Ultradian sleep/wake protocol for Sleep

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Western Psychiatric Hospital, Pittsburgh, PA
Sleep
Ultradian sleep/wake protocol - Behavioral
Eligibility
< 18
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Every 6 months for the duration of the study, up to 4.5 years

Week 2
Influence of sleep and circadian measures on neural correlates of reward anticipation and reward outcome.
Performance on the Psychomotor Vigilance Task
Collected every 30-60 minutes across the first 24-hours of the ultradian sleep/wake protocol
Melatonin amplitude
During the 40-minute sleep opportunities collected every two hours across the 36-hour ultradian sleep/wake protocol.
Sleep latency
Hour 2
Change in slope of waking EEG theta power
Year 5
Substance use
Measured continuously across the 36-hour ultradian sleep/wake protocol.
Circadian pattern of Core Body Temperature (CBT)
Measures collected every two hours during the 36-hour ultradian sleep/wake protocol.
Performance on the Reward Anti-Saccade task
Week 2
Influence of sleep and circadian measures on neural correlates of impulse control
The first 24-hours of the ultradian sleep/wake protocol
Melatonin onset
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 EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.

Trial Safety

Trial Design

1 Treatment Group

Ultradian Sleep/Wake protocol
1 of 1
Experimental Treatment

96 Total Participants · 1 Treatment Group

Primary Treatment: Ultradian sleep/wake protocol · No Placebo Group · N/A

Ultradian Sleep/Wake protocol
Behavioral
Experimental Group · 1 Intervention: Ultradian sleep/wake protocol · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 6 months for the duration of the study, up to 4.5 years
Closest Location: Western Psychiatric Hospital · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Sleep
0 CompletedClinical Trials

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,486 Total Patients Enrolled
10 Trials studying Sleep
2,950 Patients Enrolled for Sleep
National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,383 Total Patients Enrolled
Peter L. Franzen, PhDPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

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You are currently enrolled in a traditional high-school.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.