Blood PressureNCT03322358
Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
A study testing Naps, Home sleep aids and Sleep incentives in people with Blood Pressure and Depression, run by University of Pennsylvania at 2 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Depression
- What is being tested?
- Naps, Home sleep aids and Sleep incentives
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 2 sitesIndia
- Study dates
- 23 Oct 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Participants who cannot commit to come to the office for the duration of the whole study.
- Participants who own more than three of the sleep aids that we provide in our sleep kit.
- Participants who have previously participated in the sleep study.
- Participants who have children younger than three years old.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Institute for Financial Management and Research
Chennai, Tamil Nadu, 600006
J-PAL South Asia
Chennai, Tamil Nadu, 600006
About this study
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.
- Conditions
- Blood Pressure, Depression
- Being tested
- Naps, Home sleep aids, Sleep incentives
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapsOther
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 aidsDevice
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 incentivesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No changes to normal sleep habits. |
| Naps only | Experimental | 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. Receives: Other: Naps |
| Home sleep aids only | Experimental | 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. Receives: Device: Home sleep aids |
| Home sleep aids + Sleep incentives | Experimental | 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. Receives: Device: Home sleep aids; Other: Sleep incentives |
| Naps + Home sleep aids | Experimental | 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. Receives: Other: Naps; Device: Home sleep aids |
| Naps + Home sleep aids + Sleep incentives | Experimental | 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. Receives: Other: Naps; Device: Home sleep aids; Other: Sleep incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Per 24 Hours
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
Measured: Actigraphs are worn consistently throughout the study. The sleep per 24 hour period outcome is then measured every day through study completion, which is 28 business days (as well as intervening holidays and Sundays) for each participant.
Secondary outcomes (11)
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
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).
Measured: 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).
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).
Measured: 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).
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).
Measured: 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).
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).
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start23 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Financial Management and Research, Abdul Latif Jameel Poverty Action Lab, Government of Tamil Nadu, India
- Responsible party
- Principal investigator, Heather Schofield, University of Pennsylvania
- Investigators
- Gautam Rao, PhD, Principal investigator, Harvard UniversityFrank Schilbach, PhD, Principal investigator, Massachusetts Institute of TechnologyMargaret McConnell, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322358
- Sponsor's protocol ID
- 14-2294
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2017
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the de-identified data available upon request after publication.
Publications
Bessone P, Rao G, Schilbach F, Schofield H, Toma M. The Economic Consequences of Increasing Sleep Among the Urban Poor. Q J Econ. 2021 Apr 8;136(3):1887-1941. doi: 10.1093/qje/qjab013. eCollection 2021 Aug.
PubMed 34220361
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
- ClinicalTrials.gov ID
- NCT03322358
- Acronym / sponsor ID
- 14-2294
- Conditions
- Blood Pressure, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Institute for Financial Management and Research, Abdul Latif Jameel Poverty Action Lab, Government of Tamil Nadu, India
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No changes to normal sleep habits. |
| Naps only | Experimental | Other: NapsAfter 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 | Experimental | Device: Home sleep aidsAfter 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 | Experimental | Device: Home sleep aids, Other: Sleep incentivesAfter 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. |
| Naps + Home sleep aids | Experimental | Other: Naps, Device: Home sleep aidsAfter 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 + Home sleep aids + Sleep incentives | Experimental | Other: Naps, Device: Home sleep aids, Other: Sleep incentivesAfter 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NapsAfter a baseline period, participants in this condition will be provided with the opportunity to nap in a quiet comfortable "nap cabin" in the study office for 30 minutes each afternoon on all work days. | Other | Naps + Home sleep aids, Naps + Home sleep aids + Sleep incentives, Naps only |
| Home sleep aidsAfter a baseline period, participants in this condition will be provided with a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful. | Device | Home sleep aids + Sleep incentives, Home sleep aids only, Naps + Home sleep aids, Naps + Home sleep aids + Sleep incentives |
| Sleep incentivesAfter 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. | Other | Home sleep aids + Sleep incentives, Naps + Home sleep aids + Sleep incentives |
Primary outcome
Sleep Per 24 Hours
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.
Sleep is measured via actigraph. 24 hour sleep is the sum of night sleep and nap sleep.
11 secondary outcomes
Blood Pressure
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.
Depression
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.
Number of Days of Illness in Past Week
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.
Inhibitory Control
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).
Memory
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).
Attention
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).
Self-reported Pain
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.
Physical Fitness
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.
Activities of Daily Living
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.
Subjective Well-being
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.
Happiness
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34220361Bessone P, Rao G, Schilbach F, Schofield H, Toma M. The Economic Consequences of Increasing Sleep Among the Urban Poor. Q J Econ. 2021 Apr 8;136(3):1887-1941. doi: 10.1093/qje/qjab013. eCollection 2021 Aug.
- Individual participant dataSharing planned: Yes. We will make the de-identified data available upon request after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gautam Rao, PhD principal investigator
Harvard University
Frank Schilbach, PhD principal investigator
Massachusetts Institute of Technology
Margaret McConnell, PhD principal investigator
Harvard School of Public Health (HSPH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naps, Home sleep aids and Sleep incentives in people with Blood Pressure and Depression, run by University of Pennsylvania at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Per 24 Hours (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.