Sleep Health Education and Social Support Among Blacks With OSA

NYU Langone Health

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Peer Based Sleep Health Education and Social Support; Behavioral: Attention Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02628977

14-01028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,092 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,092 participants in 2 patient groups

OSA Health Education & Support Group

Experimental group

Description:

Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.

Treatment:

Behavioral: Peer Based Sleep Health Education and Social Support

Attention Control Group

Active Comparator group

Description:

Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.

Treatment:

Behavioral: Attention Control Group