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

NCT04792697 | Recruiting

• 2 other identifiers: STUDY200302711P50DA046346-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Delayed Sleep Phase Syndrome

Keywords

adolescence; sleep; substance use; reward sensitivity and motivation; circadian phase and alignment; inhibition

Outcome Measures

Primary Outcomes (8)

• 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)

  Baseline (2 Weeks), T2 (2 weeks)

• Circadian Timing-Dim Light Melatonin Onset

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

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

• 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.

  Baseline overnight (T1), T2 overnight (2 weeks after T1)

• 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.

  Baseline overnight (T1) vs. T2 overnight (2 weeks after T1)

• Behavioral Inhibition

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

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

• 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.

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

• 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.

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

• 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.

  Overnight visits at end of T1 & T2 (two weeks after T1)

Secondary Outcomes (2)

• Cannabis use

  Continuously every 6 months for up to 5 years

• Alcohol Use

  Continuously every 6 months for up to 5 years

Study Arms (2)

Advance/Extend Manipulation

EXPERIMENTAL

For \~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

Other: Increase morning bright light; Other: Decrease evening blue light; Behavioral: Sleep Scheduling; Behavioral: Monitor sleep, mood, and substance use

Control

ACTIVE COMPARATOR

Control 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.

Behavioral: Monitor sleep, mood, and substance use

Interventions

Increase morning bright light OTHER

Participants will wear Re-Timer bright glasses for 30 minutes each morning upon rising

Advance/Extend Manipulation

Decrease evening blue light OTHER

Participants will wear tinted glasses that block blue wavelength light for 2 hours before bed

Advance/Extend Manipulation

Sleep Scheduling BEHAVIORAL

Participants will advance their bedtime by 1.5 hours and regularize their wake time

Advance/Extend Manipulation

Monitor sleep, mood, and substance use BEHAVIORAL

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

Advance/Extend Manipulation; Control

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Substance-Related Disorders; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Chemically-Induced Disorders; Behavior

Study Officials

• Brant Hasler, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronette G Blake, MS

CONTACT

(412) 246-6443; blakerg2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Psychology and Clinical and Translational Science

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)