Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Insomnia; Sleep Apnea; Sleep Deprivation; Sleep Disorders, Circadian Rhythm; Sleepiness, Excessive Daytime

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.

• Study Type: Observational
• Enrollment (Estimated): 3680

Contacts and Locations

• Study Contact: Name: Emi Martini; Phone Number: 774-420-9422; Email: emartini@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen desaturation index	Frequency of 4% drops in nocturnal blood oxygen saturation	7 nights
Sleep Duration	Mean total sleep time from accelerometry	3-6 months
Sleep Duration Regularity	Variability in total sleep time from accelerometry	3-6 months
Sleep Timing	Sleep midpoint from accelerometry	3-6 months
Insomnia Severity Index	min: 0, max: 28, higher score indicates more insomnia symptoms	Single measurement at baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a	raw score min: 8, max: 40; higher score indicates greater impairment	Single measurement at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronotype	Body's natural tendency to go to sleep and wake up at certain times	Single measurement at baseline
Sleep Timing Regularity	Variability in sleep midpoint from accelerometry	7 days
Oxygen desaturation index, 3%	Frequency of 3% drops in nocturnal blood oxygen saturation	7 days
Restless Legs Syndrome (RLS)	Restless Legs Syndrome, yes/no	Single measurement at baseline
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	Single measurement at baseline

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: University of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); Beth Israel Deaconess Medical Center; University of Alabama at Birmingham; Emory University; The University of Texas Health Science Center at San Antonio; University of Massachusetts, Worcester
• Investigators: Principal Investigator: Daniel J Gottlieb, MD, MPH, Brigham and Women's Hospital; Principal Investigator: Tené Lewis, PhD, Emory University; Principal Investigator: Tianyi Huang, PhD, Harvard Chan School of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Deprivation; Disorders of Excessive Somnolence; Sleepiness; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 2023P001895; R01HL164462 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Within one year of publication of primary study results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No