NCT04588233

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

October 7, 2020

Last Update Submit

January 28, 2026

Conditions

Sleep Disorders in Children

Keywords

MelatoninSleep DisturbanceAdolescentsDaytime Functioning

Outcome Measures

Primary Outcomes (2)

  • Change in Objective Sleep Duration During Melatonin Administration

    Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving melatonin (14 nights/2 weeks total). Changes in objective sleep duration would be demonstrated by either an increase or decrease in number of hours asleep compared to baseline

    Change between baseline and two weeks

  • Change in Objective Sleep Duration During Placebo Administration

    Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving placebo (14 nights/2 weeks total). No change in objective sleep duration would be demonstrated compared to baseline

    Change between baseline and two weeks

Secondary Outcomes (2)

  • Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)

    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)

    Change between baseline and two weeks

Study Arms (2)

Administration of Melatonin

EXPERIMENTAL
Dietary Supplement: Melatonin

Administration of Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

MelatoninDIETARY_SUPPLEMENT

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

Administration of Melatonin
PlaceboOTHER

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

Administration of Placebo

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loma Linda University

Loma Linda, California, 92350, United States

NOT YET RECRUITING

Loma Linda U

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Tori Van Dyk, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Iwamoto

CONTACT

909-558-7412biwamoto@llu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 19, 2020

Study Start

September 15, 2021

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)