Melatonin Adolescent Research Study (MARS)

Loma Linda University (LLU)

Status: Enrolling

Conditions: Sleep Disorders in Children

Treatments: Other: Placebo; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04588233

5200334

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Administration of Melatonin

Experimental group

Treatment:

Dietary Supplement: Melatonin

Administration of Placebo

Placebo Comparator group

Treatment:

Other: Placebo