Other

Melatonin for Childhood Sleep Disorders

Q: Is this trial open to individuals aged 85 and above?

<p>The age <a href="https://www.withpower.com/clinical-trials/ra">ra</a>nge for eligibility in this clinical trial is 13 to 17 years old, as specified by the inclusion criteria.</p>

Loma Linda University, Loma Linda, CA

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Melatonin naive

Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep)

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upchange between baseline and two weeks

Awards & highlights

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and two weeks

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%

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

0 / 2Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Melatonin Adolescent Research Study

2021. "Melatonin Adolescent Research Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04588233.

~27 spots leftby Sep 2024

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