Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions - 2

Completed

• Conditions: Sleep
• Interventions: Combination Product: Assessment of sleep and related factors

• Registration Number: NCT05102188
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

The purpose of the HD-SLEEP2 study is to help researchers understand sleep in African Americans. The investigators also want to know what factors may affect sleep.

Detailed Description

African Americans who self-report poor sleep (n=80) will be invited to complete questionnaire based self-assessment of known factors and comorbidities contributing to alterations in sleep such as demographic characteristics, anthropometrics, depression, insomnia, and food habits in conjunction with objective and subjective measures of sleep via 7-day accelerometry (sleep duration), overnight oximetry (sleep apnea), and sleep questionnaires.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Study Start: 2022-03-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• Unable to provide written informed consent
• Unable to understand English

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
African American adults with poor sleep	Assessment of sleep and related factors	Individuals with self-identified poor sleep quality and/or quantity

Primary Outcome Measures

Name	Time	Method
Habitual sleep duration	7 days	Average hours of sleep/24h period
Oxygen desaturation index	1 day	Number of oxygen desaturation events per hour of sleep
Daytime Sleepiness	1 day	Severity of daytime sleepiness as determined by Epworth Sleepiness scale. The minimum score is 0 and maximum score is 24. Higher scores suggest daytime sleepiness.
Sleep Quality	1 day	Sleep quality as determined by Pittsburgh Sleep Quality Index. The minimum score is 0 and maximum score is 21. Higher scores indicate poor sleep quality.
Sleep behaviors	1 day	Sleep hygiene behaviors as determined by sleep hygiene index. The minimum score is 13 and maximum score is 65. Higher scores indicate poor sleep hygiene status.

Trial Locations

Locations (1)

Recruiting core Pennington; 🇺🇸 Baton Rouge, Louisiana, United States