Melatonin Adolescent Research Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Placebo.
- Who it may be relevant to
- Registry conditions: Sleep Disorders in Children. Basic parameters: 13 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
Overview
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).
Interventions
- Dietary supplement Melatonin
Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights - Other Placebo
Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
Primary outcome measures
- Change in Objective Sleep Duration During Melatonin Administration [Time frame: Change between baseline and two weeks]
- Change in Objective Sleep Duration During Placebo Administration [Time frame: Change between baseline and two weeks]
Secondary outcome measures (2)
- Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA) [Time frame: Change between baseline and two weeks]
- Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA) [Time frame: Change between baseline and two weeks]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Loma Linda University — Loma Linda
- Loma Linda U — Loma Linda
Identifiers
NCT: NCT04588233 · 5200334