AzTrials
AzTrials

Delayed Sleep Phase SyndromeCARRS-P2NCT04792697

Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens

A study testing Increase morning bright light, Decrease evening blue light and Sleep Scheduling in people with Delayed Sleep Phase Syndrome, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times. Read more about this study

Who is it for?
Ages 13 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Delayed Sleep Phase Syndrome
What is being tested?
Increase morning bright light, Decrease evening blue light and Sleep Scheduling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteUnited States
Study dates
1 May 2021to 31 May 2026
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 13 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Typically enrolled in a traditional high-school with synchronous learning (in-person or online synchronous learning, but not cyber- or home-schooling) [school closures during the COVID-19 pandemic are an exception to this]
  • Physically and psychiatrically healthy
  • Provision of written informed consent and assent
  • Additional inclusion criterion for Experimental protocol: Meets operational definition of late sleep timing (>10:50PM habitual bedtime)

Who cannot join

  • History of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year
  • Significant or unstable acute or chronic medical conditions
  • Frequent headaches or migraines
  • History of seizures
  • Current serious psychiatric disorder (e.g., depressive disorder, bipolar disorder, eating disorder, psychotic disorder diagnosis, alcohol use disorder or substance use disorder) that would interfere with completion of study procedures
  • Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
Show all 12Show fewer
  • MRI contraindications (i.e., absence of metal in the body, claustrophobia)
  • Medications that increase sensitivity to blue light/photosensitizing medications, including psychiatric neuroleptic drugs, psoralen drugs, antiarrhythmic drugs, etc.
  • Changes to psychotropic medication regimen in the 2 weeks prior to enrollment, and/or major changes to medications during the study protocol
  • If participants have an average bedtime that is later than 3:00AM or an average wake time later than 11:00AM they may be excluded from the study
  • Participants should be EXCLUDED for other sleep disorders that require ongoing treatment
  • Participants should be EXCLUDED for other sleep disorders that cause significant distress or impairment, per DSM 5 criteria in the Sleep SCID.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Western Psychiatric Hospital

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Center for Adolescent Reward, Rhythms and Sleep Project 2

Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times. Many studies find that this increases the risk for substance use (SU). However, what impact circadian rhythm and sleep disruption either together or independently have on the neuronal circuitry that controls reward and cognition, or if there are interventions that might help to modify these disruptions is unknown. Project 2 (P2) of the CARRS center will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.

Read the detailed description

Substance use (SU) and substance use disorders (SUD) pose devastating health, financial, and societal costs. The incidence of SU and SUDs increases across adolescence, making this sensitive developmental period one of both heightened risk-and heightened opportunity for prevention and intervention. However, to develop effective interventions investigators need to identify novel and modifiable risk factors and mechanisms for SUD. Sleep and circadian rhythm disturbances are such risk factors, and the reward system, with its increasing sensitivity during adolescence, provides a plausible mechanistic substrate. The focus on sleep, circadian rhythms, and reward system function is particularly salient given the extensive, parallel development of these systems during adolescence, and the plausible linkages between sleep and circadian rhythms, reward function, and SUD risk.

Late sleep timing, short sleep duration and circadian misalignment are associated with increased substance use in teenagers and young adults. The central hypothesis of the Center for Adolescent Reward, Rhythms and Sleep (CARRS) is that adolescent development acts on underlying sleep and circadian traits to modify homeostatic sleep drive, circadian phase, and circadian alignment, which in turn impact cortico-limbic functions critical to SU risk (e.g., reward and cognitive control). Investigators further hypothesize that specific manipulations of sleep and circadian rhythms during adolescence will affect reward responsivity and cognitive control in either positive or negative directions. These manipulations will provide experimental support for our model, and proof of concept for novel clinical interventions to reduce the risk of SU and SUDs.

Most previous studies have examined individual components of circadian rhythms, sleep, and reward function in adolescence. Project 2 (P2) of CARRS will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs. Most notably, P2 improves upon past observational work by testing an experimental intervention that manipulates sleep and circadian rhythms to directly examine its impact on reward function and cognitive control.

