NCT05102188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

October 20, 2021

Last Update Submit

February 3, 2023

Conditions

Keywords

African AmericanSleep

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

African American adults with poor sleep

Individuals with self-identified poor sleep quality and/or quantity

Combination Product: Assessment of sleep and related factors

Interventions

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.

African American adults with poor sleep

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recruiting core Pennington

Baton Rouge, Louisiana, 70808, United States

Location

Study Officials

  • Prachi Singh, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Sleep and Cardiometabolic Health

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 1, 2021

Study Start

March 11, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations