Sleep ApneaNCT06336525
Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.
An observational study of Sleep Apnea and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Sleep Apnea, Insomnia, Sleep Deprivation
- How many people
- 3,680 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will consist of a general population sample of adults age 25-64 years residing in 10 counties in the rural Appalachia and Mississippi Delta regions (AMD): Alabama, Mississippi, Louisiana, and Kentucky, with counties sampled proportional to their populations. The projected RURAL Study sample size is 4600 individuals, with approximately equal numbers in each of the four age deciles. The sample is anticipated to include 51.7% women and 48.3% men. The projected racial/ethnic make-up of the sample is 63.8% non-Hispanic white, 32.7% non-Hispanic black, 1.7% Hispanic and 1.8% other.
Who may be able to join
- All participants in the Risk Underlying Rural Areas Longitudinal (RURAL) Study will be eligible for enrollment in this ancillary study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Sleep Health in the Rural South and Its Relationships With Cardiometabolic Health Disparities
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.
Read the detailed description
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. Growing evidence implicates poor sleep health as an important risk factor for cardiometabolic disease. While this is most well established for sleep apnea and insomnia, there is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, also affect cardiometabolic disease risk. Moreover, rural Southern communities are likely to experience high rates of impaired sleep health, reflecting high levels of psychosocial and environmental stressors, such as financial stress, social isolation, environmental pollution, and poor built environment in addition to high rates of smoking and obesity. However, there is currently a lack of systematically developed sleep data in rural populations.
Recognizing the paucity of research on cardiometabolic risk in this high-risk rural population, the NHLBI recently initiated a new longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study) to identify the complex individual, social and environmental factors contributing to this high burden of disease. The proposed RURAL Sleep Study will complement the RURAL Study by incorporating minimally burdensome measures of multiple dimensions of sleep health at the time of baseline cohort assessment in approximately 4000 adults age 25-64 years, utilizing mobile health technologies to
- measure sleep apnea over seven consecutive nights;
- measure sleep duration, timing, regularity and fragmentation over multiple weeks; and
- administer standardized questionnaires to assess insomnia, chronotype, sleep quality, sleep-related impairment, and fatigue.
These data will allow us to leverage the planned extensive assessments of cardiometabolic risk factors, subclinical disease, and psychosocial and environmental stressors (and resilience factors) to address the following specific aims:
Aim 1a. Quantify population distributions of sleep health measures in a rural cohort along dimensions of sleep apnea, insomnia, chronotype, and sleep duration, efficiency, timing, and regularity.
Aim 1b. Identify psychosocial, behavioral, and environmental correlates of sleep health in rural communities.
Aim 2. Assess the association of sleep health with cardiometabolic risk factors and subclinical cardiovascular disease independent of other established cardiovascular and metabolic risk factors.
The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.
- Conditions
- Sleep Apnea, Insomnia, Sleep Deprivation, Sleep Disorders, Circadian Rhythm, Sleepiness, Excessive Daytime, Fatigue
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Sleep Disorders, Circadian Rhythm, Disorders of Excessive Somnolence, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation index
Frequency of 4% drops in nocturnal blood oxygen saturation
Measured: 7 nights
Insomnia Severity Index
min: 0, max: 28, higher score indicates more insomnia symptoms
Measured: Single measurement at baseline
Sleep Duration
Mean total sleep time from accelerometry
Measured: 3-6 months
Sleep Duration Regularity
Variability in total sleep time from accelerometry
Measured: 3-6 months
Sleep Timing
Sleep midpoint from accelerometry
Measured: 3-6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a
raw score min: 8, max: 40; higher score indicates greater impairment
Measured: Single measurement at baseline
Secondary outcomes (5)
Restless Legs Syndrome (RLS)
Restless Legs Syndrome, yes/no
Measured: Single measurement at baseline
Chronotype
Body's natural tendency to go to sleep and wake up at certain times
Measured: Single measurement at baseline
Sleep Timing Regularity
Variability in sleep midpoint from accelerometry
Measured: 7 days
Global Sleep Quality
Pittsburgh Sleep Quality Index (PSQI), min: 0, Max: 21; higher score indicates poorer sleep quality Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL < 5 associated with good sleep quality TOTAL > 5 associated with poor sleep quality
Measured: Single measurement at baseline
Oxygen desaturation index, 3%
Frequency of 3% drops in nocturnal blood oxygen saturation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start8 May 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 3,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Emory University, University of Pennsylvania, University of Massachusetts, Worcester, The University of Texas Health Science Center at San Antonio, Beth Israel Deaconess Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daniel J.Gottlieb, M.D.,M.P.H., Brigham and Women's Hospital
- Investigators
- Daniel J Gottlieb, MD, MPH, Principal investigator, Brigham and Women's HospitalTené Lewis, PhD, Principal investigator, Emory UniversityTianyi Huang, PhD, Principal investigator, Harvard Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336525
- Sponsor's protocol ID
- 2023P001895
- Other IDs
- R01HL164462
- Status last verified
- Oct 2025
- First submitted
- 22 Mar 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified oximetry data and the results of sleep questionnaires will be shared via the National Sleep Research Resource (NSRR) (sleepdata.org). The RURAL sleep data will be available for any researcher who provides an acceptable Data Access and Use Agreement and has appropriate regulatory approvals. The NSRR has procedures to streamline Institutional Review Board (IRB) approval (via an in house IRB process). The NSRR is in the process of migrating to Bio Data Catalyst, enabling easy linkage and interoperability with other Bio Data Catalyst data (from RURAL) and other cohorts to individuals with approved Database of Genotypes and Phenotypes (dbGaP) authorization. Other RURAL Study data that are integral to this project but were collected separately by the parent RURAL Study (e.g., non-sleep cardiovascular risk and outcomes data) will be distributed via RURAL Study data sharing mechanisms, including via Bio Data Catalyst and dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Health in the Rural South and Its Relationships With Cardiometabolic Health Disparities
- ClinicalTrials.gov ID
- NCT06336525
- Acronym / sponsor ID
- 2023P001895
- Conditions
- Sleep Apnea, Insomnia, Sleep Deprivation, Sleep Disorders, Circadian Rhythm, Sleepiness, Excessive Daytime, Fatigue
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,680 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Emory University, University of Pennsylvania, University of Massachusetts, Worcester, The University of Texas Health Science Center at San Antonio, Beth Israel Deaconess Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Mar 2024 (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.
