Clinical trial NCT04932096: Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Official title: Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Traumatic Brain Injury
Critical Illness
Sleep
Keywords: pediatric
traumatic brain injury
melatonin
sleep
intervention
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: sleep disturbance
timeFrame: 1-month
measure: Recruitment
timeFrame: through study completion, an average of 6-months
measure: Retention
timeFrame: through study completion, an average of 6-months
Secondary outcomes:
measure: adherence quantitative
timeFrame: 1-month
measure: adherence qualitative
timeFrame: 1-month
measure: Fatigue
timeFrame: 1-month
measure: Chronotype
timeFrame: 1-month
measure: sleep latency
timeFrame: 1-month
measure: total sleep time
timeFrame: 1-month
measure: wake after sleep onset
timeFrame: 1-month
measure: number of night awakenings
timeFrame: 1-month
measure: sleep efficiency
timeFrame: 1-month
measure: sleep onset
timeFrame: 1-month
measure: sleep offset
timeFrame: 1-month
measure: adverse events time 0
timeFrame: hospital discharge assessed up to 7 days
measure: adverse events time 1
timeFrame: 1-month
Other outcomes:
measure: reason for non-adherence
timeFrame: 1-month
measure: health related quality of life
timeFrame: 1-month
measure: cognitive functioning
timeFrame: 1-month
measure: physical functioning
timeFrame: 1-month
measure: anxiety
timeFrame: 1-month
measure: depression
timeFrame: 1-month
measure: pain
timeFrame: 1-month
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Cydni Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.