Trial Outcomes & Findings for Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach (NCT NCT03322358)
NCT ID: NCT03322358
Last Updated: 2023-09-21
Results Overview
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
452 participants
Primary outcome timeframe
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.
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Control
No changes to normal sleep habits.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
75
|
75
|
74
|
75
|
76
|
|
Overall Study
COMPLETED
|
77
|
75
|
75
|
74
|
75
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Baseline characteristics by cohort
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
74 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
76 Participants
n=10 Participants
|
452 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
35.91 Years
STANDARD_DEVIATION 0.86 • n=93 Participants
|
35.77 Years
STANDARD_DEVIATION 0.89 • n=4 Participants
|
35.04 Years
STANDARD_DEVIATION 0.80 • n=27 Participants
|
33.82 Years
STANDARD_DEVIATION 0.74 • n=483 Participants
|
35.52 Years
STANDARD_DEVIATION 0.85 • n=36 Participants
|
33.62 Years
STANDARD_DEVIATION 0.83 • n=10 Participants
|
34.95 Years
STANDARD_DEVIATION 2.03 • n=115 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
56 Participants
n=10 Participants
|
299 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
20 Participants
n=10 Participants
|
153 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
77 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
74 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
76 Participants
n=10 Participants
|
452 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
India
|
77 participants
n=93 Participants
|
75 participants
n=4 Participants
|
75 participants
n=27 Participants
|
74 participants
n=483 Participants
|
75 participants
n=36 Participants
|
76 participants
n=10 Participants
|
452 participants
n=115 Participants
|
|
Hours of sleep/24 hours
|
5.509 Hours of sleep/24 hours
STANDARD_DEVIATION 1.261 • n=93 Participants
|
5.584 Hours of sleep/24 hours
STANDARD_DEVIATION 1.204 • n=4 Participants
|
5.588 Hours of sleep/24 hours
STANDARD_DEVIATION 1.186 • n=27 Participants
|
5.640 Hours of sleep/24 hours
STANDARD_DEVIATION 1.118 • n=483 Participants
|
5.542 Hours of sleep/24 hours
STANDARD_DEVIATION 1.291 • n=36 Participants
|
5.567 Hours of sleep/24 hours
STANDARD_DEVIATION 1.144 • n=10 Participants
|
5.581 Hours of sleep/24 hours
STANDARD_DEVIATION 1.197 • n=115 Participants
|
PRIMARY outcome
Timeframe: 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.Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Sleep Per 24 Hours
|
5.61 Hours of sleep/24 hours
Standard Deviation 1.200
|
5.81 Hours of sleep/24 hours
Standard Deviation 1.259
|
5.99 Hours of sleep/24 hours
Standard Deviation 1.239
|
6.23 Hours of sleep/24 hours
Standard Deviation 1.312
|
6.08 Hours of sleep/24 hours
Standard Deviation 1.305
|
6.35 Hours of sleep/24 hours
Standard Deviation 1.208
|
SECONDARY outcome
Timeframe: 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. 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.
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Blood Pressure
|
0.000 Blood pressure index
Standard Deviation 1.000
|
0.135 Blood pressure index
Standard Deviation 0.891
|
0.110 Blood pressure index
Standard Deviation 0.981
|
0.071 Blood pressure index
Standard Deviation 0.950
|
0.027 Blood pressure index
Standard Deviation 1.025
|
0.178 Blood pressure index
Standard Deviation 0.902
|
SECONDARY outcome
Timeframe: 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), 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.
