Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions - 2 (HD-SLEEP2)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Combination product: Assessment of sleep and related factors

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting core Pennington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

African Americans residing in Greater Baton Rouge area will be invited to participate in the study.

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

African American adults with poor sleep; Individuals with self-identified poor sleep quality and/or quantity

Combination product: Assessment of sleep and related factors; Eligible participants will be invited to fill out several forms and wear a watch-like device on their wrist (an accelerometer) for 7 days to assess their sleep habits. They will also be asked to sleep at home with a watch-like device attached to a sleeve which covers their index finger (an oximeter) for one night to assess whether they may have a sleep problem like sleep apnea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habitual sleep duration	Average hours of sleep/24h period	7 days
Oxygen desaturation index	Number of oxygen desaturation events per hour of sleep	1 day
Sleep Quality	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.	1 day
Daytime Sleepiness	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.	1 day
Sleep behaviors	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.	1 day

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2022
• Primary Completion (ACTUAL): December 31, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): November 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; African American
• Other Study ID Numbers: PBRC 2020-020-2; U54GM104940 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No