Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05336084

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

Center for Adolescent Reward, Rhythms and Sleep Project 1

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
13 Years – 18 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALUltradian sleep/wake protocol120-minute schedule, consisting of 80 minutes awake followed by a 40 minute sleep opportunity for up to 36 hours

Timeline

Start date
2022-03-04
Primary completion
2030-03-31
Completion
2030-05-31
First posted
2022-04-20
Last updated
2026-04-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05336084. Inclusion in this directory is not an endorsement.