Delayed Sleep PhaseNCT03806296
Delayed Sleep Timing in Teens Study
A study testing Increase morning bright light, Decrease evening blue light and Sleep scheduling in people with Delayed Sleep Phase, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will (1) comprehensively characterize the substance use disorder (SUD) risk profile associated with adolescent Delayed Sleep Phase (DSP), and (2) probe whether SUD risk is diminished by altering sleep/circadian timing. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Sleep Phase
- What is being tested?
- Increase morning bright light, Decrease evening blue light and Sleep scheduling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 30 Nov 2024
- 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-19 years
- Currently in 11th or 12th grade and enrolled in a traditional high-school; or cyber school with synchronous classes (not home-schooled)
- Physically and psychiatrically healthy, as determined by instruments described below
- Provision of written informed consent and assent
- Additional inclusion criterion for Experimental protocol
- Meets operational definition of delayed sleep phase (DSP; weekend bedtime ≥1 AM)
Who cannot join
- Significant or unstable acute or chronic medical conditions
- Past or current bipolar disorder or psychotic disorder
- Past or current substance use disorder other than alcohol use disorder or cannabis use disorder
- Past month recreational drug use other than alcohol, cannabis, and nicotine
- Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
- Medications that interfere with sleep and/or reward function (antidepressants, and stimulants prescribed for ADHD are permitted)
- Conditions that would interfere with the MRI procedures (e.g., non-removal ferromagnetic devices)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Delayed Sleep Phase and Risk for Adolescent Substance Use
This study will (1) comprehensively characterize the substance use disorder (SUD) risk profile associated with adolescent Delayed Sleep Phase (DSP), and (2) probe whether SUD risk is diminished by altering sleep/circadian timing.
Read the detailed description
Mounting evidence indicates that delayed sleep phase (DSP) may confer risk for adolescent substance use (SU) and SUDs. However, the exact nature of this link and the mechanisms underlying it remain unclear. Circadian misalignment, a mismatch between late sleep hours and early school start times, is a compelling potential contributor to elevated SU in adolescent DSP with plausible neurobehavioral mechanisms. The investigators hypothesize that DSP-associated circadian misalignment decreases impulse control and increases reward sensitivity, thereby increasing SUD risk.
This study will, for the first time, (1) comprehensively characterize the SUD risk profile associated with adolescent DSP, and (2) probe whether SUD risk is diminished by altering sleep/circadian timing. The study will assess both established markers of SUD risk and putative neurobehavioral mechanisms (impulsivity and reward sensitivity). Specifically, the investigators will employ a comprehensive, multi-method approach to examining DSP's role in SUD risk, combining laboratory, experimental, and longitudinal studies. The investigators will recruit a sample of 150 eleventh and twelfth graders (16-19 y/o), divided between 100 DSP and 50 normal phase teens. The investigators will focus on cannabis and alcohol use given their prevalent use in adolescents and evident links to DSP.
In the laboratory study, the investigators will compare a group of DSP adolescents to a group of normal phase adolescents on behavioral and neuroimaging (fMRI) tasks tapping impulsivity and reward sensitivity, as well as a circadian phase assessment.
In the experimental study, the investigators will probe whether stabilizing circadian phase in the DSP group (n=100) by using sleep scheduling and chronotherapeutic approaches (i.e., dim light in the evening and bright light in the morning) improves sleep and neurobehavioral function relevant to SUD risk.
NOTE: When this ClinicalTrials.gov protocol was initially submitted, there were some mistakes made. The initial submission focused only on the Experimental study, which thus only included the "DSP group" (aka Late Sleep Timing group), and thus out the Laboratory study along with the "normal phase group" (aka Early/Middle Sleep Timing group). At that time, we also only listed a limited range of the primary outcomes listed in the funded grant, inadvertently leaving out several primary outcomes (weekday sleep duration - actigraph, circadian timing - dim light melatonin onset, neural correlates of reward receipt, and baseline cannabis and alcohol use). Finally, we mistakenly listed cannabis use from the Longitudinal protocol as a secondary outcome when it was actually an exploratory outcome in the funded grant, and thus we removed it.
