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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03322358
Collaborator
Institute for Financial Management and Research (Other), Abdul Latif Jameel Poverty Action Lab (Other), Government of Tamil Nadu, India (Other)
452
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226
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Naps
  • Device: Home sleep aids
  • Other: Sleep incentives
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
452 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Actual Study Start Date :
Oct 23, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

No changes to normal sleep habits.

Experimental: 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.

Other: 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.

Experimental: 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.

Device: 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.

Experimental: 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.

Device: 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.

Other: 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.

Experimental: 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.

Other: 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.

Device: 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.

Experimental: 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.

Other: 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.

Device: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Sleep per 24 hours [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.]

    Measured via actigraph

Secondary Outcome Measures

  1. 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.]

    Systolic, Diastolic, pre-hypertensive, and hypertensive

  2. 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.]

    The investigators measure depression using a scale defined by the Patient Health Questionnaire (PHQ-9), which is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. Participants answer 9 questions, checking criteria from "0" (not at all, a better outcome) to "3" (nearly every day, a worse outcome). They receive a total score out of 27 by adding up scores for each question, defining depression severity, with scores ranging from a minimum of 0-4 corresponding to "none" to a maximum of 20-27 corresponding to "severe". The outcome measure will be the total summed score.

  3. Illness [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.]

    Days of illness (e.g. cough, fever) in the past week

  4. 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).]

    Hearts and flowers test -- The outcome used is the payment for the task which is a linear combination of the participant's accuracy (percent correct) and reaction time (measured in milliseconds).

  5. Memory [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).]

    Corsi block span - The investigators' measure of memory is the longest correct sequence of blocks lighting in a random order that a participant can reproduce. The range is from a minimum of 0 (worst performance) to a maximum of 9 (best performance).

  6. Attention [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).]

    PVT - The primary outcome is payment for the task which is a linear combination of the inverse reaction time, the number of false positives (response when they participant should not have responded), and the number of lapses (reaction time >500ms).

  7. 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.]

    The investigators use a simple scale of 0 (no pain) to 10 (the worst pain imaginable) for the participant to rate their pain intensity. An additional survey question (multiple choice, selecting all that apply) are used to determine the location of the pain (e.g. back, shoulders, hands).

  8. 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.]

    The outcome measure is the number of kilometers participants can cover on a stationary exercise cycle over a period of 30 minutes, as reported on the display of the exercise cycle.The cycle will be set to the same level of resistance for all participants.

  9. 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.]

    The investigators use survey questions taken from the commonly used SF-36 Health survey asking participants how much their health has limited them in a certain number of activities. The possible answers range from "they did not limit you at all" (0, the best outcome) to "limited you a lot" (3, the worse outcome). The final scale, which is the sum of the answers, goes from 0 for people who are not limited at all in their daily life by their health to 36 for people who are substantially limited in their daily life by their health.

  10. 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.]

    The measure of the outcome is based on overall three survey questions taken from Gallup Survey. Participants are asked to state a number from 0 to 10 to respond to these questions, with 0 being a feeling that the participant has the worst possible life while 10 is a feeling that the participant has the best possible life. The final scale, generated by summing the individual items, is then from 0 for highly dissatisfied people to 30 for highly satisfied people.

  11. 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.]

    The investigators use two questions adapted from a Gallup poll and from the SF-36 survey by RAND that ask participants to rate their happiness on the present day and on a typical day from "Not at all happy" (0, the worst outcome) to "very happy" (4, the best outcome). These scales will be examined individually.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Financial Management and Research Chennai Tamil Nadu India 600006
2 J-PAL South Asia Chennai Tamil Nadu India 600006

Sponsors and Collaborators

  • University of Pennsylvania
  • Institute for Financial Management and Research
  • Abdul Latif Jameel Poverty Action Lab
  • Government of Tamil Nadu, India

Investigators

  • 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)

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Heather Schofield, Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03322358
Other Study ID Numbers:
  • 14-2294
First Posted:
Oct 26, 2017
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2020