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

Not yet recruiting

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

• Registration Number: NCT06336525
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Study Start: 2024-05-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3680

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States