Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents

NCT05336084 | Recruiting

• 2 other identifiers: STUDY20030237P50DA046346
• Study Type: interventional
• Target: 200
• 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, which may increase 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 1 (P1), specifically examines homeostatic and circadian characteristics as mechanisms linking habitual sleep patterns, reward and cognitive control (at subjective, behavioral, and circuit levels), and longitudinal substance use risk.

Conditions

Sleep

Keywords

adolescence; sleep; substance use; reward sensitivity and motivation; circadian phase and alignment; homeostatic sleep drive; ultradian sleep/wake schedule

Outcome Measures

Primary Outcomes (3)

• Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.

  Change in the slope of EEG delta power (0.5 - 4 Hz) across NREM periods (frontal leads) on the night preceding vs. following the 36-h ultradian sleep/wake protocol (as measured by polysomnography). This procedure is no longer being collected as of January 2026.

  The first night of sleep preceding the 36-hour ultradian sleep/wake protocol vs the night of sleep following the ultradian sleep/wake protocol

• Change in slope of waking EEG theta power

  Assessed every 2 hours across the ultradian sleep/wake protocol

  Every 2 hours during the ultradian sleep/wake protocol, up two 36 hours

• Melatonin onset

  Endogenous circadian phase estimate of the rise in evening melatonin levels from saliva samples collected over the ultradian protocol (every 30 - 60 minutes) under dim light conditions.

  The first 28-hours of the ultradian sleep/wake protocol

Secondary Outcomes (8)

• Circadian pattern of Core Body Temperature (CBT)

  Measured continuously across the ultradian sleep/wake protocol, up two 36 hours.

• Melatonin amplitude

  Collected every 30-60 minutes across the ultradian sleep/wake protocol, up two 36 hours

• Sleep latency

  During the 40-minute sleep opportunities collected every two hours across the ultradian sleep/wake protocol, up two 36 hours

• Influence of sleep and circadian measures on neural correlates of impulse control

  Measures from the ultradian sleep/wake protocol in relation to an fMRI scan measured 1 to 2 weeks earlier.

• Influence of sleep and circadian measures on neural correlates of reward anticipation and reward outcome.

  1 to 2 weeks before to immediately after the ultradian sleep/wake protocol.

Study Arms (1)

Ultradian Sleep/Wake protocol

EXPERIMENTAL

This study uses an ultradian sleep/wake protocol to examine circadian and homeostatic sleep systems and their contributions to reward and cognitive control function. All participants will undergo the ultradian sleep/wake protocol following a night of sleep in the lab (measured with polysomnography). The ultradian sleep/wake protocol will last for 28-36 h, during which every 120-minutes, there will be an 80-minute period of waking, followed by a 40-minute sleep opportunity. Prior to 2026, a repeat night of sleep will occur at the end of the 36-hour ultradian sleep/wake protocol. As of 2026, the repeat sleep study is no longer being conducted, and the ultradian protocol was shortened to 28 hours.

Behavioral: Ultradian sleep/wake protocol

Interventions

Ultradian sleep/wake protocol BEHAVIORAL

120-minute schedule, consisting of 80 minutes awake followed by a 40 minute sleep opportunity for up to 36 hours

Ultradian Sleep/Wake protocol

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 13-18 years
• Currently enrolled in a traditional high-school (not cyber- or home-schooled) \[school closures during the COVID-19 pandemic are an exception to this\]
• Physically and psychiatrically healthy
• Provision of written informed consent and assent

You may not qualify if:

• outside age range above
• have a history of alcohol, cannabis, or illicit drug use greater than weekly use in the past year
• have serious medical or neurological disorders, including history of seizures
• have serious psychiatric disorders (e.g. bipolar disorder and schizophrenia)
• taking antidepressants (SSRIs/SSNIs are OK) or medications known to impact sleep/wake function - some medications may be okay if willing and able to discontinue prior to and/or for laboratory procedures
• have sleep disorders other than insomnia or Delayed Sleep Phase Disorder
• have MRI contraindications (i.e., metal in the body; claustrophobia)
• first degree relative with bipolar disorder
• frequent headaches or migraines
• inability to swallow pills/capsules.
• pregnancy
• participants with observed Obstructive Sleep Apnea via Apnealink, as indicated by an Apnea Hypopnea Index (AHI) of greater than 5
• Less than 80 lbs. or a BMI of greater than 35

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

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Peter L. Franzen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronette Blake, MS

CONTACT

(412) 443-3704; blakerg2@upmc.edu

Sarah Aerni

CONTACT

412-551-110; aernise2@upmc.edu

Study Design

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

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: April 20, 2022
• Study Start: March 4, 2022
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)