- Conditions
- Delayed Sleep Phase
- Being tested
- Increase morning bright light, Decrease evening blue light, Sleep scheduling, Monitor sleep, mood, and substance use
- Keywords
- sleep, circadian, adolescence, substance use, reward, impulse control
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase morning bright lightOther
Participants will wear Re-Timer bright glasses for 30 minutes each morning
Decrease evening blue lightOther
Participants will wear tinted glasses that block blue wavelength light for 2 hours before bed
Sleep schedulingBehavioural
Participants will advance their weekday bedtime and maintain their weekday risetime on weekends
Monitor sleep, mood, and substance useBehavioural
Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | Participants who reported a weekend bedtime ≥ 1 AM.
Completed both a 1-week baseline period (T1) and a 2-week experimental period (T2).
During the 2-week experimental period, participants were asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph Receives: Other: Increase morning bright light; Other: Decrease evening blue light; Behavioral: Sleep scheduling; Behavioral: Monitor sleep, mood, and substance use |
| Control | Active comparator | Participants who reported a weekend bedtime ≥ 1 AM.
Completed both a 1-week baseline period (T1) and a 2-week experimental period (T2).
During the 2-week experimental period, participants were asked to adhere to the following:
- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph Receives: Behavioral: Monitor sleep, mood, and substance use |
| Early/Middle Sleep Timing | No intervention | Participants who report a weekend bedtime <1AM. Participants completed only the 1-week baseline observational protocol (T1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekday Sleep Duration - Actigraphy
Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)
Measured: T1 (1 Week), T2 (2 Weeks)
Circadian Timing - Dim Light Melatonin Onset
Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Circadian Alignment
Circadian alignment is operationalized as the interval between the dim light melatonin onset (DLMO) and sleep midpoint based on the prior two nights of actigraphy data.
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday. Based on DLMO assessed on weeknight lab overnight visit, and including the two nights of actigraphy data prior to the lab visit.
Reward Motivation (Behavioral)
Adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button. The adjusted average only includes non-burst trials.
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Behavioral Inhibition
Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Neural Correlates of Reward Anticipation
Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signal in regions of the reward network (from NeuroSynth) on reward anticipation trials (large reward) versus neutral (no money) trials. Higher values represent increased reactivity to reward, as compared to neutral trials.
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Neural Correlates of Reward Receipt
Monetary Incentive Delay Task: Win Outcome vs No Win contrast within the reward network (from Neurosynth). Higher values represent increased reactivity to reward wins, as compared to neutral trials.
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Neural Correlates of Impulse Control
Activation within the Executive Control Network during the Stop Signal Task. Specifically, activation is defined as bold signal in regions of the Executive Control Network on unsuccessful Stop trials versus successful Go trials. Higher values represent increased activity to unsuccessful Stop versus successful Go trials.
Measured: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Cannabis Use
Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Measured: Days of cannabis use in 3 months prior to baseline.
Alcohol Use
Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Measured: 3 months prior to baseline, based on timeline followback interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start3 Dec 2018
- Primary completion22 Mar 2024
- Study completion30 Nov 2024
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 Delayed Sleep PhaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study combines Laboratory, Experimental, and Longitudinal protocols. The study includes 2 initial groups (Early/Middle Sleep Timing and Late Sleep Timing) that all complete the initial Laboratory (baseline) protocol. The Late Sleep participants are also randomized to complete one of two arms (Manipulation or Control) in the Experimental (intervention) protocol. The Early/Mid Sleep group does not complete the Experimental protocol. Finally, participants are also follow-up assessments through the life of the grant in the Longitudinal protocols.
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Brant Hasler, University of Pittsburgh
- Investigators
- Brant P Hasler, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806296
- Sponsor's protocol ID
- STUDY19030063
- Other IDs
- R01DA044143
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2019
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wescott DL, Quick AD, Oryshkewych NS, Wallace ML, Beebe D, Buysse DJ, Clark DB, Mirchandaney R, Hasler BP. Chronotherapeutic Approaches to Target Insufficient and Late Sleep in Adolescents: A Randomized Clinical Trial. JAMA Pediatr. 2026 Jun 1;180(6):610-618. doi: 10.1001/jamapediatrics.2026.0976.
