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

Center for Adolescent Reward, Rhythms and Sleep Project 1

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05336084
Acronym
CARRS-P1
Enrollment
200
Registered
2022-04-20
Start date
2022-03-04
Completion date
2030-05-31
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

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

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.

Detailed description

P1 will study 200 adolescents ages 13-18 in a 48-h to 60-h laboratory study. Participants will monitor sleep patterns at home for 2 weeks with actigraphy and sleep diary, and will also complete fMRI measures of reward and cognitive control. This will be followed by a 48-to-60-hour laboratory visit. The laboratory session includes two nights of polysomnography (PSG) sleep studies (the second night of PSG was halted for all participants as of January 2026), separated by 28 h of an ultradian sleep/wake protocol-every 120-minutes, there will be an 80-minute period of waking, followed by a 40-minute sleep opportunity. (Prior to January 2026, participants had a 36-h ultradian sleep/wake protocol, which was then shortened to 28 hours). Participants will be in dim light conditions and temporal isolation for the first 28 h of the ultradian sleep/wake protocol. Physiological circadian measures include salivary melatonin; core body temperature (CBT); and molecular rhythms from hair follicle cells (examined in Project 3). Physiological sleep homeostatic measures include waking EEG theta power, slow-wave sleep rebound following the ultradian sleep/wake protocol (for participants enrolled prior to January 2026), and repeated sleep latency on the sleep opportunities. Behavioral tests (Reward Anti-Saccade task to index cognitive control with/without reward modulation; Psychomotor Vigilance Test) and self-reports of mood/sleepiness will be collected every 2 h. Longitudinal on-line surveys will assess substance use every 6 months for the life of the grant.

Interventions

BEHAVIORALUltradian sleep/wake protocol

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

Sponsors

University of Pittsburgh
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.The first night of sleep preceding the 36-hour ultradian sleep/wake protocol vs the night of sleep following the ultradian sleep/wake protocolChange 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 powerEvery 2 hours during the ultradian sleep/wake protocol, up two 36 hoursAssessed every 2 hours across the ultradian sleep/wake protocol
Melatonin onsetThe first 28-hours of the ultradian sleep/wake protocolEndogenous 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.

Secondary

MeasureTime frameDescription
Circadian pattern of Core Body Temperature (CBT)Measured continuously across the ultradian sleep/wake protocol, up two 36 hours.Minimum of CBT
Melatonin amplitudeCollected every 30-60 minutes across the ultradian sleep/wake protocol, up two 36 hoursAmplitude of the 24-hour melatonin period to estimate endogenous circadian phase
Sleep latencyDuring the 40-minute sleep opportunities collected every two hours across the ultradian sleep/wake protocol, up two 36 hoursTime until sleep onset (first 30-second epoch of N2 sleep) as assessed by polysomnography
Influence of sleep and circadian measures on neural correlates of impulse controlMeasures from the ultradian sleep/wake protocol in relation to an fMRI scan measured 1 to 2 weeks earlier.This outcome will be measured during the Stop Signal Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the Executive Control Network, specifically, activation is defined as bold signal in regions of the Executive Control Network (particularly the inferior frontal gyrus) on correct Stop trials versus correct Go trials.
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.This outcome will be measured during the Money Incentive Delay Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the reward network, specifically, activation is defined as bold signals in regions of the reward network (particularly the ventral striatum) on reward anticipation trials versus no money trials.
Performance on the Psychomotor Vigilance TaskCollected every 2 hours during the ultradian sleep/wake protocol, up two 36 hours.This outcome will be measured during the Psychomotor Vigilance Task, specifically lapses (reaction times \> 500 ms) on this sustained attention task.
Performance on the Reward Anti-Saccade taskCollected every two hours during the ultradian sleep/wake protocol, up two 36 hours.This outcome will be measured during the Reward Anti-Saccade task, which measures the ability to look away from a target (an anti-saccade).
Substance useEvery 6 months for the duration of the study, up to 4.5 yearsFrequency-based self-reports of substance use.

Countries

United States

Contacts

CONTACTRonette Blake, MS
blakerg2@upmc.edu(412) 443-3704
CONTACTSarah Aerni
aernise2@upmc.edu412-551-110
PRINCIPAL_INVESTIGATORPeter L. Franzen, PhD

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026