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

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumatic Brain Injury, Critical Illness, Sleep

Intervention / Treatment
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* Drug: melatonin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days) | Drug: melatonin<br>* melatonin supplementation<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: placebo<br>* microcrystalline cellulose filled capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep disturbance | Sleep Disturbances Scale for Children: 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. | 1-month | 
| Recruitment | Quantitative number of patients consented per patients approached | through study completion, an average of 6-months | 
| Retention | Quantitative number of participants completing trial procedures per patients consented | through study completion, an average of 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence quantitative | pill counts | 1-month | 
| adherence qualitative | participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention | 1-month | 
| Fatigue | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS); 18 item parent proxy report of fatigue. Scores range 0-100 with higher scores indicating better function and less fatigue. | 1-month | 
| Chronotype | Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Each item assessed independently. | 1-month | 
| sleep latency | actigraphy measured time in minutes to fall asleep | 1-month | 
| total sleep time | actigraphy measured total time asleep in minutes | 1-month | 
| wake after sleep onset | actigraphy measured time in minutes awake after sleep onset | 1-month | 
| number of night awakenings | actigraphy measured number of instances awoken after sleep onset | 1-month | 
| sleep efficiency | actigraphy measure percentage of nighttime period spent asleep | 1-month | 
| sleep onset | time of day fell asleep | 1-month | 
| sleep offset | time of day waking from nighttime sleep | 1-month | 
| adverse events time 0 | Evaluation of adverse events asking participants to report any side effects of study interventions | 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 | 1-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, traumatic brain injury, melatonin, sleep, intervention