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NCT Number: NCT05336084

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

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Peter L. Franzen, PhD

PRINCIPAL_INVESTIGATOR

Ronette Blake, MS

CONTACT

[email protected]

412-443-3704

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Circadian pattern of Core Body Temperature (CBT)

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

    Minimum of CBT

  2. Melatonin amplitude

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

    Amplitude of the 24-hour melatonin period to estimate endogenous circadian phase

  3. Sleep latency

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

    Time until sleep onset (first 30-second epoch of N2 sleep) as assessed by polysomnography

  4. Influence of sleep and circadian measures on neural correlates of impulse control

    Time frame: Measures 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.

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

    Time frame: 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.

  6. Performance on the Psychomotor Vigilance Task

    Time frame: Collected 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.

  7. Performance on the Reward Anti-Saccade task

    Time frame: Collected 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).

  8. Substance use

    Time frame: Every 6 months for the duration of the study, up to 4.5 years

    Frequency-based self-reports of substance use.

Study contacts

Contact information is provided by the study sponsor or research team.

Ronette Blake, MS

CONTACT

[email protected]

(412) 443-3704

Sarah Aerni

CONTACT

[email protected]

412-551-110

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Center for Adolescent Reward, Rhythms and Sleep Project 1

Acronym: CARRS-P1

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 20, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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