P2 will study 150 adolescents (age 13-15, 50% female) across two key sleep phenotypes: early sleep timing (low risk, n=50) and late sleep timing (high risk, n=100). All participants will complete the observational study: 2 weeks of home sleep monitoring (actigraphy \& sleep diary), followed by an overnight laboratory visit to assess self-report, behavioral, and neuroimaging (fMRI) tasks tapping cognitive control and reward function, as well as circadian phase via salivary melatonin and molecular rhythms via hair follicles. The Late group will continue to the experimental study, each participant randomized to manipulation or attentional control conditions (n=50 each). Investigators will probe whether advancing sleep/circadian timing and extending sleep duration via sleep scheduling and chronotherapeutic approaches (reducing PM light exposure; administering AM bright light) improves sleep, circadian, and neurobehavioral function relevant to SUD risk. Finally, repeated 6-month follow-up assessments of sleep and SU for all participants are included to examine longitudinal associations.

Being tested
Increase morning bright light, Decrease evening blue light, Sleep Scheduling, Monitor sleep, mood, and substance use
Keywords
adolescence, sleep, substance use, reward sensitivity and motivation, circadian phase and alignment, inhibition
Medical subject headings
Sleep Disorders, Circadian Rhythm, Substance-Related Disorders, Inhibition, Psychological

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 upon rising

  • 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 bedtime by 1.5 hours and regularize their wake time

  • Monitor sleep, mood, and substance useBehavioural

    Participants will complete smartphone-based sleep, mood, and substance use monitoring

Study groups in NCT04792697
Study groupRoleWhat they receive
Advance/Extend ManipulationExperimentalFor ~2 weeks, Manipulation participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days and will be instructed to: * Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration) * Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed) * Increase morning bright light exposure via bright light goggles (30 min 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
ControlActive comparatorControl participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 12 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments and wear an actigraphy watch to monitor their sleep, behavior and sleep habits thereby controlling for effort.
Receives: Behavioral: Monitor sleep, mood, and substance use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weekday Sleep Duration--Actigraphy & Diaries

    Total Sleep Time as determined by wrist actigraphy data \& sleep diaries (averaged across weekdays during 2 weeks at T1 and 2 weeks at T2)

    Measured: Baseline (2 Weeks), T2 (2 weeks)

  2. Circadian Timing-Dim Light Melatonin Onset

    Circadian Timing as determined by dim light melatonin onset during saliva sampling using the 4pg/ml threshold.

    Measured: Baseline Overnight Visit (T1) & T2 Overnight Visit(2 weeks later). Always on a Friday.

  3. 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: Baseline overnight (T1), T2 overnight (2 weeks after T1)

  4. Reward motivation (Behavioral)

    Assessed by adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in which 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: Baseline overnight (T1) vs. T2 overnight (2 weeks after T1)

  5. Behavioral Inhibition

    Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue

    Measured: Baseline overnight (T1) vs. T2 overnight (2 weeks after T1). Always on a Friday.

  6. Neural correlates of Impulse control

    Activation within the Executive Control Network during the Stop Signal Task, a computerized an fMRI behavioral 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: Baseline overnight (T1) vs. T2 overnight (2 weeks after T1). Always on a Friday.

  7. Neural correlates of Reward Anticipation

    Activation within the reward network during the Monetary Incentive Delay task, a computerized an fMRI behavioral task. Specifially, 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: Baseline overnight (T1) vs. T2 overnight (2 weeks after T1). Always on a Friday.

  8. 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 & T2 (two weeks after T1)

Secondary outcomes (2)
  1. Cannabis use

    Days of cannabis use on Timeline Follow Back interview administered during the baseline interview and in self-report surveys every 6 months.

    Measured: Continuously every 6 months for up to 5 years

  2. Alcohol Use

    Days of alcohol use on Timeline Follow Back interview administered during baseline interview and every six months via self-report

    Measured: Continuously every 6 months for up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start1 May 2021
  3. Primary completion31 May 2026
  4. Study completion31 May 2026

Resources

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 \& Longitudinal protocols with 2 initial groups (Early Sleep Timing \& Late Sleep Timing). Both groups complete an initial laboratory protocol (baseline). The Late Sleep participants are also randomized to one of two arms (Manipulation or Control) in the experimental protocol (intervention). Early Sleep group does not complete the experimental protocol. Finally, all participants receive follow-up assessments through the life of the grant in the Longitudinal protocol.
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792697
Sponsor's protocol ID
STUDY20030271
Other IDs
1P50DA046346-01A1
Acronym
CARRS-P2
Status last verified
Apr 2026
First submitted
8 Mar 2021
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Current and future investigators, both internal and external, may have access to de-identified data; however only group data would be shared.

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 Syndrome, 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 4 inclusion and 12 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 8 Jul 2026. 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?

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?

Weekday Sleep Duration--Actigraphy & Diaries (time frame: Baseline (2 Weeks), T2 (2 weeks)). 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?
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 8 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in