Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
1 other identifier
interventional
452
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedSeptember 21, 2023
November 1, 2022
2.2 years
October 12, 2017
December 15, 2021
November 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep Per 24 Hours
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
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 (11)
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.
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.
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).
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).
- +6 more secondary outcomes
Study Arms (6)
Control
NO INTERVENTIONNo changes to normal sleep habits.
Naps only
EXPERIMENTALAfter a baseline period, participants in this condition will be provided with the opportunity to nap in a quiet comfortable "nap cabin" in the study office for 30 minutes each afternoon on all work days.
Home sleep aids only
EXPERIMENTALAfter a baseline period, participants in this condition will be provided with a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful.
Home sleep aids + Sleep incentives
EXPERIMENTALAfter a baseline period, participants in this condition will be provided with a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful. In addition, they will be given a small payment for each additional minute of sleep over their mean nighttime sleep in the baseline period.
Naps + Home sleep aids
EXPERIMENTALAfter a baseline period, participants in this condition will be provided with: 1) the opportunity to nap in a quiet comfortable "nap cabin" in the study office for 30 minutes each afternoon on all work days, 2) a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful.
Naps + Home sleep aids + Sleep incentives
EXPERIMENTALAfter a baseline period, participants in this condition will be provided with: 1) the opportunity to nap in a quiet comfortable "nap cabin" in the study office for 30 minutes each afternoon on all work days, 2) a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish, and 3) a small payment for each additional minute of sleep over their mean nighttime sleep in the baseline period. The sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful.
Interventions
After a baseline period, participants in this condition will be provided with the opportunity to nap in a quiet comfortable "nap cabin" in the study office for 30 minutes each afternoon on all work days.
After a baseline period, participants in this condition will be provided with a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful.
After a baseline period, participants in this condition will be provided with a small payment for each additional minute of sleep over their mean nighttime sleep in the baseline period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Institute for Financial Management and Researchcollaborator
- Abdul Latif Jameel Poverty Action Labcollaborator
- Government of Tamil Nadu, Indiacollaborator
Study Sites (2)
Institute for Financial Management and Research
Chennai, Tamil Nadu, 600006, India
J-PAL South Asia
Chennai, Tamil Nadu, 600006, India
Related Publications (1)
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.
PMID: 34220361RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Heather Schofield
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Gautam Rao, PhD
Harvard University
- PRINCIPAL INVESTIGATOR
Frank Schilbach, PhD
Massachusetts Institute of Technology
- PRINCIPAL INVESTIGATOR
Margaret McConnell, PhD
Harvard School of Public Health (HSPH)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 26, 2017
Study Start
October 23, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
September 21, 2023
Results First Posted
September 21, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After publication.
We will make the de-identified data available upon request after publication.