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OpenTrials
Completed

NCT Number: NCT02628977

Sleep Health Education and Social Support Among Blacks With OSA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

180 Madison Ave

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer Based Sleep Health Education and Social Support

Behavioral

Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.

Attention Control Group

Behavioral

Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of Obstructive Sleep Apnea among black men and women at the community level

    Time frame: 12 Months

    Obstructive Sleep Apnea among minorities.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2015
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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