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

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05102188

Collaborator

National Institute of General Medical Sciences (NIGMS) (NIH)

Enrollment

Location

9.7

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 11, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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
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.
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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Recruiting core Pennington	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

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

Investigators

Principal Investigator: Prachi Singh, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prachi Singh, Associate Professor, Sleep and Cardiometabolic Health, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT05102188

Other Study ID Numbers:

PBRC 2020-020-2
U54GM104940

First Posted:

Nov 1, 2021

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prachi Singh, Associate Professor, Sleep and Cardiometabolic Health, Pennington Biomedical Research Center

African American

Sleep

Study Results

No Results Posted as of Mar 15, 2022