Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT05336084

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

Interventions

Ultradian sleep/wake protocol

Study Details

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

Study ID

NCT05336084

Start date

Mar 4, 2022

Status verified date

Apr, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ultradian Sleep/Wake protocol

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.

Interventions

Ultradian sleep/wake protocol

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

Primary outcome measure

  • Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol. [ Time Frame: 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 [ Time Frame: Every 2 hours during the ultradian sleep/wake protocol, up two 36 hours ]
  • Melatonin onset [ Time Frame: The first 28-hours of the ultradian sleep/wake protocol ]

Central Contacts and Locations

Central contacts

Ronette Blake, MS

(412) 443-3704blakerg2@upmc.edu

Sarah Aerni

412-551-110aernise2@upmc.edu

Locations

Western Psychiatric Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Ronette Blake, MS

412-443-3704blakerg2@upmc.edu

Principal Investigator:

Peter L. Franzen, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-08.