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Completed

NCT Number: NCT04932096

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

Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge.

Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Critical Illness Disease Attributes Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Trauma, Nervous System Wounds and Injuries

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Children age ≥6 years and <19 years
  • Traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the Glasgow Coma Scale with the presence of intracranial injury on imaging
  • Admission to Oregon Health & Science University Hospitals
  • Deemed likely to survive hospitalization by clinical care team
  • Able to tolerate enteral medications within 72 hours of admission
  • Child participant resides with parent or legal guardian

Exclusion:

  • Lack stable means of communication with study team (phone, email, mailing address)
  • Abusive trauma suspected or confirmed
  • Dialysis
  • Extracorporeal support (e.g. ECMO)
  • Significant liver injury defined as >2x normal levels for AST or ALT
  • Clinical team safety concerns with use of intervention
  • Pregnancy
  • Prisoners

Treatment and study plan

Melatonin

Drug

melatonin supplementation

Placebo

Other

microcrystalline cellulose filled capsule

Primary outcomes

  1. Sleep Disturbances Scale for Children

    Time frame: 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.

  2. Recruitment

    Time frame: through study completion, an average of 6-months

    Quantitative number of patients consented per patients approached

  3. Retention

    Time frame: through study completion, an average of 30 days

    Quantitative number of participants completing trial procedures per patients consented

Secondary outcomes

  1. Adherence Quantitative

    Time frame: 1-month

    pill counts, report of using study medication at least 5/7 days per week

  2. Adherence Qualitative

    Time frame: 1-month

    participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention

  3. Pediatric Quality of Life Inventory Multidimensional Fatigue Scale

    Time frame: 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.

  4. Chronotype

    Time frame: 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)

  5. Sleep Latency

    Time frame: 1-month

    actigraphy measured time in minutes to fall asleep

  6. Total Sleep Time

    Time frame: 1-month

    actigraphy measured total time asleep in minutes

  7. Wake After Sleep Onset

    Time frame: 1-month

    actigraphy measured time in minutes awake after sleep onset

  8. Number of Night Awakenings

    Time frame: 1-month

    actigraphy measured number of instances awoken after sleep onset

  9. Sleep Efficiency

    Time frame: 1-month

    actigraphy measure percentage of nighttime period spent asleep

  10. Sleep Onset Time

    Time frame: 1-month

    time of day fell asleep presented as hours corresponding the the time of day from midnight as 0 hours (e.g., 22.5 hours means they fell asleep at 10:30 pm)

  11. Sleep Offset Time

    Time frame: 1-month

    time of day waking from nighttime sleep presented in hours from midnight as time 0 (e.g., 7.5 hours means they woke up at 7:30 am)

  12. Adverse Events Time 0

    Time frame: hospital discharge assessed up to 7 days

    Evaluation of adverse events asking participants to report any side effects of study interventions; Number of patients with any adverse event reported or noted on symptom screening checklist

  13. Adverse Events Time 1

    Time frame: 1-month

    Evaluation of adverse events asking participants to report any side effects of study interventions

Other outcomes

  1. Reason for Non-adherence

    Time frame: 1-month

    qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan

  2. Health Related Quality of Life

    Time frame: 1-month

    Pediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life.

  3. Cognitive Functioning

    Time frame: 1-month

    Behavior Rating Inventory of Executive Function, second edition (BRIEF-2); parent proxy report of everyday executive function, reported as standardized Global Executive Composite T-score, with higher scores indicating worse function. T-scores range from 0-100, with a mean of 50 and standard deviation of 10.

  4. Physical Functioning

    Time frame: 1-month

    Functional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup

  5. Anxiety

    Time frame: 1-month

    Patient Reported Outcome Measurement Information System (PROMIS) anxiety short form T-score with higher scores indicating worse outcome. T-scores range from 0 - 100, with a mean of 50 and standard deviation of 10.

  6. Depression

    Time frame: 1-month

    Patient Reported Outcome Measurement Information System (PROMIS) depression short form T-score with higher scores indicating worse outcome. T-scores range from 0-100, with a mean of 50 and standard deviation of 10.

  7. PROMIS Pain Behavior

    Time frame: 1-month

    Patient Reported Outcome Measurement Information System (PROMIS) pain behavior (T-score with mean of 50 and standard deviation of 10) parent report forms; Higher scores indicate worse pain outcomes

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes

Acronym: SMARTKids

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2021
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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