Sleep Health Education and Social Support Among Blacks With OSA
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|ClinicalTrials.gov Identifier: NCT02628977|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Behavioral: Peer Based Sleep Health Education and Social Support Behavioral: Attention Control Group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1092 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
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.
- 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.
- Rate of Obstructive Sleep Apnea among black men and women at the community level [ Time Frame: 12 Months ]Obstructive Sleep Apnea among minorities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628977
|United States, New York|
|180 Madison Ave|
|New York, New York, United States, 10016|
|Principal Investigator:||Girardin Jean Louis, MD||New York University Medical School|