SleepHD-SLEEP1NCT05102175
Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions
An observational study of Sleep, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of the HD-SLEEP1 study is to help researchers understand what African Americans know and think about sleep. The investigators also want to know how to encourage people to participate in research studies designed to improve 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?
- Focus Group
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 24 Aug 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
- Willing to be audio and video recorded
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
The purpose of the HD-SLEEP1 study is to help researchers understand what African Americans know and think about sleep. The investigators also want to know how to encourage people to participate in research studies designed to improve sleep.
Read the detailed description
African Americans (AAs) sleep worse than whites on average, thus contributing to race disparities in major health outcomes. However, contributors to poorer sleep and effective interventions to improve sleep among AAs is lacking due to under-representation of AAs in sleep research. The investigators propose to address this knowledge gap through engagement with the Baton Rouge African American community. The investigators will use focus groups to determine sleep-related perceptions as well as barriers to sleep research recruitment and retention.
In this study, up to 60 African Americans who self-report poor sleep will be invited to participate in focus group discussions to understand 1) sleep related perceptions; 2) factors influencing participation; and 3) willingness to undertake study procedures typical of sleep research studies such as increasing sleep duration, diagnosing and treating OSA; along with other routine research procedures including blood draws, caloric restriction, and body composition exams.
- Conditions
- Sleep
- Being tested
- Focus Group
- Keywords
- African American, Sleep, Research Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Eligible participants will be invited to a semi-structured focus group discussion. Each group will include 8 -12 participants.
| Study group | Role | What they receive |
|---|---|---|
| African American adults with poor sleep | Individuals with self-identified poor sleep quality and/or quantity Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Importance of Sleep
Identify if sleep is considered important for health
Measured: 1 day
Knowledge related to components of good sleep
Identify adequate sleep duration, good sleep quality, and absence of sleep disorders as important.
Measured: 1 day
Perceived advantages related to participating in sleep-related
May improve health and quality of life
Measured: 1 day
Identify what challenges prevents participation in sleep-related research
Willingness to undertake sleep related study procedures and time commitment
Measured: 1 day
Identify facilitators to participation in sleep research
At-home assessments, study location, number of study visits
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 start1 Nov 2021
- Primary completion24 Aug 2022
- Study completion24 Aug 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
- 36 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
- NCT05102175
- Sponsor's protocol ID
- PBRC 2020-020-1
- Other IDs
- U54GM104940
- Acronym
- HD-SLEEP1
- Status last verified
- Aug 2022
- First submitted
- 20 Oct 2021
- Last updated
- 29 Aug 2022
- 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 29 Aug 2022. 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
- ClinicalTrials.gov ID
- NCT05102175
- Acronym / sponsor ID
- HD-SLEEP1 / PBRC 2020-020-1
- Conditions
- Sleep
- Keywords
- African American, Sleep, Research Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 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-SLEEP1 study is to help researchers understand what African Americans know and think about sleep. The investigators also want to know how to encourage people to participate in research studies designed to improve sleep.
Detailed description
African Americans (AAs) sleep worse than whites on average, thus contributing to race disparities in major health outcomes. However, contributors to poorer sleep and effective interventions to improve sleep among AAs is lacking due to under-representation of AAs in sleep research. The investigators propose to address this knowledge gap through engagement with the Baton Rouge African American community. The investigators will use focus groups to determine sleep-related perceptions as well as barriers to sleep research recruitment and retention.
In this study, up to 60 African Americans who self-report poor sleep will be invited to participate in focus group discussions to understand 1) sleep related perceptions; 2) factors influencing participation; and 3) willingness to undertake study procedures typical of sleep research studies such as increasing sleep duration, diagnosing and treating OSA; along with other routine research procedures including blood draws, caloric restriction, and body composition exams.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African American adults with poor sleep | – | Other: Focus GroupIndividuals 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 (5 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
- Willing to be audio and video recorded
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 |
|---|---|---|
| Focus GroupEligible participants will be invited to a semi-structured focus group discussion. Each group will include 8 -12 participants. | Other | African American adults with poor sleep |
Primary outcome
Importance of Sleep
Time frame: 1 day
Identify if sleep is considered important for health
Knowledge related to components of good sleep
Time frame: 1 day
Identify adequate sleep duration, good sleep quality, and absence of sleep disorders as important.
Perceived advantages related to participating in sleep-related
Time frame: 1 day
May improve health and quality of life
Identify what challenges prevents participation in sleep-related research
Time frame: 1 day
Willingness to undertake sleep related study procedures and time commitment
Identify facilitators to participation in sleep research
Time frame: 1 day
At-home assessments, study location, number of study visits
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 29 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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 5 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 29 Aug 2022. 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?
Importance of Sleep (time frame: 1 day). 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 29 Aug 2022.