to release medical record information
- A positive screening for OSA is necessary to be enrolled in the intervention protocol.
Who cannot join
- are involved in another sleep study.
- are unable to understand and sign this informed consent form.
- know someone who is participating in this study.
- had a heart attack or stroke within the past 12 weeks.
- do not identify yourself as a racial/ethnic minority.
- are pregnant.
Show all 9Show fewer
- Refuse to use the ARESTM home sleep test device.
- Refuse to use the WatchPATTM home sleep test device.
- are not at risk for sleep apnea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea
The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.
Read the detailed description
Obstructive sleep apnea (OSA), which disproportionately affects blacks (31% vs. 10%, whites), is a critical, preventable and/or treatable disease potentially causing increased cardiovascular disease (CVD) outcomes (e.g., obesity, diabetes, hypertension, stroke, arrhythmia, and chronic heart failure). Improving sleep may have direct effects in reducing CVD risk,2 enhancing brain functions, and increasing workplace productivity. Unfortunately, our focus groups suggest that most at-risk blacks are unaware of OSA symptoms or its related morbidity. Thus, it is imperative to address poor adherence among blacks with OSA, if we are to reduce health disparities associated with CVD outcomes between blacks and whites.
This is a randomized study with a total of 6 sites recruiting; 3 will serve as controls and 3 that will be intervention. Group A participants (Intervention group) will receive health education from a trained Peer Health Educator and Group B participants (Control group) will meet with a salon worker, barbershop worker, or church Health Ministry group leader. Participants will be asked to use a sleep diary and wear a home sleep test device to measure sleep for 7 days. They will be followed for 12 months.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Peer Based Sleep Health Education and Social Support, Attention Control Group
- 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.
Peer Based Sleep Health Education and Social SupportBehavioural
Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.
Attention Control GroupBehavioural
Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.
| Study group | Role | What they receive |
|---|---|---|
| OSA Health Education & Support Group | Experimental | Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator. Receives: Behavioral: Peer Based Sleep Health Education and Social Support |
| Attention Control Group | Active comparator | Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services. Receives: Behavioral: Attention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
We will perform analysis on an intention-to-treat basis.
Measured: 12 Months
Secondary outcomes (1)
Rate of Obstructive Sleep Apnea among black men and women at the community level
Obstructive Sleep Apnea among minorities.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Girardin Jean Louis, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628977
- Sponsor's protocol ID
- 14-01028
- Status last verified
- Jul 2021
- First submitted
- 8 Dec 2015
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Seixas AA, Trinh-Shevrin C, Ravenell J, Ogedegbe G, Zizi F, Jean-Louis G. Culturally tailored, peer-based sleep health education and social support to increase obstructive sleep apnea assessment and treatment adherence among a community sample of blacks: study protocol for a randomized controlled trial. Trials. 2018 Sep 24;19(1):519. doi: 10.1186/s13063-018-2835-9.
PubMed 30249293
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02628977
- Acronym / sponsor ID
- 14-01028
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Dec 2015 (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.
The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.
Detailed description
Obstructive sleep apnea (OSA), which disproportionately affects blacks (31% vs. 10%, whites), is a critical, preventable and/or treatable disease potentially causing increased cardiovascular disease (CVD) outcomes (e.g., obesity, diabetes, hypertension, stroke, arrhythmia, and chronic heart failure). Improving sleep may have direct effects in reducing CVD risk,2 enhancing brain functions, and increasing workplace productivity. Unfortunately, our focus groups suggest that most at-risk blacks are unaware of OSA symptoms or its related morbidity. Thus, it is imperative to address poor adherence among blacks with OSA, if we are to reduce health disparities associated with CVD outcomes between blacks and whites.
This is a randomized study with a total of 6 sites recruiting; 3 will serve as controls and 3 that will be intervention. Group A participants (Intervention group) will receive health education from a trained Peer Health Educator and Group B participants (Control group) will meet with a salon worker, barbershop worker, or church Health Ministry group leader. Participants will be asked to use a sleep diary and wear a home sleep test device to measure sleep for 7 days. They will be followed for 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA Health Education & Support Group | Experimental | Behavioral: Peer Based Sleep Health Education and Social SupportParticipants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator. |
| Attention Control Group | Active comparator | Behavioral: Attention Control GroupParticipants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-reported race/ethnic minority
- ages ≥18 years
- accessible by telephone
- consent to participate, which includes permission to release medical record information
- A positive screening for OSA is necessary to be enrolled in the intervention protocol.
Key exclusion criteria (9 listed)
- are involved in another sleep study.
- are unable to understand and sign this informed consent form.
- know someone who is participating in this study.
- had a heart attack or stroke within the past 12 weeks.
- do not identify yourself as a racial/ethnic minority.
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 |
|---|---|---|
| Peer Based Sleep Health Education and Social SupportParticipants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator. | Behavioural | OSA Health Education & Support Group |
| Attention Control GroupParticipants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services. | Behavioural | Attention Control Group |
Primary outcome
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
Time frame: 12 Months
We will perform analysis on an intention-to-treat basis.
1 secondary outcome
Rate of Obstructive Sleep Apnea among black men and women at the community level
Time frame: 12 Months
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 6 Jul 2021.
- Derived from this study: PubMed 30249293Seixas AA, Trinh-Shevrin C, Ravenell J, Ogedegbe G, Zizi F, Jean-Louis G. Culturally tailored, peer-based sleep health education and social support to increase obstructive sleep apnea assessment and treatment adherence among a community sample of blacks: study protocol for a randomized controlled trial. Trials. 2018 Sep 24;19(1):519. doi: 10.1186/s13063-018-2835-9.
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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.
Girardin Jean Louis, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Based Sleep Health Education and Social Support in people with Obstructive Sleep Apnea, run by NYU Langone 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 5 inclusion and 9 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 6 Jul 2021. 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?
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02628977, 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 6 Jul 2021.