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

NCT06336525 | Enrolling By Invitation

• 2 other identifiers: 2023P001895R01HL164462
• Study Type: observational
• Target: 3,680
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Insomnia; Sleep Deprivation; Sleep Disorders, Circadian Rhythm; Sleepiness, Excessive Daytime; Fatigue

Outcome Measures

Primary Outcomes (6)

• Oxygen desaturation index

  Frequency of 4% drops in nocturnal blood oxygen saturation

  7 nights

• Insomnia Severity Index

  min: 0, max: 28, higher score indicates more insomnia symptoms

  Single measurement at baseline

• 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

• 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 Outcomes (5)

• Restless Legs Syndrome (RLS)

  Single measurement at baseline

• Chronotype

  Single measurement at baseline

• Sleep Timing Regularity

  7 days

• Global Sleep Quality

  Single measurement at baseline

• Oxygen desaturation index, 3%

  7 days

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Alabama at Birmingham: collaborator
• Emory University: collaborator
• University of Pennsylvania: collaborator
• University of Massachusetts, Worcester: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Sleep Deprivation; Sleep Disorders, Circadian Rhythm; Disorders of Excessive Somnolence; Fatigue

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronobiology Disorders; Occupational Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within one year of publication of primary study results.

Locations

US (1)