Sleep Health Education and Social Support Among Blacks With OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628977
• Other study ID #: 14-01028
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02427815

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1092
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Peer Based Sleep Health Education and Social Support
Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.
• Attention Control Group
Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.

Locations

Country	Name	City	State
United States	180 Madison Ave	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Obstructive Sleep Apnea among black men and women at the community level	Obstructive Sleep Apnea among minorities.	12 Months