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Completed

NCT Number: NCT05102188

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.

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Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Recruiting core Pennington

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of sleep and related factors

Combination Product

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.

Primary outcomes

  1. Habitual sleep duration

    Time frame: 7 days

    Average hours of sleep/24h period

  2. Oxygen desaturation index

    Time frame: 1 day

    Number of oxygen desaturation events per hour of sleep

  3. Sleep Quality

    Time frame: 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.

  4. Daytime Sleepiness

    Time frame: 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.

  5. Sleep behaviors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Acronym: HD-SLEEP2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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