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NCT Number: NCT06336525

Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Oxygen desaturation index

    Time frame: 7 nights

    Frequency of 4% drops in nocturnal blood oxygen saturation

  2. Insomnia Severity Index

    Time frame: Single measurement at baseline

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

  3. Sleep Duration

    Time frame: 3-6 months

    Mean total sleep time from accelerometry

  4. Sleep Duration Regularity

    Time frame: 3-6 months

    Variability in total sleep time from accelerometry

  5. Sleep Timing

    Time frame: 3-6 months

    Sleep midpoint from accelerometry

  6. 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

Secondary outcomes

  1. Restless Legs Syndrome (RLS)

    Time frame: Single measurement at baseline

    Restless Legs Syndrome, yes/no

  2. Chronotype

    Time frame: Single measurement at baseline

    Body's natural tendency to go to sleep and wake up at certain times

  3. Sleep Timing Regularity

    Time frame: 7 days

    Variability in sleep midpoint from accelerometry

  4. Global Sleep Quality

    Time frame: Single measurement at baseline

    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

  5. Oxygen desaturation index, 3%

    Time frame: 7 days

    Frequency of 3% drops in nocturnal blood oxygen saturation

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Emory University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • The University of Texas Health Science Center at San Antonio
  • University of Alabama at Birmingham
  • University of Massachusetts, Worcester
  • University of Pennsylvania

Registry information

Official study title

Sleep Health in the Rural South and Its Relationships With Cardiometabolic Health Disparities

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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