Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents (CARRS-P1)

University of Pittsburgh

Status: Enrolling

Conditions: Sleep

Treatments: Behavioral: Ultradian sleep/wake protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05336084

P50DA046346 (U.S. NIH Grant/Contract)

STUDY20030237

Details and patient eligibility

About

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.

Full description

P1 will study 96 adolescents ages 13-15, stratified by habitual sleep timing (early, intermediate, late), in a 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 60-hour laboratory visit. The laboratory session includes two nights of polysomnography (PSG) sleep studies, separated by 36 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. Participants will be in dim light conditions and temporal isolation for the first 24 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 36-h ultradian sleep/wake protocol, 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 13 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 13-15 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

Exclusion criteria

• outside age range above
• have a history of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly 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
• 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 design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

96 participants in 1 patient group

Ultradian Sleep/Wake protocol

Experimental group

Description:

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.

Treatment:

Behavioral: Ultradian sleep/wake protocol