Clinical trial NCT03322358: Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Official title: Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Institute for Financial Management and Research
name: Abdul Latif Jameel Poverty Action Lab
name: Government of Tamil Nadu, India
First posted: 2017-10-26
Enrollment: 452
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sleep Per 24 Hours
timeFrame: 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.
Secondary outcomes:
measure: Blood Pressure
timeFrame: 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.
measure: Depression
timeFrame: 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.
measure: Number of Days of Illness in Past Week
timeFrame: 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.
measure: Inhibitory Control
timeFrame: 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).
measure: Memory
timeFrame: 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).
measure: Attention
timeFrame: 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).
measure: Self-reported Pain
timeFrame: 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.
measure: Physical Fitness
timeFrame: 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.
measure: Activities of Daily Living
timeFrame: 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.
measure: Subjective Well-being
timeFrame: 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.
measure: Happiness
timeFrame: 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.
Other outcomes:
Locations:
city: Chennai
country: India
facility: Institute for Financial Management and Research
state: Tamil Nadu
city: Chennai
country: India
facility: J-PAL South Asia
state: Tamil Nadu
Study officials:
affiliation: Harvard University
name: Gautam Rao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts Institute of Technology
name: Frank Schilbach, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Margaret McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bessone P, Rao G, Schilbach F, Schofield H, Toma M. The Economic Consequences of Increasing Sleep Among the Urban Poor. Q J Econ. 2021 Apr 8;136(3):1887-1941. doi: 10.1093/qje/qjab013. eCollection 2021 Aug.