PubMed 42008244
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Sleep Phase and Risk for Adolescent Substance Use
- ClinicalTrials.gov ID
- NCT03806296
- Acronym / sponsor ID
- STUDY19030063
- Conditions
- Delayed Sleep Phase
- Keywords
- sleep, circadian, adolescence, substance use, reward, impulse control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will (1) comprehensively characterize the substance use disorder (SUD) risk profile associated with adolescent Delayed Sleep Phase (DSP), and (2) probe whether SUD risk is diminished by altering sleep/circadian timing.
Detailed description
Mounting evidence indicates that delayed sleep phase (DSP) may confer risk for adolescent substance use (SU) and SUDs. However, the exact nature of this link and the mechanisms underlying it remain unclear. Circadian misalignment, a mismatch between late sleep hours and early school start times, is a compelling potential contributor to elevated SU in adolescent DSP with plausible neurobehavioral mechanisms. The investigators hypothesize that DSP-associated circadian misalignment decreases impulse control and increases reward sensitivity, thereby increasing SUD risk.
This study will, for the first time, (1) comprehensively characterize the SUD risk profile associated with adolescent DSP, and (2) probe whether SUD risk is diminished by altering sleep/circadian timing. The study will assess both established markers of SUD risk and putative neurobehavioral mechanisms (impulsivity and reward sensitivity). Specifically, the investigators will employ a comprehensive, multi-method approach to examining DSP's role in SUD risk, combining laboratory, experimental, and longitudinal studies. The investigators will recruit a sample of 150 eleventh and twelfth graders (16-19 y/o), divided between 100 DSP and 50 normal phase teens. The investigators will focus on cannabis and alcohol use given their prevalent use in adolescents and evident links to DSP.
In the laboratory study, the investigators will compare a group of DSP adolescents to a group of normal phase adolescents on behavioral and neuroimaging (fMRI) tasks tapping impulsivity and reward sensitivity, as well as a circadian phase assessment.
In the experimental study, the investigators will probe whether stabilizing circadian phase in the DSP group (n=100) by using sleep scheduling and chronotherapeutic approaches (i.e., dim light in the evening and bright light in the morning) improves sleep and neurobehavioral function relevant to SUD risk.
NOTE: When this ClinicalTrials.gov protocol was initially submitted, there were some mistakes made. The initial submission focused only on the Experimental study, which thus only included the "DSP group" (aka Late Sleep Timing group), and thus out the Laboratory study along with the "normal phase group" (aka Early/Middle Sleep Timing group). At that time, we also only listed a limited range of the primary outcomes listed in the funded grant, inadvertently leaving out several primary outcomes (weekday sleep duration - actigraph, circadian timing - dim light melatonin onset, neural correlates of reward receipt, and baseline cannabis and alcohol use). Finally, we mistakenly listed cannabis use from the Longitudinal protocol as a secondary outcome when it was actually an exploratory outcome in the funded grant, and thus we removed it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study combines Laboratory, Experimental, and Longitudinal protocols. The study includes 2 initial groups (Early/Middle Sleep Timing and Late Sleep Timing) that all complete the initial Laboratory (baseline) protocol. The Late Sleep participants are also randomized to complete one of two arms (Manipulation or Control) in the Experimental (intervention) protocol. The Early/Mid Sleep group does not complete the Experimental protocol. Finally, participants are also follow-up assessments through the life of the grant in the Longitudinal protocols.
