Melatonin Adolescent Research Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2026-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Sleep Disorders in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Administration of Melatonin

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights

Administration of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Interventions

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Melatonin

Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights

Intervention Type DIETARY_SUPPLEMENT

Placebo

Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No