NCT05336084 · University of Pittsburgh
Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents
(CARRS-P1)
What this study is about
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).
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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 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.
Change in slope of waking EEG theta power
Time frame: Every 2 hours during the ultradian sleep/wake protocol, up two 36 hours
Assessed every 2 hours across the ultradian sleep/wake protocol
Melatonin onset
Time frame: The first 28-hours of the ultradian sleep/wake protocol
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
Where
- Pittsburgh, Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations