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

University of Pennsylvania

Status: Completed

Conditions: Depression; Blood Pressure

Treatments: Device: Home sleep aids; Other: Sleep incentives; Other: Naps

Study type: Interventional

Funder types: Other

Identifiers

NCT03322358

14-2294

Details and patient eligibility

About

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.

Enrollment: 452 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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452 participants in 6 patient groups

Control

No Intervention group

Description:

No changes to normal sleep habits.

Naps only

Experimental group

Description:

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.

Treatment:

Other: Naps

Home sleep aids only

Experimental group

Description:

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.

Treatment:

Device: Home sleep aids

Home sleep aids + Sleep incentives

Experimental group

Description:

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.

Treatment:

Device: Home sleep aids

Other: Sleep incentives

Naps + Home sleep aids

Experimental group

Description:

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.

Treatment:

Device: Home sleep aids

Other: Naps

Naps + Home sleep aids + Sleep incentives

Experimental group

Description:

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.

Treatment:

Device: Home sleep aids

Other: Naps

Other: Sleep incentives