SleepCARRS-P1NCT05336084
Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents
A study testing Ultradian sleep/wake protocol in people with Sleep, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Ultradian sleep/wake protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
Ronette Blake, MS, 412-443-3704, blakerg2@upmc.edu
Peter L. Franzen, PhD
About this study
Official title: Center for Adolescent Reward, Rhythms and Sleep Project 1
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Ultradian sleep/wake protocol
- Keywords
- adolescence, sleep, substance use, reward sensitivity and motivation, circadian phase and alignment, homeostatic sleep drive, ultradian sleep/wake schedule
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultradian sleep/wake protocolBehavioural
120-minute schedule, consisting of 80 minutes awake followed by a 40 minute sleep opportunity for up to 36 hours
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Ultradian sleep/wake protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: The first 28-hours of the ultradian sleep/wake protocol
Secondary outcomes (8)
Circadian pattern of Core Body Temperature (CBT)
Minimum of CBT
Measured: Measured continuously across the ultradian sleep/wake protocol, up two 36 hours.
Melatonin amplitude
Amplitude of the 24-hour melatonin period to estimate endogenous circadian phase
Measured: Collected every 30-60 minutes across the ultradian sleep/wake protocol, up two 36 hours
Sleep latency
Time until sleep onset (first 30-second epoch of N2 sleep) as assessed by polysomnography
Measured: 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
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.
Measured: 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.
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.
Measured: 1 to 2 weeks before to immediately after the ultradian sleep/wake protocol.
Performance on the Psychomotor Vigilance Task
This outcome will be measured during the Psychomotor Vigilance Task, specifically lapses (reaction times > 500 ms) on this sustained attention task.
Measured: Collected every 2 hours during the ultradian sleep/wake protocol, up two 36 hours.
Performance on the Reward Anti-Saccade task
This outcome will be measured during the Reward Anti-Saccade task, which measures the ability to look away from a target (an anti-saccade).
Measured: Collected every two hours during the ultradian sleep/wake protocol, up two 36 hours.
Substance use
Frequency-based self-reports of substance use.
Measured: Every 6 months for the duration of the study, up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start4 Mar 2022
- Primary completion31 Mar 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Peter Franzen, University of Pittsburgh
- Investigators
- Peter L. Franzen, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336084
- Sponsor's protocol ID
- STUDY20030237
- Other IDs
- P50DA046346
- Acronym
- CARRS-P1
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Current and future investigators, both internal and external, may have access to de-identified data; however only group data would be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for Adolescent Reward, Rhythms and Sleep Project 1
- ClinicalTrials.gov ID
- NCT05336084
- Acronym / sponsor ID
- CARRS-P1 / STUDY20030237
- Conditions
- Sleep
- Keywords
- adolescence, sleep, substance use, reward sensitivity and motivation, circadian phase and alignment, homeostatic sleep drive, ultradian sleep/wake schedule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultradian Sleep/Wake protocol | Experimental | Behavioral: Ultradian sleep/wake protocolThis 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultradian sleep/wake protocol120-minute schedule, consisting of 80 minutes awake followed by a 40 minute sleep opportunity for up to 36 hours | Behavioural | Ultradian Sleep/Wake protocol |
Primary outcome
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.
8 secondary outcomes
Circadian pattern of Core Body Temperature (CBT)
Time frame: Measured continuously across the ultradian sleep/wake protocol, up two 36 hours.
Melatonin amplitude
Time frame: Collected every 30-60 minutes across the ultradian sleep/wake protocol, up two 36 hours
Sleep latency
Time frame: 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
Time frame: 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.
Time frame: 1 to 2 weeks before to immediately after the ultradian sleep/wake protocol.
Performance on the Psychomotor Vigilance Task
Time frame: Collected every 2 hours during the ultradian sleep/wake protocol, up two 36 hours.
Performance on the Reward Anti-Saccade task
Time frame: Collected every two hours during the ultradian sleep/wake protocol, up two 36 hours.
Substance use
Time frame: Every 6 months for the duration of the study, up to 4.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. Current and future investigators, both internal and external, may have access to de-identified data; however only group data would be shared.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter L. Franzen, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultradian sleep/wake protocol in people with Sleep, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronette Blake, MS ((412) 443-3704, blakerg2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.