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NCT04588233 · ClinicalTrials.gov registry record · NA
Melatonin Adolescent Research Study
A NA study of Sleep Disorders in Children, sponsored by Loma Linda University.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT04588233: Recruiting NA study of Sleep Disorders in Children, sponsored by Loma Linda University.
NCT04588233 is a NA study of Sleep Disorders in Children that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04588233, a NA study of Sleep Disorders in Children, is actively recruiting participants, sponsored by Loma Linda University.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Melatonin
Study Locations (2)
California
- Loma Linda University - Loma Linda
- Loma Linda U - Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT04588233 shows while recruiting
NCT04588233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Sleep Disorders in Children appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04588233 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04588233 about?
NCT04588233 is a clinical study titled "Melatonin Adolescent Research Study". 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 asle...
What is the current status of trial NCT04588233?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-09-15. Estimated completion is 2026-05.
What conditions does trial NCT04588233 study?
This clinical trial studies the following conditions: Sleep Disorders in Children.
What interventions are being tested in trial NCT04588233?
The interventions under investigation include: Placebo (OTHER), Melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04588233?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04588233 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04588233's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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