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Depression
|
5.208 Score on 0-27 scale
Standard Deviation 5.131
|
4.676 Score on 0-27 scale
Standard Deviation 4.726
|
5.851 Score on 0-27 scale
Standard Deviation 5.529
|
5.095 Score on 0-27 scale
Standard Deviation 5.113
|
5.608 Score on 0-27 scale
Standard Deviation 5.226
|
5.147 Score on 0-27 scale
Standard Deviation 5.339
|
SECONDARY outcome
Timeframe: 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.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).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Days of Illness in Past Week
|
2.08 Days of illness in the past week
Standard Deviation 2.448
|
1.732 Days of illness in the past week
Standard Deviation 1.836
|
1.973 Days of illness in the past week
Standard Deviation 2.560
|
2.041 Days of illness in the past week
Standard Deviation 2.556
|
2.351 Days of illness in the past week
Standard Deviation 2.550
|
1.853 Days of illness in the past week
Standard Deviation 2.228
|
SECONDARY outcome
Timeframe: 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). 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).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Inhibitory Control
|
14.982 Indian Rupees
Standard Deviation 1.371
|
14.957 Indian Rupees
Standard Deviation 1.328
|
15.078 Indian Rupees
Standard Deviation 1.213
|
14.982 Indian Rupees
Standard Deviation 1.086
|
15.039 Indian Rupees
Standard Deviation 1.338
|
15.103 Indian Rupees
Standard Deviation 1.301
|
SECONDARY outcome
Timeframe: 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).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).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Memory
|
14.643 Indian Rupees
Standard Deviation 2.675
|
14.834 Indian Rupees
Standard Deviation 2.519
|
14.931 Indian Rupees
Standard Deviation 2.499
|
14.483 Indian Rupees
Standard Deviation 2.384
|
14.609 Indian Rupees
Standard Deviation 2.796
|
14.645 Indian Rupees
Standard Deviation 2.608
|
SECONDARY outcome
Timeframe: 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).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).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Attention
|
13.001 Indian Rupees
Standard Deviation 1.568
|
13.338 Indian Rupees
Standard Deviation 1.418
|
13.024 Indian Rupees
Standard Deviation 1.569
|
13.005 Indian Rupees
Standard Deviation 1.518
|
13.174 Indian Rupees
Standard Deviation 1.589
|
13.150 Indian Rupees
Standard Deviation 1.495
|
SECONDARY outcome
Timeframe: 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. The outcome measure was the self-reported pain intensity captured at endline (day 28).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Self-reported Pain
|
2.740 Score on a scale
Standard Deviation 2.721
|
3.070 Score on a scale
Standard Deviation 2.276
|
2.095 Score on a scale
Standard Deviation 2.517
|
2.838 Score on a scale
Standard Deviation 2.477
|
2.608 Score on a scale
Standard Deviation 2.520
|
2.800 Score on a scale
Standard Deviation 2.568
|
SECONDARY outcome
Timeframe: 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 was set to the same level of resistance for all participants.
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Physical Fitness
|
3.717 km
Standard Deviation 1.626
|
3.857 km
Standard Deviation 1.357
|
3.941 km
Standard Deviation 1.924
|
3.934 km
Standard Deviation 2.157
|
3.697 km
Standard Deviation 1.446
|
3.571 km
Standard Deviation 1.384
|
SECONDARY outcome
Timeframe: 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 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).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Activities of Daily Living
|
8.961 Score on a scale
Standard Deviation 7.378
|
7.52 Score on a scale
Standard Deviation 6.795
|
7.8 Score on a scale
Standard Deviation 7.674
|
7.486 Score on a scale
Standard Deviation 7.323
|
7.36 Score on a scale
Standard Deviation 6.060
|
7.553 Score on a scale
Standard Deviation 7.430
|
SECONDARY outcome
Timeframe: 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 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).
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Subjective Well-being
|
11.554 Score on a scale
Standard Deviation 4.78
|
12.521 Score on a scale
Standard Deviation 4.004
|
11.906 Score on a scale
Standard Deviation 4.588
|
11.919 Score on a scale
Standard Deviation 4.336
|
12.757 Score on a scale
Standard Deviation 4.132
|
12.199 Score on a scale
Standard Deviation 4.489
|
SECONDARY outcome
Timeframe: 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 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)
Outcome measures
| Measure |
Control
n=77 Participants
No changes to normal sleep habits.
|
Naps Only
n=75 Participants
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.
|
Home Sleep Aids Only
n=75 Participants
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.
|
Home Sleep Aids + Sleep Incentives
n=74 Participants
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.
|
Naps + Home Sleep Aids
n=75 Participants
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.
|
Naps + Home Sleep Aids + Sleep Incentives
n=76 Participants
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.
|
|---|---|---|---|---|---|---|
|
Happiness
|
2.455 Score on a scale
Standard Deviation 0.758
|
2.517 Score on a scale
Standard Deviation 0.768
|
2.421 Score on a scale
Standard Deviation 0.754
|
2.440 Score on a scale
Standard Deviation 0.725
|
2.580 Score on a scale
Standard Deviation 0.676
|
2.502 Score on a scale
Standard Deviation 0.783
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naps Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Sleep Aids Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Sleep Aids + Sleep Incentives
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naps + Home Sleep Aids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naps + Home Sleep Aids + Sleep Incentives
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place