Traumatic Brain InjuryPhase 2SMARTKidsNCT04932096
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
A Phase 2 study testing melatonin in people with Traumatic Brain Injury and Critical Illness, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Traumatic Brain Injury, Critical Illness, Sleep
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 1 Mar 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes
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.
- Conditions
- Traumatic Brain Injury, Critical Illness, Sleep
- Being tested
- melatonin, placebo
- Keywords
- pediatric, traumatic brain injury, melatonin, sleep, intervention
- Medical subject headings
- Brain Injuries, Traumatic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
melatonin supplementation
placeboOther
microcrystalline cellulose filled capsule
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | (melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days) Receives: Drug: melatonin |
| Placebo | Placebo comparator | Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbances Scale for Children
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.
Measured: 1-month
Recruitment
Quantitative number of patients consented per patients approached
Measured: through study completion, an average of 6-months
Retention
Quantitative number of participants completing trial procedures per patients consented
Measured: through study completion, an average of 30 days
Secondary outcomes (13)
Adherence Quantitative
pill counts, report of using study medication at least 5/7 days per week
Measured: 1-month
Adherence Qualitative
participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention
Measured: 1-month
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
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.
Measured: 1-month
Chronotype
Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness)
Measured: 1-month
Sleep Latency
actigraphy measured time in minutes to fall asleep
Measured: 1-month
Total Sleep Time
actigraphy measured total time asleep in minutes
Measured: 1-month
Wake After Sleep Onset
actigraphy measured time in minutes awake after sleep onset
Measured: 1-month
Number of Night Awakenings
actigraphy measured number of instances awoken after sleep onset
Measured: 1-month
Sleep Efficiency
actigraphy measure percentage of nighttime period spent asleep
Measured: 1-month
Sleep Onset Time
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)
Measured: 1-month
Sleep Offset Time
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)
Measured: 1-month
Adverse Events Time 0
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
Measured: hospital discharge assessed up to 7 days
Adverse Events Time 1
Evaluation of adverse events asking participants to report any side effects of study interventions
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start2 Jan 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Cydni Williams, Oregon Health and Science University
- Investigators
- Cydni Williams, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932096
- Sponsor's protocol ID
- GPEDI1282A
- Other IDs
- 1K23HL150229-01A1
- Acronym
- SMARTKids
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2021
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Basic tabular results will be entered into clinicaltrials.gov within 1 year of primary completion of the study. We will make participant data available to researchers once thoroughly de-identified and approved by our institutional review board within 1 year of study completion. Data will be made available on requests made directly to the Principal Investigator.
Publications
Luther M, Poppert Cordts KM, Williams CN. Sleep disturbances after pediatric traumatic brain injury: a systematic review of prevalence, risk factors, and association with recovery. Sleep. 2020 Oct 13;43(10):zsaa083. doi: 10.1093/sleep/zsaa083.
PubMed 32328648Poppert Cordts KM, Hall TA, Hartman ME, Luther M, Wagner A, Piantino J, Guilliams KP, Guerriero RM, Jara J, Williams CN. Sleep Measure Validation in a Pediatric Neurocritical Care Acquired Brain Injury Population. Neurocrit Care. 2020 Aug;33(1):196-206. doi: 10.1007/s12028-019-00883-5.
PubMed 31797275Williams CN, Hartman ME, McEvoy CT, Hall TA, Lim MM, Shea SA, Luther M, Guilliams KP, Guerriero RM, Bosworth CC, Piantino JA. Sleep-Wake Disturbances After Acquired Brain Injury in Children Surviving Critical Care. Pediatr Neurol. 2020 Feb;103:43-51. doi: 10.1016/j.pediatrneurol.2019.08.010. Epub 2019 Aug 26.
PubMed 31735567