Sleep Health Education and Social Support Among Blacks With OSA

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Attention Control Group; Behavioral: Peer Based Sleep Health Education and Social Support

• Registration Number: NCT02628977
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1092

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control Group	Attention Control Group	Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.
OSA Health Education & Support Group	Peer Based Sleep Health Education and Social Support	Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.

Primary Outcome Measures

Name	Time	Method
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure	12 Months	We will perform analysis on an intention-to-treat basis.

Secondary Outcome Measures

Name	Time	Method
Rate of Obstructive Sleep Apnea among black men and women at the community level	12 Months	Obstructive Sleep Apnea among minorities.

Trial Locations

Locations (1)

180 Madison Ave; 🇺🇸 New York, New York, United States