Sleep DeprivationNCT02838095
Effects of Napping in Sleep-Restricted Adolescents
A study testing Nap in people with Sleep Deprivation and Sleep, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
To examine the neurobehavioural responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and no-nap groups. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep
- What is being tested?
- Nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy
- no sleep disorder
- body mass index not greater than 30
Who cannot join
- smoker
- habitual short sleeper (time in bed during term time of less than 6 hours and no sign of sleep extension of greater than 1 hour on weekends)
- consumption of more than 5 cups of caffeinated beverages a day
- travelling across more than 2 time zones in the month prior to the study protocol
- diagnosed with any psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Daytime Nap on Alleviating Cognitive Impairment Due to Short Sleep in Adolescents
To examine the neurobehavioural responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15 days. The nap group received an afternoon sleep opportunity lasting 1 hour.
Read the detailed description
57 participants (aged 15 to 19 years old) were grouped into nap and no nap groups. Both groups took part in a 15-day protocol that started with 2 9-hour adaptation and baseline nights, followed by two successive cycles of sleep restriction (5-h time-in-bed [TIB]; 01:00-06:00) and recovery (9-h TIB; 23:00-08:00) intended to simulate the weekday sleep loss and weekend attempt to 'catch up' that are familiar to high school students. The nap group received a 1-hour nap opportunity at 14:00 following each sleep-restricted night, while participants in the no nap group watched a documentary. Sleep was monitored with polysomnography on 9 selected nights. Cognitive performance, subjective sleepiness, and mood were assessed 3 times daily (10:00, 15:45, and 20:00).
All participants stayed in air-conditioned, twin-share bedrooms with en-suite bathrooms. Bedroom windows were fitted with blackout panels to ensure participants were not woken up prematurely by sunlight. Earplugs were also provided, and participants were allowed to adjust the temperature of their bedrooms to their personal comfort. 3 main meals were served each day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and strenuous physical activities were prohibited.
Outside of scheduled sleep, meal, and cognitive testing times, participants spent the majority of their free time in a common room that was illuminated by natural and artificial lighting. They were allowed to read, play non-physically exerting games, watch videos, and interact with research staff and other participants. Participants were under constant supervision by the research staff.
- Conditions
- Sleep Deprivation, Sleep
- Being tested
- Nap
- Keywords
- nap, sleep restriction, recovery sleep, cognitive performance, subjective sleepiness, mood, neurobehavioural functions
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapBehavioural
A 1-hour daytime nap opportunity
| Study group | Role | What they receive |
|---|---|---|
| No nap | No intervention | After each night with a 5-hour sleep opportunity, participants did not have a daytime nap opportunity, but instead watched documentaries. |
| Nap | Experimental | After each night with a 5-hour sleep opportunity, participants had the chance to take a daytime nap from 14:00 to 15:00. Receives: Behavioral: Nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sustained attention assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Number of attention lapses (>500ms)
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in working memory assessed with the 1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Number of correct responses in the 1-back task
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in executive functions assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Number of correct responses in the 3-back task
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in the level of subjective sleepiness assessed with the Karolinska Sleepiness Scale from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Score on the Karolinska Sleepiness Scale (1-9 points)
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in positive mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Total score on the positive subscale of the PANAS
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in negative mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Total score on the negative subscale of the PANAS
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in speed of processing assessed with the Mental Arithmetic Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Number of correct responses in the task
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Change in speed of processing assessed with the Symbol Digit Modalities Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Number of correct responses in the task
Measured: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Secondary outcomes (10)
Change in total sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Total duration of nocturnal sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
Measured: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in N1 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Duration of nocturnal N1 sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
Measured: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in N2 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Duration of nocturnal N2 sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
Measured: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in N3 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Duration of nocturnal N3 sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
Measured: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in REM sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Duration of nocturnal REM sleep was determined to establish baseline sleep characteristics (first and third nights) and changes in the first sleep restriction period (fourth, sixth and eighth night), the first recovery period (ninth night), the second sleep restriction period (eleventh and thirteenth night), and the second recovery period (fourteenth night).
Measured: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in total sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Total duration of sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in N1 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Duration of N1 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in N2 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Duration of N2 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in N3 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Duration of N3 sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in REM sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Duration of REM sleep during the selected nap episodes was determined to track changes in this parameter from the first sleep restriction period (fourth, sixth and eighth day) to the second sleep restriction period (eleventh and thirteenth day).
Measured: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Michael WL Chee, MBBS, Duke-NUS Graduate Medical School
- Investigators
- Michael WL Chee, MBBS, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838095
- Sponsor's protocol ID
- NFS2
- Status last verified
- Jul 2016
- First submitted
- 15 Jun 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lo JC, Ang JWA, Koa TB, Ong JL, Lim J. Predicting vigilance vulnerability during 1 and 2 weeks of sleep restriction with baseline performance metrics. Sleep Adv. 2022 Oct 25;3(1):zpac040. doi: 10.1093/sleepadvances/zpac040. eCollection 2022.
PubMed 37193393Lo JC, Koa TB, Ong JL, Gooley JJ, Chee MWL. Staying vigilant during recurrent sleep restriction: dose-response effects of time-in-bed and benefits of daytime napping. Sleep. 2022 Apr 11;45(4):zsac023. doi: 10.1093/sleep/zsac023.
