Recruiting

Melatonin

Sponsor:

Loma Linda University

Code:

NCT04588233

Conditions

Sleep Disorders in Children

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Melatonin

Placebo

Study Details

Brief 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).

Conditions

Sleep Disorders in Children

Study ID

NCT04588233

Start date

Sep 15, 2021

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of Melatonin

placebo comparator: Administration of Placebo

Interventions

Melatonin

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

Placebo

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Brooke Iwamoto

909-558-7412biwamoto@llu.edu

Locations

Loma Linda U

Recruiting

Loma Linda, California, United States, 92354

More Information

Sponsor

Loma Linda University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Melatonin
  • Sleep Disturbance
  • Adolescents
  • Daytime Functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-07-10.