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Sleep Health Education and Social Support Among Blacks With OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02628977
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Rate of Obstructive Sleep Apnea among black men and women at the community level [ Time Frame: 12 Months ]
    Obstructive Sleep Apnea among minorities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, New York
180 Madison Ave
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Girardin Jean Louis, MD New York University Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02628977    
Obsolete Identifiers: NCT02427815
Other Study ID Numbers: 14-01028
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases