RECRUITING

The Impact of Melatonin Lotion on Sleep and Mental Health

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 purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.

Official Title

The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects

Quick Facts

Study Start:2025-02-28
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06768749

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:18 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and
  2. * a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)
  1. * currently using antidepressant, anti-anxiety, or sleep medication including melatonin
  2. * are pregnant
  3. * have allergies/sensitivities to scented lotion
  4. * are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.

Contacts and Locations

Study Contact

Lisa E Olson, Ph.D.
CONTACT
909-748-8524
lisa_olson@redlands.edu
Steven Moore, Ph.D.
CONTACT
(909) 748-8687
steven_moore@redlands.edu

Principal Investigator

Lisa E Olson, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Redlands

Study Locations (Sites)

University of Redlands
Redlands, California, 92374
United States

Collaborators and Investigators

Sponsor: University of Redlands

  • Lisa E Olson, Ph.D., PRINCIPAL_INVESTIGATOR, University of Redlands

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 Date2025-02-28
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

  • melatonin
  • sleep
  • heart rate variability
  • actigraphy
  • amylase
  • mood
  • anxiety
  • depression

Additional Relevant MeSH Terms

  • Sleep Problems
  • Depressive Disorder and Anxiety Disorders