SMARTKids: Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Study Details
Study Description
Brief 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. 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, 2-weeks, 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Melatonin (melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days) |
Drug: melatonin
melatonin supplementation
|
Placebo Comparator: Placebo Placebo |
Other: placebo
microcrystalline cellulose filled capsule
|
Outcome Measures
Primary Outcome Measures
- sleep disturbance [1-month]
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.
- Recruitment [through study completion, an average of 6-months]
Quantitative number of patients consented per patients approached
- Retention [through study completion, an average of 6-months]
Quantitative number of participants completing trial procedures per patients consented
Secondary Outcome Measures
- adherence quantitative [1-month]
pill counts
- adherence qualitative [1-month]
participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention
- Fatigue [1-month]
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.
- Chronotype [1-month]
Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Each item assessed independently.
- sleep latency [1-month]
actigraphy measured time in minutes to fall asleep
- total sleep time [1-month]
actigraphy measured total time asleep in minutes
- wake after sleep onset [1-month]
actigraphy measured time in minutes awake after sleep onset
- number of night awakenings [1-month]
actigraphy measured number of instances awoken after sleep onset
- sleep efficiency [1-month]
actigraphy measure percentage of nighttime period spent asleep
- sleep onset [1-month]
time of day fell asleep
- sleep offset [1-month]
time of day waking from nighttime sleep
- adverse events time 0 [hospital discharge assessed up to 7 days]
Evaluation of adverse events asking participants to report any side effects of study interventions
- adverse events time 1 [2 weeks]
Evaluation of adverse events asking participants to report any side effects of study interventions
- adverse events time 2 [1-month]
Evaluation of adverse events asking participants to report any side effects of study interventions
Other Outcome Measures
- reason for non-adherence [1-month]
qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan
- health related quality of life [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.
- cognitive functioning [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.
- physical functioning [1-month]
Functional Status Scale, range 6-30, with higher scores indicating worse function
- anxiety [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.
- depression [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.
- pain [1-month]
Patient Reported Outcome Measurement Information System (PROMIS) pain intensity (raw score out of 10), and pain behavior (T-score with mean of 50 and standard deviation of 10) parent report forms; Higher scores indicate worse pain outcomes
Eligibility Criteria
Criteria
Inclusion:
-
Children age ≥6 years and <19 years
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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
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Admission to Oregon Health & Science University Hospitals
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Deemed likely to survive hospitalization by clinical care team
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Able to tolerate enteral medications within 72 hours of admission
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Child participant resides with parent or legal guardian
Exclusion:
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Lack stable means of communication with study team (phone, email, mailing address)
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Abusive trauma suspected or confirmed
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Dialysis
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Extracorporeal support (e.g. ECMO)
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Significant liver injury defined as >2x normal levels for AST or ALT
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Clinical team safety concerns with use of intervention
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Pregnancy
-
Prisoners
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Cydni Williams, MD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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). pii: zsaa083. doi: 10.1093/sleep/zsaa083.
- Poppert 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.
- Williams 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.
- GPEDI1282A
- 1K23HL150229-01A1