Sleep Health in the Rural South and Its Relationships With Cardiometabolic Health Disparities
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
- 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.
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
- 否
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
Daniel J.Gottlieb, M.D.,M.P.H.
Medical Doctor
Brigham and Women's Hospital
