RECRUITING

Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens

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. Many studies find that this increases 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 2 (P2) of the CARRS center will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.

Official Title

Center for Adolescent Reward, Rhythms and Sleep Project 2

Quick Facts

Study Start:2021-05-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04792697

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. * Typically enrolled in a traditional high-school with synchronous learning (in-person or online synchronous learning, but not cyber- or home-schooling) \[school closures during the COVID-19 pandemic are an exception to this\]
  2. * Physically and psychiatrically healthy
  3. * Provision of written informed consent and assent
  4. * Additional inclusion criterion for Experimental protocol: Meets operational definition of late sleep timing (\>11:15PM habitual bedtime)
  1. * History of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year
  2. * Significant or unstable acute or chronic medical conditions
  3. * Frequent headaches or migraines
  4. * History of seizures
  5. * Current serious psychiatric disorder (e.g., depressive disorder, bipolar disorder, eating disorder, psychotic disorder diagnosis, alcohol use disorder or substance use disorder) that would interfere with completion of study procedures
  6. * Family history of bipolar disorder among first degree relative
  7. * Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
  8. * MRI contraindications (ie, absence of metal in the body, pregnancy, claustrophobia)
  9. * Pregnancy
  10. * Medications that increase sensitivity to blue light/photosensitizing medications, including psychiatric neuroleptic drugs, psoralen drugs, antiarrhythmic drugs, etc.
  11. * Changes to psychotropic medication regimen in the 2 weeks prior to enrollment, and/or major changes to medications during the study protocol
  12. * If participants have an average bedtime that is later than 3:00AM or an average wake time later than 11:00AM they cannot participate in the study
  13. * Participants should be EXCLUDED for other sleep disorders that require ongoing treatment
  14. * Participants should be EXCLUDED for other sleep disorders that cause significant distress or impairment, per DSM 5 criteria in the Sleep SCID.

Contacts and Locations

Study Contact

Ronette G Blake, MS
CONTACT
(412) 246-6443
blakerg2@upmc.edu

Principal Investigator

Brant Hasler, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Brant Hasler, 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 Date2021-05-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-05-01
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
  • inhibition

Additional Relevant MeSH Terms

  • Delayed Sleep Phase Syndrome