跳至主要内容
临床试验/NCT06336525
NCT06336525Enrolling By Invitation不适用

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

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 3,680 人开始时间: 2024年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
3,680
试验地点
1
主要终点
Oxygen desaturation index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Oxygen desaturation index

时间窗: 7 nights

Frequency of 4% drops in nocturnal blood oxygen saturation

Sleep Duration

时间窗: 3-6 months

Mean total sleep time from accelerometry

Sleep Duration Regularity

时间窗: 3-6 months

Variability in total sleep time from accelerometry

Sleep Timing

时间窗: 3-6 months

Sleep midpoint from accelerometry

Insomnia Severity Index

时间窗: 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

时间窗: Single measurement at baseline

raw score min: 8, max: 40; higher score indicates greater impairment

次要结局

  • Global Sleep Quality(Single measurement at baseline)
  • Chronotype(Single measurement at baseline)
  • Sleep Timing Regularity(7 days)
  • Oxygen desaturation index, 3%(7 days)
  • Restless Legs Syndrome (RLS)(Single measurement at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel J.Gottlieb, M.D.,M.P.H.

Medical Doctor

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验

Adult Sleep Health in the Rural Appalachia and... | 临床试验