Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 4
- 主要终点
- Sleep Per 24 Hours
研究概览
简要总结
A large body of medical research has shown that sleep deprivation adversely affects outcomes ranging from cognitive function to pain sensitivity and cardiovascular function. Much of this evidence comes from sleep labs in the developed world, where sleep can be carefully manipulated, and short-run physiological and cognitive outcomes precisely measured. In contrast, there is much less knowledge about how sleep deprivation affects the health of individuals in the developing world, coming from a lack of studies outside the lab and over longer periods. This project aims to fill this gap. The investigators will implement a randomized controlled trial (RCT) with 450 low-income adults in Chennai, India, providing the first objective measurement of sleep in a developing country. The investigators will also evaluate scalable interventions to improve the sleep of poor adults, such as providing home sleep-aid devices and a comfortable space for a 30-minute afternoon nap at the participants' work site. Finally, the study aims to assess the impact of improved sleep on health, with a primary focus on cardiovascular health and cognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unemployed and underemployed adult men and women of working age (see previous age limit) who have worked less than 5 days per week over the last month and earned less than Rs. 700 per day over that same period.
- •Participants must live in Government board house or in a house with some kind of roof that protect the sleep aids from rain, such as a concrete or a metal or a Tarpaulin, ... roof.
- •Have limited experience with typing, and limited knowledge of English.
- •Participants need to speak Tamil, the local language, to be able to write numbers and to be able to commit easily to the office.
排除标准
- •Participants who cannot commit to come to the office for the duration of the whole study.
- •Participants who own more than three of the sleep aids that we provide in our sleep kit.
- •Participants who have previously participated in the sleep study.
- •Participants who have children younger than three years old.
结局指标
主要结局
Sleep Per 24 Hours
时间窗: Actigraphs are worn consistently throughout the study. The sleep per 24 hour period outcome is then measured every day through study completion, which is 28 business days (as well as intervening holidays and Sundays) for each participant.
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
次要结局
- Blood Pressure(From date of entering the study through completion of the study after 28 business days, blood pressure is measured once every block of three business days. The date of measurement is randomized within each block between the first, second, and third day.)
- Activities of Daily Living(Activities of daily living are measured once in the baseline on the first day of the study and a second time in the endline, which takes place on the last day of the study, 28 business days after the first day in the study for the participant.)
- Inhibitory Control(From date of entering the study through completion of the study after 28 business days, the inhibitory control is measured once every two business days (which of the two is randomly assigned).)
- Happiness(Happiness is measured in the baseline on the first day of the study, randomly once every block of three business days during the study, and a last time in the endline, on the last day of the study, 28 business days after the participant's first day.)
- Depression(Depression is measured once in the baseline on the first day of the study and a second time in the endline, which takes place on the last day of the study, 28 business days after the first day in the study for the participant.)
- Number of Days of Illness in Past Week(Illness is measured once in the baseline on the first day of the study and a second time in the endline, which takes place on the last day of the study, 28 business days after the first day in the study for the participant.)
- Attention(From date of entering the study through completion of the study after 28 business days, attention is measured once every two business days (which of the two is randomly assigned).)
- Memory(From date of entering the study through completion of the study after 28 business days, memory is measured once every two business days (which of the two is randomly assigned).)
- Self-reported Pain(Pain is measured once in the baseline on the first day of the study and a second time in the endline, which takes place on the last day of the study, 28 days after the first day in the study for the participant.)
- Physical Fitness(Physical fitness is measured only once in the endline, which takes place on the last day of the study, 28 business days after the first day in the study for the participant.)
- Subjective Well-being(Subjective well-being is measured once in the baseline on the first day of the study and a second time in the endline, which takes place on the last day of the study, 28 business days after the first day in the study for the participant.)
研究者
Heather Schofield
Assistant Professor
University of Pennsylvania