Sleep Health Education and Social Support Among Blacks With OSA

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02628977

Collaborator

(none)

1,092

Enrollment

Location

Arms

Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Behavioral: Peer Based Sleep Health Education and Social Support Behavioral: Attention Control Group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1092 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OSA Health Education & Support Group Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.	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.
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: OSA Health Education & Support Group

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

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.

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

Rate of Obstructive Sleep Apnea among black men and women at the community level [12 Months]
Obstructive Sleep Apnea among minorities.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	180 Madison Ave	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Girardin Jean Louis, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02628977

Other Study ID Numbers:

14-01028
NCT02427815

First Posted:

Dec 11, 2015

Last Update Posted:

Jul 6, 2021

Last Verified:

Jul 1, 2021

Additional relevant MeSH terms:

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Jul 6, 2021