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Other: Increase morning bright light, Other: Decrease evening blue light, Behavioral: Sleep scheduling, Behavioral: Monitor sleep, mood, and substance useParticipants who reported a weekend bedtime ≥ 1 AM. Completed both a 1-week baseline period (T1) and a 2-week experimental period (T2). During the 2-week experimental period, participants were asked to adhere to the following: * Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration) * Decrease evening blue light exposure via blue blocker goggles (2 h before bed) * Increase morning bright light exposure via bright light goggles (30 m after rise) * Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph |
| Control | Active comparator | Behavioral: Monitor sleep, mood, and substance useParticipants who reported a weekend bedtime ≥ 1 AM. Completed both a 1-week baseline period (T1) and a 2-week experimental period (T2). During the 2-week experimental period, participants were asked to adhere to the following: - Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph |
| Early/Middle Sleep Timing | No intervention | –Participants who report a weekend bedtime <1AM. Participants completed only the 1-week baseline observational protocol (T1) |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 16-19 years
- Currently in 11th or 12th grade and enrolled in a traditional high-school; or cyber school with synchronous classes (not home-schooled)
- Physically and psychiatrically healthy, as determined by instruments described below
- Provision of written informed consent and assent
- Additional inclusion criterion for Experimental protocol
Key exclusion criteria (7 listed)
- Significant or unstable acute or chronic medical conditions
- Past or current bipolar disorder or psychotic disorder
- Past or current substance use disorder other than alcohol use disorder or cannabis use disorder
- Past month recreational drug use other than alcohol, cannabis, and nicotine
- Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
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 |
|---|---|---|
| Increase morning bright lightParticipants will wear Re-Timer bright glasses for 30 minutes each morning | Other | Manipulation |
| Decrease evening blue lightParticipants will wear tinted glasses that block blue wavelength light for 2 hours before bed | Other | Manipulation |
| Sleep schedulingParticipants will advance their weekday bedtime and maintain their weekday risetime on weekends | Behavioural | Manipulation |
| Monitor sleep, mood, and substance useParticipants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy | Behavioural | Control, Manipulation |
Primary outcome
Weekday Sleep Duration - Actigraphy
Time frame: T1 (1 Week), T2 (2 Weeks)
Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)
Circadian Timing - Dim Light Melatonin Onset
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.
Circadian Alignment
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday. Based on DLMO assessed on weeknight lab overnight visit, and including the two nights of actigraphy data prior to the lab visit.
Circadian alignment is operationalized as the interval between the dim light melatonin onset (DLMO) and sleep midpoint based on the prior two nights of actigraphy data.
Reward Motivation (Behavioral)
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button. The adjusted average only includes non-burst trials.
Behavioral Inhibition
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue
Neural Correlates of Reward Anticipation
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signal in regions of the reward network (from NeuroSynth) on reward anticipation trials (large reward) versus neutral (no money) trials. Higher values represent increased reactivity to reward, as compared to neutral trials.
Neural Correlates of Reward Receipt
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Monetary Incentive Delay Task: Win Outcome vs No Win contrast within the reward network (from Neurosynth). Higher values represent increased reactivity to reward wins, as compared to neutral trials.
Neural Correlates of Impulse Control
Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Activation within the Executive Control Network during the Stop Signal Task. Specifically, activation is defined as bold signal in regions of the Executive Control Network on unsuccessful Stop trials versus successful Go trials. Higher values represent increased activity to unsuccessful Stop versus successful Go trials.
Cannabis Use
Time frame: Days of cannabis use in 3 months prior to baseline.
Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Alcohol Use
Time frame: 3 months prior to baseline, based on timeline followback interview.
Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42008244Wescott DL, Quick AD, Oryshkewych NS, Wallace ML, Beebe D, Buysse DJ, Clark DB, Mirchandaney R, Hasler BP. Chronotherapeutic Approaches to Target Insufficient and Late Sleep in Adolescents: A Randomized Clinical Trial. JAMA Pediatr. 2026 Jun 1;180(6):610-618. doi: 10.1001/jamapediatrics.2026.0976.
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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.
Brant P Hasler, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase morning bright light, Decrease evening blue light and Sleep scheduling in people with Delayed Sleep Phase, run by University of Pittsburgh at 1 site in United States.
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 6 inclusion and 7 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 26 Aug 2025. 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 United States. 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 26 Aug 2025). 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?
Weekday Sleep Duration - Actigraphy (time frame: T1 (1 Week), T2 (2 Weeks)). The study lists 10 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 NCT03806296, 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 26 Aug 2025.