Melatonin Adolescent Research Study

Conditions

• Sleep Disorders in Children

Eligibility Criteria

Sex

ALL

Age

13 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Melatonin — DIETARY_SUPPLEMENT
  Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
• Placebo — OTHER
  Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Study Details

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).

Key Dates

Start date

Sep 15, 2021

Status verified

Jan 2026

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Administration of Melatonin
• Placebo Comparator: Administration of Placebo

Primary Outcome Measure

Change in Objective Sleep Duration During Melatonin Administration [ Time Frame: Change between baseline and two weeks ]

Central Contacts

• Brooke Iwamoto
  909-558-7412
  [email protected]

Locations (2)

Find similar trials in Loma Linda, CA