Delayed Sleep Timing in Teens Study

NCT ID: NCT03806296

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2024-11-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Manipulation

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

Group Type: EXPERIMENTAL

Increase morning bright light

Intervention Type: OTHER

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

Decrease evening blue light

Intervention Type: OTHER

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

Sleep scheduling

Intervention Type: BEHAVIORAL

Participants will advance their weekday bedtime and maintain their weekday risetime on weekends

Monitor sleep, mood, and substance use

Intervention Type: BEHAVIORAL

Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy

Control

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

Group Type: ACTIVE_COMPARATOR

Monitor sleep, mood, and substance use

Intervention Type: BEHAVIORAL

Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy

Early/Middle Sleep Timing

Participants who report a weekend bedtime \<1AM. Participants completed only the 1-week baseline observational protocol (T1)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Increase morning bright light

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

Intervention Type: OTHER

Decrease evening blue light

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

Intervention Type: OTHER

Sleep scheduling

Participants will advance their weekday bedtime and maintain their weekday risetime on weekends

Intervention Type: BEHAVIORAL

Monitor sleep, mood, and substance use

Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Brant Hasler

Assistant Professor of Psychiatry, Psychology, and Clinical and Translational Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brant P Hasler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA044143

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19030063

Identifier Type: -

Identifier Source: org_study_id