SleepHD-SLEEP2NCT05102188
Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions - 2
An observational study of Sleep, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Assessment of sleep and related factors
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African Americans residing in Greater Baton Rouge area will be invited to participate in the study.
Who may be able to join
- 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
Who cannot join
- Unable to provide written informed consent
- Unable to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Recruiting core Pennington
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Assessment of sleep and related factors
- Keywords
- African American, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sleep and related factorsCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| African American adults with poor sleep | Individuals with self-identified poor sleep quality and/or quantity Receives: Combination Product: Assessment of sleep and related factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual sleep duration
Average hours of sleep/24h period
Measured: 7 days
Oxygen desaturation index
Number of oxygen desaturation events per hour of sleep
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start11 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Prachi Singh, Pennington Biomedical Research Center
- Investigators
- Prachi Singh, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102188
- Sponsor's protocol ID
- PBRC 2020-020-2
- Other IDs
- U54GM104940
- Acronym
- HD-SLEEP2
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions -2
- ClinicalTrials.gov ID
- NCT05102188
- Acronym / sponsor ID
- HD-SLEEP2 / PBRC 2020-020-2
- Conditions
- Sleep
- Keywords
- African American, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African American adults with poor sleep | – | Combination Product: Assessment of sleep and related factorsIndividuals with self-identified poor sleep quality and/or quantity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African Americans residing in Greater Baton Rouge area will be invited to participate in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide written informed consent
- Unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of sleep and related factorsEligible 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. | Combination product | African American adults with poor sleep |
Primary outcome
Habitual sleep duration
Time frame: 7 days
Average hours of sleep/24h period
Oxygen desaturation index
Time frame: 1 day
Number of oxygen desaturation events per hour of sleep
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prachi Singh, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habitual sleep duration (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.