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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03322358
Enrollment
452
Registered
2017-10-26
Start date
2017-10-23
Completion date
2019-12-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Depression

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.

Interventions

OTHERNaps

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.

DEVICEHome 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.

OTHERSleep 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep Per 24 HoursActigraphs 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.Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.

Secondary

MeasureTime frameDescription
DepressionDepression 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), 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 WeekIllness 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.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 ControlFrom 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). 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).
MemoryFrom 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).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).
AttentionFrom 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).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).
Blood PressureFrom 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. 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.
Physical FitnessPhysical 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 was set to the same level of resistance for all participants.
Activities of Daily LivingActivities 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 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-beingSubjective 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 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).
HappinessHappiness 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 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)
Self-reported PainPain 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. The outcome measure was the self-reported pain intensity captured at endline (day 28).

Countries

India

Participant flow

Participants by arm

ArmCount
Control
No changes to normal sleep habits.
77
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. 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.
75
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. 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.
75
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. 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. 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.
74
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. 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. 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.
75
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. 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. 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. 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.
76
Total452

Baseline characteristics

CharacteristicControlNaps OnlyHome Sleep Aids OnlyHome Sleep Aids + Sleep IncentivesNaps + Home Sleep AidsNaps + Home Sleep Aids + Sleep IncentivesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
77 Participants75 Participants75 Participants74 Participants75 Participants76 Participants452 Participants
Age, Continuous35.91 Years
STANDARD_DEVIATION 0.86
35.77 Years
STANDARD_DEVIATION 0.89
35.04 Years
STANDARD_DEVIATION 0.8
33.82 Years
STANDARD_DEVIATION 0.74
35.52 Years
STANDARD_DEVIATION 0.85
33.62 Years
STANDARD_DEVIATION 0.83
34.95 Years
STANDARD_DEVIATION 2.03
Hours of sleep/24 hours5.509 Hours of sleep/24 hours
STANDARD_DEVIATION 1.261
5.584 Hours of sleep/24 hours
STANDARD_DEVIATION 1.204
5.588 Hours of sleep/24 hours
STANDARD_DEVIATION 1.186
5.640 Hours of sleep/24 hours
STANDARD_DEVIATION 1.118
5.542 Hours of sleep/24 hours
STANDARD_DEVIATION 1.291
5.567 Hours of sleep/24 hours
STANDARD_DEVIATION 1.144
5.581 Hours of sleep/24 hours
STANDARD_DEVIATION 1.197
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
77 Participants75 Participants75 Participants74 Participants75 Participants76 Participants452 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
India
77 participants75 participants75 participants74 participants75 participants76 participants452 participants
Sex: Female, Male
Female
52 Participants48 Participants48 Participants47 Participants48 Participants56 Participants299 Participants
Sex: Female, Male
Male
25 Participants27 Participants27 Participants27 Participants27 Participants20 Participants153 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 770 / 750 / 750 / 740 / 750 / 76
other
Total, other adverse events
0 / 770 / 750 / 750 / 740 / 750 / 76
serious
Total, serious adverse events
0 / 770 / 750 / 750 / 740 / 750 / 76

Outcome results

Primary

Sleep Per 24 Hours

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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Per 24 Hours5.61 Hours of sleep/24 hoursStandard Deviation 1.2
Naps OnlySleep Per 24 Hours5.81 Hours of sleep/24 hoursStandard Deviation 1.259
Home Sleep Aids OnlySleep Per 24 Hours5.99 Hours of sleep/24 hoursStandard Deviation 1.239
Home Sleep Aids + Sleep IncentivesSleep Per 24 Hours6.23 Hours of sleep/24 hoursStandard Deviation 1.312
Naps + Home Sleep AidsSleep Per 24 Hours6.08 Hours of sleep/24 hoursStandard Deviation 1.305
Naps + Home Sleep Aids + Sleep IncentivesSleep Per 24 Hours6.35 Hours of sleep/24 hoursStandard Deviation 1.208
Secondary

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).

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.