PubMed 35089345
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Daytime Nap on Alleviating Cognitive Impairment Due to Short Sleep in Adolescents
- ClinicalTrials.gov ID
- NCT02838095
- Acronym / sponsor ID
- NFS2
- Conditions
- Sleep Deprivation, Sleep
- Keywords
- nap, sleep restriction, recovery sleep, cognitive performance, subjective sleepiness, mood, neurobehavioural functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the neurobehavioural responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15 days. The nap group received an afternoon sleep opportunity lasting 1 hour.
Detailed description
57 participants (aged 15 to 19 years old) were grouped into nap and no nap groups. Both groups took part in a 15-day protocol that started with 2 9-hour adaptation and baseline nights, followed by two successive cycles of sleep restriction (5-h time-in-bed [TIB]; 01:00-06:00) and recovery (9-h TIB; 23:00-08:00) intended to simulate the weekday sleep loss and weekend attempt to 'catch up' that are familiar to high school students. The nap group received a 1-hour nap opportunity at 14:00 following each sleep-restricted night, while participants in the no nap group watched a documentary. Sleep was monitored with polysomnography on 9 selected nights. Cognitive performance, subjective sleepiness, and mood were assessed 3 times daily (10:00, 15:45, and 20:00).
All participants stayed in air-conditioned, twin-share bedrooms with en-suite bathrooms. Bedroom windows were fitted with blackout panels to ensure participants were not woken up prematurely by sunlight. Earplugs were also provided, and participants were allowed to adjust the temperature of their bedrooms to their personal comfort. 3 main meals were served each day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and strenuous physical activities were prohibited.
Outside of scheduled sleep, meal, and cognitive testing times, participants spent the majority of their free time in a common room that was illuminated by natural and artificial lighting. They were allowed to read, play non-physically exerting games, watch videos, and interact with research staff and other participants. Participants were under constant supervision by the research staff.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No nap | No intervention | –After each night with a 5-hour sleep opportunity, participants did not have a daytime nap opportunity, but instead watched documentaries. |
| Nap | Experimental | Behavioral: NapAfter each night with a 5-hour sleep opportunity, participants had the chance to take a daytime nap from 14:00 to 15:00. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- healthy
- no sleep disorder
- body mass index not greater than 30
Key exclusion criteria (5 listed)
- smoker
- habitual short sleeper (time in bed during term time of less than 6 hours and no sign of sleep extension of greater than 1 hour on weekends)
- consumption of more than 5 cups of caffeinated beverages a day
- travelling across more than 2 time zones in the month prior to the study protocol
- diagnosed with any psychiatric conditions
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 |
|---|---|---|
| NapA 1-hour daytime nap opportunity | Behavioural | Nap |
Primary outcome
Change in sustained attention assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Number of attention lapses (>500ms)
Change in working memory assessed with the 1-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Number of correct responses in the 1-back task
Change in executive functions assessed with the 3-back task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Number of correct responses in the 3-back task
Change in the level of subjective sleepiness assessed with the Karolinska Sleepiness Scale from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Score on the Karolinska Sleepiness Scale (1-9 points)
Change in positive mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Total score on the positive subscale of the PANAS
Change in negative mood assessed with the Positive and Negative Affect Scale (PANAS) from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Total score on the negative subscale of the PANAS
Change in speed of processing assessed with the Mental Arithmetic Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Number of correct responses in the task
Change in speed of processing assessed with the Symbol Digit Modalities Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery
Time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days
Number of correct responses in the task
10 secondary outcomes
Change in total sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Time frame: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in N1 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Time frame: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in N2 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Time frame: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in N3 sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Time frame: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in REM sleep duration at night assessed with polysomnography from baseline nights to the first and second cycles of sleep restriction and recovery
Time frame: Nocturnal sleep on nights 1 & 3 (baseline), 4, 6 & 8 (first sleep restriction period), 9 (first recovery period), 11 & 13 (second sleep restriction period), & 14 (second recovery period)
Change in total sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Time frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in N1 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Time frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in N2 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Time frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in N3 sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Time frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Change in REM sleep duration during daytime naps assessed with polysomnography from the first to the second sleep restriction period
Time frame: Afternoon naps on days 4, 6 & 8 (first sleep restriction period), 11 & 13 (second sleep restriction period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 37193393Lo JC, Ang JWA, Koa TB, Ong JL, Lim J. Predicting vigilance vulnerability during 1 and 2 weeks of sleep restriction with baseline performance metrics. Sleep Adv. 2022 Oct 25;3(1):zpac040. doi: 10.1093/sleepadvances/zpac040. eCollection 2022.
- Derived from this study: PubMed 35089345Lo JC, Koa TB, Ong JL, Gooley JJ, Chee MWL. Staying vigilant during recurrent sleep restriction: dose-response effects of time-in-bed and benefits of daytime napping. Sleep. 2022 Apr 11;45(4):zsac023. doi: 10.1093/sleep/zsac023.
- Individual participant dataSharing planned: No
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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.
Michael WL Chee, MBBS principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap in people with Sleep Deprivation and Sleep, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 3 inclusion and 5 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in sustained attention assessed with the Psychomotor Vigilance Task from morning to afternoon and then evening from baseline days to the first and second cycles of sleep restriction and recovery (time frame: 3 times daily (10:00, 15:45, and 20:00) for 15 days). The study lists 8 primary outcomes in all. 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 NCT02838095, which also lists 2 linked publications.
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 20 Jul 2016.