Melatonin Adolescent Research Study
Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
Loma Linda University
80 participants
Sep 15, 2021
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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)
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Interventions
Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04588233