ArmMeasureValue (MEAN)Dispersion
ControlActivities of Daily Living8.961 Score on a scaleStandard Deviation 7.378
Naps OnlyActivities of Daily Living7.52 Score on a scaleStandard Deviation 6.795
Home Sleep Aids OnlyActivities of Daily Living7.8 Score on a scaleStandard Deviation 7.674
Home Sleep Aids + Sleep IncentivesActivities of Daily Living7.486 Score on a scaleStandard Deviation 7.323
Naps + Home Sleep AidsActivities of Daily Living7.36 Score on a scaleStandard Deviation 6.06
Naps + Home Sleep Aids + Sleep IncentivesActivities of Daily Living7.553 Score on a scaleStandard Deviation 7.43
Secondary

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).

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).

ArmMeasureValue (MEAN)Dispersion
ControlAttention13.001 Indian RupeesStandard Deviation 1.568
Naps OnlyAttention13.338 Indian RupeesStandard Deviation 1.418
Home Sleep Aids OnlyAttention13.024 Indian RupeesStandard Deviation 1.569
Home Sleep Aids + Sleep IncentivesAttention13.005 Indian RupeesStandard Deviation 1.518
Naps + Home Sleep AidsAttention13.174 Indian RupeesStandard Deviation 1.589
Naps + Home Sleep Aids + Sleep IncentivesAttention13.150 Indian RupeesStandard Deviation 1.495
Secondary

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.

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.

ArmMeasureValue (MEAN)Dispersion
ControlBlood Pressure0.000 Blood pressure indexStandard Deviation 1
Naps OnlyBlood Pressure0.135 Blood pressure indexStandard Deviation 0.891
Home Sleep Aids OnlyBlood Pressure0.110 Blood pressure indexStandard Deviation 0.981
Home Sleep Aids + Sleep IncentivesBlood Pressure0.071 Blood pressure indexStandard Deviation 0.95
Naps + Home Sleep AidsBlood Pressure0.027 Blood pressure indexStandard Deviation 1.025
Naps + Home Sleep Aids + Sleep IncentivesBlood Pressure0.178 Blood pressure indexStandard Deviation 0.902
Secondary

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.

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.

ArmMeasureValue (MEAN)Dispersion
ControlDepression5.208 Score on 0-27 scaleStandard Deviation 5.131
Naps OnlyDepression4.676 Score on 0-27 scaleStandard Deviation 4.726
Home Sleep Aids OnlyDepression5.851 Score on 0-27 scaleStandard Deviation 5.529
Home Sleep Aids + Sleep IncentivesDepression5.095 Score on 0-27 scaleStandard Deviation 5.113
Naps + Home Sleep AidsDepression5.608 Score on 0-27 scaleStandard Deviation 5.226
Naps + Home Sleep Aids + Sleep IncentivesDepression5.147 Score on 0-27 scaleStandard Deviation 5.339
Secondary

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)

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.

ArmMeasureValue (MEAN)Dispersion
ControlHappiness2.455 Score on a scaleStandard Deviation 0.758
Naps OnlyHappiness2.517 Score on a scaleStandard Deviation 0.768
Home Sleep Aids OnlyHappiness2.421 Score on a scaleStandard Deviation 0.754
Home Sleep Aids + Sleep IncentivesHappiness2.440 Score on a scaleStandard Deviation 0.725
Naps + Home Sleep AidsHappiness2.580 Score on a scaleStandard Deviation 0.676
Naps + Home Sleep Aids + Sleep IncentivesHappiness2.502 Score on a scaleStandard Deviation 0.783
Secondary

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).

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).

ArmMeasureValue (MEAN)Dispersion
ControlInhibitory Control14.982 Indian RupeesStandard Deviation 1.371
Naps OnlyInhibitory Control14.957 Indian RupeesStandard Deviation 1.328
Home Sleep Aids OnlyInhibitory Control15.078 Indian RupeesStandard Deviation 1.213
Home Sleep Aids + Sleep IncentivesInhibitory Control14.982 Indian RupeesStandard Deviation 1.086
Naps + Home Sleep AidsInhibitory Control15.039 Indian RupeesStandard Deviation 1.338
Naps + Home Sleep Aids + Sleep IncentivesInhibitory Control15.103 Indian RupeesStandard Deviation 1.301
Secondary

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).

