Trial · NCT04932096

Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

NCT04932096, Phase 2, Completed, Oregon Health and Science University; results first posted 2025-08-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin. Trials, record NCT04932096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04932096

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
NCT number: NCT04932096
Status: Completed
Phases: Phase 2
Enrollment: 21 participants, actual
Lead sponsor: Oregon Health and Science University
Conditions: Traumatic Brain Injury, Critical Illness, Sleep
Interventions: melatonin, placebo
First posted: 2021-06-18
Last updated: 2025-08-20
Results first posted: 2025-08-20
Limitations and caveats: Pilot trial with small number of participants recruited. Results focus on feasibility, was not powered to detect differences in sleep and other secondary outcomes.

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Sleep Disturbances Scale for Children	1-month	Sleep Disturbances Scale for Children (SDSC): 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measure defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating worse dysfunction, and T-scores greater than 60 generally indicating clinically significant dysfunction in the total score and all 6 subscale scores. The subscales include Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis.
Primary	Recruitment	through study completion, an average of 6-months	Quantitative number of patients consented per patients approached
Primary	Retention	through study completion, an average of 30 days	Quantitative number of participants completing trial procedures per patients consented
Secondary	Adherence Quantitative	1-month	pill counts, report of using study medication at least 5/7 days per week
Secondary	Adherence Qualitative	1-month	participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention
Secondary	Pediatric Quality of Life Inventory Multidimensional Fatigue Scale	1-month	Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS); 18 item parent proxy report of fatigue using a likert scale. Responses to each question receive a score of 0, 25,50,75, or 100. The measure provides a total score and three subscale scores- General, Sleep/rest, and Cognitive fatigue subscales based on the average response to each question for the total score and the average response to each subscale's questions for the subscale scores. All scores (total and subscale) range 0-100 with higher scores indicating better function and less fatigue.
Secondary	Chronotype	1-month	Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness)
Secondary	Sleep Latency	1-month	actigraphy measured time in minutes to fall asleep
Secondary	Total Sleep Time	1-month	actigraphy measured total time asleep in minutes
Secondary	Wake After Sleep Onset	1-month	actigraphy measured time in minutes awake after sleep onset

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Sleep Disturbances Scale for Children	1-month		T-score	MEDIAN
PRIMARY	Recruitment	through study completion, an average of 6-months	Number of eligible patients approached for consent	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Retention	through study completion, an average of 30 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adherence Quantitative	1-month		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adherence Qualitative	1-month		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pediatric Quality of Life Inventory Multidimensional Fatigue Scale	1-month		score on a scale	MEDIAN
SECONDARY	Chronotype	1-month		score on a scale	MEDIAN
SECONDARY	Sleep Latency	1-month	Actigraphy usable providing 5/7 days per week of data	minutes	MEDIAN
SECONDARY	Total Sleep Time	1-month	Actigraphy usable data if 5/7 days per week	minutes	MEDIAN
SECONDARY	Wake After Sleep Onset	1-month		minutes	MEDIAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group82

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Sleep Disturbances Scale for Children	Melatonin	Total T-score	55	Inter-Quartile Range 47 to 68	T-score
Sleep Disturbances Scale for Children	Placebo	Total T-score	69	Inter-Quartile Range 63 to 79	T-score
Sleep Disturbances Scale for Children	Melatonin	Initiation and Maintenance T-score	64	Inter-Quartile Range 50 to 89	T-score
Sleep Disturbances Scale for Children	Placebo	Initiation and Maintenance T-score	73	Inter-Quartile Range 64 to 79	T-score
Sleep Disturbances Scale for Children	Melatonin	Breathing T-score	51	Inter-Quartile Range 45 to 51	T-score
Sleep Disturbances Scale for Children	Placebo	Breathing T-score	58	Inter-Quartile Range 51 to 58	T-score
Sleep Disturbances Scale for Children	Melatonin	Arousal T-score	47	Inter-Quartile Range 47 to 47	T-score
Sleep Disturbances Scale for Children	Placebo	Arousal T-score	58	Inter-Quartile Range 47 to 58	T-score
Sleep Disturbances Scale for Children	Melatonin	Transition T-score	50	Inter-Quartile Range 50 to 54	T-score
Sleep Disturbances Scale for Children	Placebo	Transition T-score	54	Inter-Quartile Range 50 to 79	T-score

1 to 10 of 82Source ClinicalTrials.gov

See all 82 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin	10
Overall Study	STARTED	Placebo	11
Overall Study	COMPLETED	Melatonin	9
Overall Study	COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	Melatonin	1
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	Melatonin	0	10	0
other	Fatigue	General disorders	Placebo	1	11	1
other	Headaches	Nervous system disorders	Melatonin	2	10	2
other	Headaches	Nervous system disorders	Placebo	2	11	2
other	Behavior change with increased anxiety	General disorders	Melatonin	0	10	0
other	Behavior change with increased anxiety	General disorders	Placebo	2	11	2
other	double vision	Eye disorders	Melatonin	1	10	1
other	double vision	Eye disorders	Placebo	0	11	0
other	motion sickness	Ear and labyrinth disorders	Melatonin	1	10	1
other	motion sickness	Ear and labyrinth disorders	Placebo	0	11	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin	0	10
Total, all-cause mortality	Placebo	0	11
Total, other adverse events	Melatonin	4	10
Total, other adverse events	Placebo	2	11
Total, serious adverse events	Melatonin	1	10
Total, serious adverse events	Placebo	0	11

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31735567	BACKGROUND	PubMed
31797275	BACKGROUND	PubMed
32328648	BACKGROUND	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23HL150229	Sleep Management And Recovery after Traumatic Brain Injury in Kids (SMART-Kids): Evidence for targeting sleep to improve outcomes	WILLIAMS, CYDNI NICOLE	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2020 to 2024

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Melatonin vs Placebo: Adherence Quantitative	Trial comparisons
Melatonin vs Placebo: Adherence Qualitative	Trial comparisons
Melatonin vs Placebo: deaths from any cause	Trial comparisons
Melatonin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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