Clinical trial NCT02628977: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
timeFrame: 12 Months
Secondary outcomes:
measure: Rate of Obstructive Sleep Apnea among black men and women at the community level
timeFrame: 12 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: 180 Madison Ave
state: New York
Study officials:
affiliation: New York University Medical School
name: Girardin Jean Louis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.