Effects of melatonin on sleep in adolescents
Official title: Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
Run by Loma Linda University · NCT04588233 · Data updated 2026-11-12
This study is testing if giving melatonin to teenagers aged 13 to 17 who have trouble sleeping can help them sleep better and feel more alert during the day.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 13 Years to 17 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Loma Linda University Academic / other |
| Locations | 2 sites (Loma Linda, California and 1 other locations) |
| Status | Recruiting |
| Started | September 15, 2021 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT04588233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adolescents aged 13 to 17 who self-identify as having sleep difficulties but do not have any underlying organic sleep disorders.
✕Probably not a fit
Patients with obesity, those on psychiatric medications, or individuals with a history of head injury may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of melatonin supplementation on sleep and daytime functioning in adolescents aged 13 to 17 who experience sleep difficulties due to behavioral issues. Utilizing a within-person, randomized cross-over design, participants will alternate between receiving melatonin and a placebo to assess changes in their sleep patterns and daytime alertness. The focus is on typically developing adolescents who are melatonin naive and do not have underlying organic sleep disorders. The study aims to provide insights into how melatonin can improve sleep quality and overall functioning in this age group.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for improving sleep quality and daytime functioning in adolescents with sleep disturbances.
How similar studies have gone: Other studies have shown promising results with melatonin supplementation for sleep disorders, indicating that this approach is supported by existing research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where it's running
-
Loma Linda U
Loma Linda, California, United States Recruiting -
Loma Linda University
Loma Linda, California, United States Not yet recruiting
Study contacts
- Principal investigator: Tori Van Dyk, PhD — Loma Linda University
- Study coordinator: Brooke Iwamoto
- Email: biwamoto@llu.edu
- Phone: 909-558-7412
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.