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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05102175
Other study ID # PBRC 2020-020-1
Secondary ID U54GM104940
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date August 24, 2022

Study information

Verified date August 2022
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the HD-SLEEP1 study is to help researchers understand what African Americans know and think about sleep. The investigators also want to know how to encourage people to participate in research studies designed to improve sleep.


Description:

African Americans (AAs) sleep worse than whites on average, thus contributing to race disparities in major health outcomes. However, contributors to poorer sleep and effective interventions to improve sleep among AAs is lacking due to under-representation of AAs in sleep research. The investigators propose to address this knowledge gap through engagement with the Baton Rouge African American community. The investigators will use focus groups to determine sleep-related perceptions as well as barriers to sleep research recruitment and retention. In this study, up to 60 African Americans who self-report poor sleep will be invited to participate in focus group discussions to understand 1) sleep related perceptions; 2) factors influencing participation; and 3) willingness to undertake study procedures typical of sleep research studies such as increasing sleep duration, diagnosing and treating OSA; along with other routine research procedures including blood draws, caloric restriction, and body composition exams.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 24, 2022
Est. primary completion date August 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Self-identified African American - Age range: >18 years (inclusive) - Sex: Both males and females will be allowed to participate in the study - Self-perceived poor sleep - Willing to be audio and video recorded Exclusion Criteria: - Unable to provide written informed consent - Unable to understand English

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Focus Group
Eligible participants will be invited to a semi-structured focus group discussion. Each group will include 8 -12 participants.

Locations

Country Name City State
United States Recruiting core Pennington Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Importance of Sleep Identify if sleep is considered important for health 1 day
Primary Knowledge related to components of good sleep Identify adequate sleep duration, good sleep quality, and absence of sleep disorders as important. 1 day
Primary Perceived advantages related to participating in sleep-related May improve health and quality of life 1 day
Primary Identify what challenges prevents participation in sleep-related research Willingness to undertake sleep related study procedures and time commitment 1 day
Primary Identify facilitators to participation in sleep research At-home assessments, study location, number of study visits 1 day
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