Delayed Sleep Timing in Teens Study

Not Applicable

Completed

• Conditions: Delayed Sleep Phase
• Interventions: Other: Increase morning bright light; Other: Decrease evening blue light; Behavioral: Sleep scheduling; Behavioral: Monitor sleep, mood, and substance use

• Registration Number: NCT03806296
• Lead Sponsor: University of Pittsburgh

Brief 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.

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 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.

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Primary Completion: 2024-03-22
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manipulation	Increase morning bright light	For \~2 weeks, participants will be 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
Manipulation	Sleep scheduling	For \~2 weeks, participants will be 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
Manipulation	Monitor sleep, mood, and substance use	For \~2 weeks, participants will be 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	Monitor sleep, mood, and substance use	For \~2 weeks, participants will asked to adhere to the following: - Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Manipulation	Decrease evening blue light	For \~2 weeks, participants will be 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

Primary Outcome Measures

Name	Time	Method
Reward motivation (behavioral)	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)	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.
Neural correlates of reward anticipation	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)	Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signals in regions of the reward network (particularly the ventral striatum) on reward anticipation trials versus no money trials.
Circadian alignment	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)	Interval between dim light melatonin onset and midsleep
Behavioral inhibition	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)	Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on go trials with no/go target
Neural correlates of impulse control	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)	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 (particularly the inferior frontal gyrus) on correct Stop trials versus correct Go trials.

Secondary Outcome Measures

Name	Time	Method
Cannabis use	During follow-ups after the manipulation through study completion, up to 5 years	Cannabis use on Time Line Follow Back interview. Specifically, the frequency (# of days) of cannabis use (yes/no) in the past 2 months.

Trial Locations

Locations (1)

Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States