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

Sleep Clinical Trial

— HD-SLEEP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102188
• Other study ID #: PBRC 2020-020-2
• Secondary ID: U54GM104940
• Status: Completed
• Start date: March 11, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 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

Exclusion Criteria:

• Unable to provide written informed consent

• Unable to understand English

Related Conditions & MeSH terms

• Sleep

Intervention

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.

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	Habitual sleep duration	Average hours of sleep/24h period	7 days
Primary	Oxygen desaturation index	Number of oxygen desaturation events per hour of sleep	1 day
Primary	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
Primary	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
Primary	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