Clinical trial NCT06336525: Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.
Official title: Sleep Health in the Rural South and Its Relationships With Cardiometabolic Health Disparities
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Apnea
Insomnia
Sleep Deprivation
Sleep Disorders, Circadian Rhythm
Sleepiness, Excessive Daytime
Fatigue
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Emory University
name: University of Pennsylvania
name: University of Massachusetts, Worcester
name: The University of Texas Health Science Center at San Antonio
name: Beth Israel Deaconess Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-03-28
Enrollment: 3680
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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

1. measure sleep apnea over seven consecutive nights;
2. measure sleep duration, timing, regularity and fragmentation over multiple weeks; and
3. 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.

Eligibility criteria: Inclusion Criteria:

* All participants in the Risk Underlying Rural Areas Longitudinal (RURAL) Study will be eligible for enrollment in this ancillary study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Oxygen desaturation index
timeFrame: 7 nights
measure: Insomnia Severity Index
timeFrame: Single measurement at baseline
measure: Sleep Duration
timeFrame: 3-6 months
measure: Sleep Duration Regularity
timeFrame: 3-6 months
measure: Sleep Timing
timeFrame: 3-6 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a
timeFrame: Single measurement at baseline
Secondary outcomes:
measure: Restless Legs Syndrome (RLS)
timeFrame: Single measurement at baseline
measure: Chronotype
timeFrame: Single measurement at baseline
measure: Sleep Timing Regularity
timeFrame: 7 days
measure: Global Sleep Quality
timeFrame: Single measurement at baseline
measure: Oxygen desaturation index, 3%
timeFrame: 7 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Daniel J Gottlieb, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Tené Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Chan School of Public Health
name: Tianyi Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: