CompletedNot Applicable

Delayed Sleep Timing in Teens Study

United States142 participantsStarted 2018-12-03

Plain-language 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.

Who can participate

Age range

16 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weekday Sleep Duration - Actigraphy

Timeframe: T1 (1 Week), T2 (2 Weeks)

Circadian Timing - Dim Light Melatonin Onset

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Circadian Alignment

Timeframe: 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)

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Behavioral Inhibition

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Neural Correlates of Reward Anticipation

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Trial details

NCT IDNCT03806296

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-22

Results submitted2025-07-08

View on ClinicalTrials.gov More Delayed Sleep Phase trials

Who can participate

Age range

16 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Weekday Sleep Duration - Actigraphy

Timeframe: T1 (1 Week), T2 (2 Weeks)

Circadian Timing - Dim Light Melatonin Onset

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Circadian Alignment

Reward Motivation (Behavioral)

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Behavioral Inhibition

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Neural Correlates of Reward Anticipation

Timeframe: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.