RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Center for Adolescent Reward, Rhythms and Sleep Project 1

Quick Facts

Study Start:2022-03-04
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05336084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age 13-15 years
  2. * Currently enrolled in a traditional high-school (not cyber- or home-schooled) \[school closures during the COVID-19 pandemic are an exception to this\]
  3. * Physically and psychiatrically healthy
  4. * Provision of written informed consent and assent
  1. * outside age range above
  2. * have a history of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year
  3. * have serious medical or neurological disorders, including history of seizures
  4. * have serious psychiatric disorders (e.g. bipolar disorder and schizophrenia)
  5. * 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
  6. * have sleep disorders other than insomnia or Delayed Sleep Phase Disorder
  7. * have MRI contraindications (i.e., metal in the body; claustrophobia)
  8. * first degree relative with bipolar disorder
  9. * frequent headaches or migraines
  10. * inability to swallow pills/capsules.
  11. * pregnancy
  12. * participants with observed Obstructive Sleep Apnea via Apnealink, as indicated by an Apnea Hypopnea Index (AHI) of greater than 5
  13. * Less than 80 lbs. or a BMI of greater than 35

Contacts and Locations

Study Contact

Ronette Blake, MS
CONTACT
(412) 443-3704
blakerg2@upmc.edu
Sarah Aerni
CONTACT
412-551-110
aernise2@upmc.edu

Principal Investigator

Peter L. Franzen, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Peter L. Franzen, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-04
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-03-04
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • adolescence
  • sleep
  • substance use
  • reward sensitivity and motivation
  • circadian phase and alignment
  • homeostatic sleep drive
  • ultradian sleep/wake schedule

Additional Relevant MeSH Terms

  • Sleep