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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06336525
• Other study ID #: 2023P001895
• Secondary ID: R01HL164462
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Emi Martini
• Phone: 774-420-9422
• Email: emartini[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3680
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Fatigue
• Insomnia
• Sleep Apnea
• Sleep Deprivation
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders
• Sleepiness

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen desaturation index	Frequency of 4% drops in nocturnal blood oxygen saturation	7 nights
Primary	Insomnia Severity Index	min: 0, max: 28, higher score indicates more insomnia symptoms	Single measurement at baseline
Primary	Sleep Duration	Mean total sleep time from accelerometry	3-6 months
Primary	Sleep Duration Regularity	Variability in total sleep time from accelerometry	3-6 months
Primary	Sleep Timing	Sleep midpoint from accelerometry	3-6 months
Primary	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	Restless Legs Syndrome (RLS)	Restless Legs Syndrome, yes/no	Single measurement at baseline
Secondary	Chronotype	Body's natural tendency to go to sleep and wake up at certain times	Single measurement at baseline
Secondary	Sleep Timing Regularity	Variability in sleep midpoint from accelerometry	7 days
Secondary	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
Secondary	Oxygen desaturation index, 3%	Frequency of 3% drops in nocturnal blood oxygen saturation	7 days