Sleep Health Education and Social Support Among Blacks With OSA
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Based Sleep Health Education and Social Support
Attention Control Group
Sponsored by
About this trial
This is an interventional prevention trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- 180 Madison Ave
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OSA Health Education & Support Group
Attention Control Group
Arm Description
Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.
Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.
Outcomes
Primary Outcome Measures
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
We will perform analysis on an intention-to-treat basis.
Secondary Outcome Measures
Rate of Obstructive Sleep Apnea among black men and women at the community level
Obstructive Sleep Apnea among minorities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02628977
Brief Title
Sleep Health Education and Social Support Among Blacks With OSA
Official Title
Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1092 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OSA Health Education & Support Group
Arm Type
Experimental
Arm Description
Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.
Arm Title
Attention Control Group
Arm Type
Active Comparator
Arm Description
Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.
Intervention Type
Behavioral
Intervention Name(s)
Peer Based Sleep Health Education and Social Support
Intervention Description
Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Group
Intervention Description
Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.
Primary Outcome Measure Information:
Title
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
Description
We will perform analysis on an intention-to-treat basis.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Rate of Obstructive Sleep Apnea among black men and women at the community level
Description
Obstructive Sleep Apnea among minorities.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girardin Jean Louis, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
180 Madison Ave
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30249293
Citation
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.
Results Reference
derived
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Sleep Health Education and Social Support Among Blacks With OSA
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