Back to resultsChronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Primary Purpose
Blood Pressure, Depression
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Naps
Home sleep aids
Sleep incentives
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure
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.
Sites / Locations
- Institute for Financial Management and Research
- J-PAL South Asia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Control
Naps only
Home sleep aids only
Home sleep aids + Sleep incentives
Naps + Home sleep aids
Naps + Home sleep aids + Sleep incentives
Arm Description
No changes to normal sleep habits.
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 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.
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.
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.
Outcomes
Primary Outcome Measures
Sleep Per 24 Hours
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
Secondary Outcome Measures
Blood Pressure
Systolic, Diastolic. The outcome measurements reported here are those captured after the baseline period (starting on day 9). Each measure is first winsorized at the 5% level and standardized using control group data, to mean 0 and standard deviation 1. The measure is then multiplied by -1 such that higher values represent improvements in health. In order to analyze these outcomes jointly, this measure is next averaged to obtain an overall measure and standardized again. The mean is taken across all participant observations within a group regardless of the time after the baseline period. There are no clinically relevant values and the measure has no max and min.
Depression
The investigators measure depression using a scale defined by the Patient Health Questionnaire (PHQ), which is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. Each criteria is scored from "0" (not at all, a better outcome) to "3" (nearly every day, a worse outcome). Scores on each question are summed, defining depression severity. The outcome measure was the total summed score captured at endline (day 28). The outcome is thus measured on a scale from 0 to 27, where 0 represents the best outcome and 27 represents the worst outcome.
Number of Days of Illness in Past Week
Illness is measured as the number of days of illness (e.g. cough, fever) in the past week. The outcome measure is the number of days of illness in the past week self-reported at endline (day 28).
Inhibitory Control
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). Specifically, the payment for this task is determined by the formula: 1.5 * ((percent correct - 0.84) / 0.2 - (reaction time - 526.5) / 95.2) + 15. The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9).
Memory
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). The outcome reported for this task is the participant's payment from the task, which is computed based on their longest span as well as baseline data: 2.29*(maximum span - 5.3) / 1.17 + 13. The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9).
Attention
Psychomotor Vigilance Task (PVT) - The outcome is payment for the task which was a predetermined 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). Specifically, the payment was determined by the formula: (inverse reaction time - 3.5)/0.42 - (0.5*(number of false positives-4.7)/6.14) - (0.5*(number of lapses-1.3)/2.58) + 15. Higher payments indicate better performance. Although the theoretical minimum possible score is negative infinity, in practice, the minimum possible payment was censored at zero. The maximum theoretical payment is undefined. The payment reflects overall performance. The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9).
Self-reported Pain
The investigators use a simple scale of 0 (no pain) to 10 (the worst pain imaginable) for the participant to rate their pain intensity. The outcome measure was the self-reported pain intensity captured at endline (day 28).
Physical Fitness
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 was set to the same level of resistance for all participants.
Activities of Daily Living
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 worst 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. The outcome measure is the 0-36 scale captured at endline (day 28).
Subjective Well-being
The measure of the outcome is based on two survey questions taken from Gallup Survey. In the first question, participants are asked to state a number from 0 to 10, 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. In the second question, participants are asked to state a number from 0 to 10, with 0 being a feeling that the participant is dissatisfied with life as a whole and 10 being a feeling that the participant is satisfied with life as a whole. The final scale, generated by summing the individual items, is then from 0 for highly dissatisfied people to 20 for highly satisfied people. The outcome measure is the 0-20 scale captured at endline (day 28).
Happiness
The investigators use a question adapted from a Gallup poll and from the SF-36 survey by RAND that ask participants to rate their happiness on the present day from "Not at all happy" (0, the worst outcome) to "very happy" (4, the best outcome). The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9)
Full Information
NCT ID
NCT03322358
First Posted
October 12, 2017
Last Updated
November 11, 2022
Sponsor
University of Pennsylvania
Collaborators
Institute for Financial Management and Research, Abdul Latif Jameel Poverty Action Lab, Government of Tamil Nadu, India
1. Study Identification
Unique Protocol Identification Number
NCT03322358
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Institute for Financial Management and Research, Abdul Latif Jameel Poverty Action Lab, Government of Tamil Nadu, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No changes to normal sleep habits.
Arm Title
Naps only
Arm Type
Experimental
Arm 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.
Arm Title
Home sleep aids only
Arm Type
Experimental
Arm 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.