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.
Detailed description
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. Growing evidence implicates poor sleep health as an important risk factor for cardiometabolic disease. While this is most well established for sleep apnea and insomnia, there is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, also affect cardiometabolic disease risk. Moreover, rural Southern communities are likely to experience high rates of impaired sleep health, reflecting high levels of psychosocial and environmental stressors, such as financial stress, social isolation, environmental pollution, and poor built environment in addition to high rates of smoking and obesity. However, there is currently a lack of systematically developed sleep data in rural populations.
Recognizing the paucity of research on cardiometabolic risk in this high-risk rural population, the NHLBI recently initiated a new longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study) to identify the complex individual, social and environmental factors contributing to this high burden of disease. The proposed RURAL Sleep Study will complement the RURAL Study by incorporating minimally burdensome measures of multiple dimensions of sleep health at the time of baseline cohort assessment in approximately 4000 adults age 25-64 years, utilizing mobile health technologies to
- measure sleep apnea over seven consecutive nights;
- measure sleep duration, timing, regularity and fragmentation over multiple weeks; and
- administer standardized questionnaires to assess insomnia, chronotype, sleep quality, sleep-related impairment, and fatigue.
These data will allow us to leverage the planned extensive assessments of cardiometabolic risk factors, subclinical disease, and psychosocial and environmental stressors (and resilience factors) to address the following specific aims:
Aim 1a. Quantify population distributions of sleep health measures in a rural cohort along dimensions of sleep apnea, insomnia, chronotype, and sleep duration, efficiency, timing, and regularity.
Aim 1b. Identify psychosocial, behavioral, and environmental correlates of sleep health in rural communities.
Aim 2. Assess the association of sleep health with cardiometabolic risk factors and subclinical cardiovascular disease independent of other established cardiovascular and metabolic risk factors.
The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will consist of a general population sample of adults age 25-64 years residing in 10 counties in the rural Appalachia and Mississippi Delta regions (AMD): Alabama, Mississippi, Louisiana, and Kentucky, with counties sampled proportional to their populations. The projected RURAL Study sample size is 4600 individuals, with approximately equal numbers in each of the four age deciles. The sample is anticipated to include 51.7% women and 48.3% men. The projected racial/ethnic make-up of the sample is 63.8% non-Hispanic white, 32.7% non-Hispanic black, 1.7% Hispanic and 1.8% other.
Key inclusion criteria (1 listed)
- All participants in the Risk Underlying Rural Areas Longitudinal (RURAL) Study will be eligible for enrollment in this ancillary study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygen desaturation index
Time frame: 7 nights
Frequency of 4% drops in nocturnal blood oxygen saturation
Insomnia Severity Index
Time frame: Single measurement at baseline
min: 0, max: 28, higher score indicates more insomnia symptoms
Sleep Duration
Time frame: 3-6 months
Mean total sleep time from accelerometry
Sleep Duration Regularity
Time frame: 3-6 months
Variability in total sleep time from accelerometry
Sleep Timing
Time frame: 3-6 months
Sleep midpoint from accelerometry
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a
Time frame: Single measurement at baseline
raw score min: 8, max: 40; higher score indicates greater impairment
5 secondary outcomes
Restless Legs Syndrome (RLS)
Time frame: Single measurement at baseline
Chronotype
Time frame: Single measurement at baseline
Sleep Timing Regularity
Time frame: 7 days
Global Sleep Quality
Time frame: Single measurement at baseline
Oxygen desaturation index, 3%
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: Yes. De-identified oximetry data and the results of sleep questionnaires will be shared via the National Sleep Research Resource (NSRR) (sleepdata.org). The RURAL sleep data will be available for any researcher who provides an acceptable Data Access and Use Agreement and has appropriate regulatory approvals. The NSRR has procedures to streamline Institutional Review Board (IRB) approval (via an in house IRB process). The NSRR is in the process of migrating to Bio Data Catalyst, enabling easy linkage and interoperability with other Bio Data Catalyst data (from RURAL) and other cohorts to individuals with approved Database of Genotypes and Phenotypes (dbGaP) authorization. Other RURAL Study data that are integral to this project but were collected separately by the parent RURAL Study (e.g., non-sleep cardiovascular risk and outcomes data) will be distributed via RURAL Study data sharing mechanisms, including via Bio Data Catalyst and dbGaP.
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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.
Daniel J Gottlieb, MD, MPH principal investigator
Brigham and Women's Hospital
Tené Lewis, PhD principal investigator
Emory University
Tianyi Huang, PhD principal investigator
Harvard Chan School of Public Health
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 Apnea and Insomnia, run by Brigham and Women's Hospital 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 27 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Oxygen desaturation index (time frame: 7 nights). The study lists 6 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 27 Oct 2025.