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).

ArmMeasureValue (MEAN)Dispersion
ControlMemory14.643 Indian RupeesStandard Deviation 2.675
Naps OnlyMemory14.834 Indian RupeesStandard Deviation 2.519
Home Sleep Aids OnlyMemory14.931 Indian RupeesStandard Deviation 2.499
Home Sleep Aids + Sleep IncentivesMemory14.483 Indian RupeesStandard Deviation 2.384
Naps + Home Sleep AidsMemory14.609 Indian RupeesStandard Deviation 2.796
Naps + Home Sleep Aids + Sleep IncentivesMemory14.645 Indian RupeesStandard Deviation 2.608
Secondary

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).

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.

ArmMeasureValue (MEAN)Dispersion
ControlNumber of Days of Illness in Past Week2.08 Days of illness in the past weekStandard Deviation 2.448
Naps OnlyNumber of Days of Illness in Past Week1.732 Days of illness in the past weekStandard Deviation 1.836
Home Sleep Aids OnlyNumber of Days of Illness in Past Week1.973 Days of illness in the past weekStandard Deviation 2.56
Home Sleep Aids + Sleep IncentivesNumber of Days of Illness in Past Week2.041 Days of illness in the past weekStandard Deviation 2.556
Naps + Home Sleep AidsNumber of Days of Illness in Past Week2.351 Days of illness in the past weekStandard Deviation 2.55
Naps + Home Sleep Aids + Sleep IncentivesNumber of Days of Illness in Past Week1.853 Days of illness in the past weekStandard Deviation 2.228
Secondary

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.

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.

ArmMeasureValue (MEAN)Dispersion
ControlPhysical Fitness3.717 kmStandard Deviation 1.626
Naps OnlyPhysical Fitness3.857 kmStandard Deviation 1.357
Home Sleep Aids OnlyPhysical Fitness3.941 kmStandard Deviation 1.924
Home Sleep Aids + Sleep IncentivesPhysical Fitness3.934 kmStandard Deviation 2.157
Naps + Home Sleep AidsPhysical Fitness3.697 kmStandard Deviation 1.446
Naps + Home Sleep Aids + Sleep IncentivesPhysical Fitness3.571 kmStandard Deviation 1.384
Secondary

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).

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.

ArmMeasureValue (MEAN)Dispersion
ControlSelf-reported Pain2.740 Score on a scaleStandard Deviation 2.721
Naps OnlySelf-reported Pain3.070 Score on a scaleStandard Deviation 2.276
Home Sleep Aids OnlySelf-reported Pain2.095 Score on a scaleStandard Deviation 2.517
Home Sleep Aids + Sleep IncentivesSelf-reported Pain2.838 Score on a scaleStandard Deviation 2.477
Naps + Home Sleep AidsSelf-reported Pain2.608 Score on a scaleStandard Deviation 2.52
Naps + Home Sleep Aids + Sleep IncentivesSelf-reported Pain2.800 Score on a scaleStandard Deviation 2.568
Secondary

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).

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.

ArmMeasureValue (MEAN)Dispersion
ControlSubjective Well-being11.554 Score on a scaleStandard Deviation 4.78
Naps OnlySubjective Well-being12.521 Score on a scaleStandard Deviation 4.004
Home Sleep Aids OnlySubjective Well-being11.906 Score on a scaleStandard Deviation 4.588
Home Sleep Aids + Sleep IncentivesSubjective Well-being11.919 Score on a scaleStandard Deviation 4.336
Naps + Home Sleep AidsSubjective Well-being12.757 Score on a scaleStandard Deviation 4.132
Naps + Home Sleep Aids + Sleep IncentivesSubjective Well-being12.199 Score on a scaleStandard Deviation 4.489

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026