Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach

NCT ID: NCT03322358

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2019-12-31

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.

Conditions

Blood Pressure; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

No changes to normal sleep habits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Naps only

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.

Group Type: EXPERIMENTAL

Naps

Intervention Type: OTHER

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.

Home sleep aids only

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.

Group Type: EXPERIMENTAL

Home sleep aids

Intervention Type: DEVICE

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.

Home sleep aids + Sleep incentives

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. In addition, they will be given a small payment for each additional minute of sleep over their mean nighttime sleep in the baseline period.

Group Type: EXPERIMENTAL

Home sleep aids

Intervention Type: DEVICE

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.

Sleep incentives

Intervention Type: OTHER

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.

Naps + Home sleep aids

After 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.

Group Type: EXPERIMENTAL

Naps

Intervention Type: OTHER

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.

Home sleep aids

Intervention Type: DEVICE

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.

Naps + Home sleep aids + Sleep incentives

After 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.

Group Type: EXPERIMENTAL

Naps

Intervention Type: OTHER

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.

Home sleep aids

Intervention Type: DEVICE

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.

Sleep incentives

Intervention Type: OTHER

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.

Interventions

Naps

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.

Intervention Type: OTHER

Home sleep aids

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.

Intervention Type: DEVICE

Sleep incentives

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Financial Management and Research

OTHER

Sponsor Role: collaborator

Abdul Latif Jameel Poverty Action Lab

OTHER

Sponsor Role: collaborator

Government of Tamil Nadu, India

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Heather Schofield

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gautam Rao, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Frank Schilbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Margaret McConnell, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Institute for Financial Management and Research

Chennai, Tamil Nadu, India

J-PAL South Asia

Chennai, Tamil Nadu, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 34220361 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

14-2294

Identifier Type: -

Identifier Source: org_study_id