Sleep Health Education and Social Support Among Blacks With OSA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Peer Based Sleep Health Education and Social Support
* Behavioral: Attention Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA Health Education & Support Group<br>Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator. | Behavioral: Peer Based Sleep Health Education and Social Support<br>* Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.<br>|
| Active Comparator: Attention Control Group<br>Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services. | Behavioral: Attention Control Group<br>* Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure | We will perform analysis on an intention-to-treat basis. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Obstructive Sleep Apnea among black men and women at the community level | Obstructive Sleep Apnea among minorities. | 12 Months |