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Melatonin for Adolescent Sleep Difficulties Study

This study is testing whether melatonin helps teenagers with sleep difficulties. We're looking for adolescents aged 13-17 who have trouble falling asleep, staying asleep, or waking too early, and who haven't used melatonin before. You'll receive either 3mg of melatonin or a placebo (an inactive pill) for 12 nights, and then switch to the other for another 12 nights. We'll measure how long you sleep to see if melatonin improves sleep duration. The study's current status is unclear, so we don't know if they are actively enrolling.

Study design
This is an interventional study with a randomized, crossover design, meaning you will receive both melatonin and placebo at different times. It plans to enroll 80 participants.
What's involved
You will take either melatonin or a placebo for 12 consecutive nights, then switch to the other for another 12 nights.
Compensation
Not stated in the trial record.
Follow-up
Your sleep duration will be measured at the change between baseline and two weeks after starting each treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04588233

Melatonin Adolescent Research Study

Recruiting
NAAges 13–17InterventionalTreatment
Loma Linda University
~80 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:MelatoninPlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Objective Sleep Duration During Melatonin Administration
Measured over Change between baseline and two weeks
+1 more outcome measured

Conditions

Sleep Disorders in Children

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Sleep Disorder

Where it's being run

2 sites across 1 states
California2

Study leadership

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

Who to contact

Brooke Iwamoto
[email protected]
909-558-7412
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
Ages 13 to 17 years old
Able to understand, read, and write in English
Melatonin naive

Exclusion

Obesity
Use of psychiatric medication
Drug(s), or supplements known to affect sleep
History of head injury or concussion with loss of consciousness \>1 minute
Daily consumption of \>1 caffeinated beverage
Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)

What this trial measures

  • Change in Objective Sleep Duration During Melatonin AdministrationChange between baseline and two weeks

    Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving melatonin (14 nights/2 weeks total). Changes in objective sleep duration would be demonstrated by either an increase or decrease in number of hours asleep compared to baseline

  • Change in Objective Sleep Duration During Placebo AdministrationChange between baseline and two weeks

    Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving placebo (14 nights/2 weeks total). No change in objective sleep duration would be demonstrated compared to baseline