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Ultradian Sleep/Wake Protocol for Sleep Patterns (CARRS-P1 Trial)

N/A
Recruiting
Led By Peter L. Franzen, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 13-15 years
Be younger than 18 years old
Must not have
History of sleep disorders other than insomnia or Delayed Sleep Phase Disorder
Outside age range of 13-15 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months for the duration of the study, up to 4.5 years
Awards & highlights

Summary

This trial is examining how sleep patterns, reward, and cognition are linked, and how this may impact a person's risk for substance abuse.

Who is the study for?
This trial is for healthy teenagers aged 13-15 who attend a traditional high school and are not home-schooled. They must not have sleep apnea, be within a certain weight range, and cannot have serious medical conditions or a history of substance use. Those on certain medications or with MRI contraindications like metal implants can't participate.
What is being tested?
The study investigates how disrupted sleep patterns and circadian rhythms affect reward systems and cognitive control in adolescents, potentially influencing substance use risk. It involves an ultradian sleep/wake protocol to assess these effects at subjective, behavioral, and neural circuit levels.
What are the potential side effects?
Since this trial focuses on monitoring natural processes like sleep rather than testing drugs, there may be minimal side effects related to the intervention itself such as discomfort from the experimental setting or fatigue due to altered sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 15 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a sleep disorder that is not insomnia or Delayed Sleep Phase Disorder.
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I am not between the ages of 13 and 15.
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I have a close family member with bipolar disorder.
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I have a history of serious medical or neurological disorders, including seizures.
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I weigh less than 80 lbs or my BMI is over 35.
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I cannot swallow pills or capsules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months for the duration of the study, up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months for the duration of the study, up to 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.
Change in slope of waking EEG theta power
Melatonin onset
Secondary study objectives
Circadian pattern of Core Body Temperature (CBT)
Influence of sleep and circadian measures on neural correlates of impulse control
Influence of sleep and circadian measures on neural correlates of reward anticipation and reward outcome.
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ultradian Sleep/Wake protocolExperimental Treatment1 Intervention
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) for 36 hours. The ultradian sleep/wake protocol will last for 36 h, during which every 120-minutes, there will be an 80-minute period of waking, followed by a 40-minute sleep opportunity. A repeat night of sleep will occur at the end of the 36-hour ultradian sleep/wake protocol.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,280 Total Patients Enrolled
University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,907 Total Patients Enrolled
14 Trials studying Sleep
1,990 Patients Enrolled for Sleep
Peter L. Franzen, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Ultradian sleep/wake protocol Clinical Trial Eligibility Overview. Trial Name: NCT05336084 — N/A
Sleep Research Study Groups: Ultradian Sleep/Wake protocol
Sleep Clinical Trial 2023: Ultradian sleep/wake protocol Highlights & Side Effects. Trial Name: NCT05336084 — N/A
Ultradian sleep/wake protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336084 — N/A
~16 spots leftby Mar 2025
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