Actively Recruiting
Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
Led by Loma Linda University · Updated on 2026-01-30
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of melatonin supplementation on sleep and daytime functioning in adolescents aged 13 to 17 who have short or disrupted sleep due to behavioral causes, such as difficulty falling asleep, staying asleep, or waking too early. This study uses a randomized, double-blind, crossover design to compare melatonin with a placebo. The goal is to understand how melatonin influences sleep duration and emotional regulation in typically developing adolescents without organic sleep disorders. Participants will receive 3 mg of melatonin or a placebo one hour before bedtime for 12 consecutive nights during each treatment period. The study uses a crossover method, meaning each adolescent will experience both melatonin and placebo treatments at different times, allowing direct comparison within the same individual. This design helps researchers assess the impact of melatonin more accurately by controlling for individual differences. During the study, participants will be monitored for changes in objective sleep duration and emotional regulation using specific tools over two-week periods for each treatment. Researchers will collect data on sleep patterns and daytime functioning to determine the effects of melatonin versus placebo. Participants will be followed through these treatment periods to measure changes and ensure safety, contributing valuable information on melatonin's impact on adolescent sleep and daily performance.
CONDITIONS
Brief Title
Melatonin Adolescent Research Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identified sleep difficulties such as trouble falling asleep, staying asleep, or waking early resulting in short or disrupted sleep
- Ages 13 to 17 years old
- Able to understand, read, and write in English
- Never taken melatonin before
You will not qualify if you...
- Obesity
- Use of psychiatric medication
- Use of drugs or supplements known to affect sleep
- History of head injury or concussion with loss of consciousness lasting more than 1 minute
- Daily consumption of more than one caffeinated beverage
- Risk for any organic sleep disorder such as obstructive sleep apnea or restless leg syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 nights per treatment period
Participants receive either 3mg of melatonin or a placebo 1 hour prior to bedtime for 12 consecutive nights in a crossover design.
2 treatment periods each lasting 12 nights
Trial Site Locations
Total: 2 locations
1
Loma Linda University
Loma Linda, California, United States, 92350
Not Yet Recruiting
2
Loma Linda U
Loma Linda, California, United States, 92354
Actively Recruiting
Research Team
B
Brooke Iwamoto
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here