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Melatonin for Childhood Sleep Disorders

Loma Linda University, Loma Linda, CA
Melatonin +1 moreN/ARecruitingLed by Tori Van Dyk, PhDResearch Sponsored by Loma Linda University

Study Summary

This trial will test whether melatonin can help improve the sleep of adolescents with behavioral sleep disruptions.

Eligible Conditions
  • Childhood Sleep Disorders

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have not taken melatonin before.
Select...
You have trouble falling asleep, staying asleep, or waking up earlier than you want to.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Objective Sleep Duration During Melatonin Administration
Change in Objective Sleep Duration During Placebo Administration
Secondary outcome measures
Melatonin
Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Dizziness
11%
Nausea
11%
Weakness
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Administration of MelatoninExperimental Treatment1 Intervention
Group II: Administration of PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a site

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
293 Previous Clinical Trials
258,069 Total Patients Enrolled
Tori Van Dyk, PhDPrincipal Investigator
Loma Linda University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still enrolling participants?

"The clinicaltrials.gov resource confirms that this trial is still searching for participants, with the initial post date having been on September 15th 2021 and the most recent update being logged on September 19th 2022."

Answered by AI

Could I be accepted into this research program?

"This investigation is inviting 80 youths between the ages of 13 and 17 with sleep disturbances to participate. Aspiring candidates must evidence self-reported sleeping issues, be able to comprehend English, not have taken melatonin beforehand, and meet all other requirements as detailed in the protocol."

Answered by AI

How many participants are taking part in this experiment?

"Affirmative. The requirements for this medical trial, which was introduced on September 15th 2021, are currently being sought after by the research team. They need 80 volunteers from 2 different sites to complete their study."

Answered by AI

Is this trial open to individuals aged 85 and above?

"The age range for eligibility in this clinical trial is 13 to 17 years old, as specified by the inclusion criteria."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Loma Linda U
What portion of applicants met pre-screening criteria?
Did not meet criteria
~27 spots leftby Sep 2024