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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months for the duration of the study, up to 4.5 years

Awards & highlights

CARRS-P1 Trial 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.Check my eligibility

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.See study design

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.

CARRS-P1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 13 and 15 years old.

CARRS-P1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months for the duration of the study, up to 4.5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

CARRS-P1 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,634 Total Patients Enrolled

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,850 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to adults aged 20 and above?

"This research requires participants to have ages ranging from 13 to 15 years old. 32 trials are open for enrolment of those younger than 18, and 87 studies accept senior citizens over 65 as eligible volunteers."

Answered by AI

Does the protocol of this trial allow me to participate?

"Candidates between the ages of 13 and 15 who are struggling with sleep disturbances can apply to this clinical trial. Approximately 96 individuals will be selected for participation."

Answered by AI

What is the scope of participants for this trial?

"Affirmative. Information found on clinicaltrials.gov illustrates that this research trial is actively seeking new candidates, which began being posted on March 4th 2022 and recently updated on April 14th 2022. Specifically, the study requires 96 people to be recruited from 1 site."

Answered by AI

What aims are paramount in this trial's agenda?

"This trial's primary objective is to evaluate the alteration in waking EEG theta power during a 36-hour ultradian sleep/wake protocol. Secondary objectives involve scrutinizing neural activity associated with impulse control, measured by a fMRI Stop Signal Task; assessing performance of the Psychomotor Vigilance Test through observing lapses in sustained attention and measuring amplitude of 24-hour melatonin period for an estimation of endogenous circadian phase."

Answered by AI

Is recruitment still active for this study?

"According to available data on clinicaltrials.gov, this clinical trial is presently seeking participants; the listing was initially posted in March 2022 and recently edited in April of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Peter Franzen 2022. "Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336084.

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