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Hormone Therapy

Melatonin for Traumatic Brain Injury

Oregon Health & Science University, Portland, OR
Targeting 3 different conditionsmelatonin +1 morePhase 2RecruitingLed by Cydni Williams, MDResearch Sponsored by Oregon Health and Science University

Study Summary

This trial will test if a melatonin intervention can help reduce sleep wake disturbances for pediatric TBI survivors, which will be measured by questionnaires and activity monitors.

Eligible Conditions
  • Traumatic Brain Injury
  • Critical Illness
  • Sleep

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recruitment
Retention
sleep disturbance
Secondary outcome measures
Chronotype
Fatigue
adherence qualitative
+11 more
Other outcome measures
anxiety
cognitive functioning
depression
+4 more

Side effects data

From 2017 Phase 3 trial • 709 Patients • NCT00668707
16%
Fatgiue
11%
Insomnia
10%
Death
9%
Nausea
9%
Dyspnea
8%
Diarrhea
5%
Postoperative Pain
4%
Cough
4%
Constipation
3%
Headache
3%
Peripheral Neuropathy
3%
Neutropenia
3%
Vomiting
2%
Air Leak
2%
Dizziness
2%
Appetite changes
2%
Chest pain
2%
Cold/Flu Symptoms
1%
Tinnitus
1%
GERD
1%
Pneumonia
1%
Epistaxis
1%
Pneumothorax
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Bonchitis
1%
Syncope
1%
Vertigo
1%
Anorexia
1%
Anxiety
1%
Depression
1%
Hip replacement surgery
1%
Pulmonary embolism
1%
Subcutaneous Emphysema
1%
Anemia
1%
Atrial fibrillation
1%
Acid reflux
1%
Flatulence
1%
Indigestion
1%
Peripheral Edema
1%
Weight loss
1%
Gall bladder attack
1%
C-Difficile
1%
Surgical site infection
1%
Back pain
1%
Fall
1%
Pain
1%
Radiation pneumonitis
1%
Surgical Site Pain
1%
Dry Cough
1%
Pleural effusion
1%
New Neoplasm
1%
New Neoplasm - Lung Cancer
1%
Hypertension
1%
Tachycardia
1%
Dysphagia
1%
Sinus infection
1%
Myalgia
1%
Hearing loss
1%
Hemoptysis
1%
dry mouth
1%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2013
Completed Phase 3
~2260

Find a site

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
931 Previous Clinical Trials
6,829,989 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,713 Previous Clinical Trials
47,168,839 Total Patients Enrolled
Cydni Williams, MDPrincipal Investigator
Oregon Health and Science University

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04932096 — Phase 2
Traumatic Brain Injury Research Study Groups: Melatonin, Placebo
Traumatic Brain Injury Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT04932096 — Phase 2
Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932096 — Phase 2

Frequently Asked Questions

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

Am I qualified to participate in this scientific experiment?

"This medical trial requires its participants to be suffering from a severe illness and aged between 6 and 18. The total capacity of this experiment is 110 individuals."

Answered by AI

Can individuals expect any unwanted side effects from a sleep management regimen?

"The risk associated with the sleep management plan is estimated to be a 2 according to our team at Power. This Phase 2 trial has some evidence in favour of safety, but no data demonstrating efficacy yet."

Answered by AI

Is there room for more participants in this experiment?

"According to clinicaltrials.gov, this research project is not taking on any new patients at present; the study was initially posted on September 1st 2022 and recently updated on August 11th 2022. Despite this, there are 1198 other studies currently recruiting participants."

Answered by AI

What objectives is this scientific experiment seeking to accomplish?

"During this 6-month medical trial, the principal objective is to evaluate retention. Other desirable outcomes encompass assessment of adverse events both at baseline and follow-up, as well as fatigue scores obtained via a parent proxy report using the PedsQL Multidimensional Fatigue Scale with 0 representing no function and 100 indicating optimal functioning."

Answered by AI

Does this experiment accept elderly participants?

"The age criteria for this clinical trial necessitates that participants are between 6 and 18 years old. There is an abundance of trials devoted to children, with 204 studies targeting those below the age of 18, as well as a plethora of 929 research initiatives for seniors above 65."

Answered by AI
Recent research and studies
Pediatric NeurologyJournal
Sleep-wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care
Williams, Cydni N., Mary E. Hartman, Cindy T. McEvoy, Trevor A. Hall, Miranda M. Lim, Steven A. Shea, Madison Luther, et al.. 2020. “Sleep-wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care”. Pediatric Neurology. Elsevier BV. doi:10.1016/j.pediatrneurol.2019.08.010.
SleepJournal
Sleep Disturbances After Pediatric Traumatic Brain Injury: A Systematic Review of Prevalence, Risk Factors, and Association with Recovery
Luther, Madison, Katrina M Poppert Cordts, and Cydni N Williams. 2020. “Sleep Disturbances After Pediatric Traumatic Brain Injury: A Systematic Review of Prevalence, Risk Factors, and Association with Recovery”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/zsaa083.
Neurocritical CareJournal
Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population
Poppert Cordts, Katrina M., Trevor A. Hall, Mary E. Hartman, Madison Luther, Amanda Wagner, Juan Piantino, Kristin P. Guilliams, Rejean M. Guerriero, Jalane Jara, and Cydni N. Williams. 2019. “Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population”. Neurocritical Care. Springer Science and Business Media LLC. doi:10.1007/s12028-019-00883-5.
clinicaltrials.govStudy
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Cydni Williams 2023. "Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04932096.
~73 spots leftby Jul 2025
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