Arm Title
Home sleep aids + Sleep incentives
Arm Type
Experimental
Arm 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.
Arm Title
Naps + Home sleep aids
Arm Type
Experimental
Arm 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.
Arm Title
Naps + Home sleep aids + Sleep incentives
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Naps
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Home sleep aids
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Sleep incentives
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Per 24 Hours
Description
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
Time Frame
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 Outcome Measure Information:
Title
Blood Pressure
Description
Systolic, Diastolic. The outcome measurements reported here are those captured after the baseline period (starting on day 9). Each measure is first winsorized at the 5% level and standardized using control group data, to mean 0 and standard deviation 1. The measure is then multiplied by -1 such that higher values represent improvements in health. In order to analyze these outcomes jointly, this measure is next averaged to obtain an overall measure and standardized again. The mean is taken across all participant observations within a group regardless of the time after the baseline period. There are no clinically relevant values and the measure has no max and min.
Time Frame
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.
Title
Depression
Description
The investigators measure depression using a scale defined by the Patient Health Questionnaire (PHQ), which is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. Each criteria is scored from "0" (not at all, a better outcome) to "3" (nearly every day, a worse outcome). Scores on each question are summed, defining depression severity. The outcome measure was the total summed score captured at endline (day 28). The outcome is thus measured on a scale from 0 to 27, where 0 represents the best outcome and 27 represents the worst outcome.
Time Frame
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.
Title
Number of Days of Illness in Past Week
Description
Illness is measured as the number of days of illness (e.g. cough, fever) in the past week. The outcome measure is the number of days of illness in the past week self-reported at endline (day 28).
Time Frame
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.
Title
Inhibitory Control
Description
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). Specifically, the payment for this task is determined by the formula: 1.5 * ((percent correct - 0.84) / 0.2 - (reaction time - 526.5) / 95.2) + 15. The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9).
Time Frame
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).
Title
Memory
Description
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). The outcome reported for this task is the participant's payment from the task, which is computed based on their longest span as well as baseline data: 2.29*(maximum span - 5.3) / 1.17 + 13. The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9).
Time Frame
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).
Title
Attention
Description
Psychomotor Vigilance Task (PVT) - The outcome is payment for the task which was a predetermined 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). Specifically, the payment was determined by the formula: (inverse reaction time - 3.5)/0.42 - (0.5*(number of false positives-4.7)/6.14) - (0.5*(number of lapses-1.3)/2.58) + 15. Higher payments indicate better performance. Although the theoretical minimum possible score is negative infinity, in practice, the minimum possible payment was censored at zero. The maximum theoretical payment is undefined. The payment reflects overall performance. The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9).
Time Frame
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).
Title
Self-reported Pain
Description
The investigators use a simple scale of 0 (no pain) to 10 (the worst pain imaginable) for the participant to rate their pain intensity. The outcome measure was the self-reported pain intensity captured at endline (day 28).
Time Frame
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.
Title
Physical Fitness
Description
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 was set to the same level of resistance for all participants.
Time Frame
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.
Title
Activities of Daily Living
Description
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 worst 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. The outcome measure is the 0-36 scale captured at endline (day 28).
Time Frame
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.
Title
Subjective Well-being
Description
The measure of the outcome is based on two survey questions taken from Gallup Survey. In the first question, participants are asked to state a number from 0 to 10, 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. In the second question, participants are asked to state a number from 0 to 10, with 0 being a feeling that the participant is dissatisfied with life as a whole and 10 being a feeling that the participant is satisfied with life as a whole. The final scale, generated by summing the individual items, is then from 0 for highly dissatisfied people to 20 for highly satisfied people. The outcome measure is the 0-20 scale captured at endline (day 28).
Time Frame
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.
Title
Happiness
Description
The investigators use a question adapted from a Gallup poll and from the SF-36 survey by RAND that ask participants to rate their happiness on the present day from "Not at all happy" (0, the worst outcome) to "very happy" (4, the best outcome). The outcome measure is the average of the measures collected for each individual after the baseline period (starting on day 9)
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gautam Rao, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Schilbach, PhD
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret McConnell, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Financial Management and Research
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
J-PAL South Asia
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will make the de-identified data available upon request after publication.
IPD Sharing Time Frame
After publication.
Citations:
PubMed Identifier
34220361
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.sleepdata.org/datasets/urbanpoor
Learn more about this trial
Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
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