RECRUITING

Melatonin Adolescent Research Study

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

The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).

Official Title

Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)

Quick Facts

Study Start:2021-09-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04588233

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 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
  2. * Ages 13 to 17 years old
  3. * Able to understand, read, and write in English
  4. * Melatonin naive
  1. * Obesity
  2. * Use of psychiatric medication
  3. * Drug(s), or supplements known to affect sleep
  4. * History of head injury or concussion with loss of consciousness \>1 minute
  5. * Daily consumption of \>1 caffeinated beverage
  6. * Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)

Contacts and Locations

Study Contact

Brooke Iwamoto
CONTACT
909-558-7412
biwamoto@llu.edu

Principal Investigator

Tori Van Dyk, PhD
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92350
United States
Loma Linda U
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Tori Van Dyk, PhD, PRINCIPAL_INVESTIGATOR, Loma Linda University

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 Date2021-09-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-09-15
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Melatonin
  • Sleep Disturbance
  • Adolescents
  • Daytime Functioning

Additional Relevant MeSH Terms

  • Sleep Disorders in Children