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

Critical Illness Clinical Trial

— SMARTKids  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932096
• Other study ID #: GPEDI1282A
• Secondary ID: 1K23HL150229-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: Cydni N Williams, MD
• Phone: 503-494-5522
• Email: willicyd[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Critical Illness
• Sleep
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• melatonin
melatonin supplementation

Other:
• placebo
microcrystalline cellulose filled capsule

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	reason for non-adherence	qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan	1-month
Other	health related quality of life	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.	1-month
Other	cognitive functioning	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.	1-month
Other	physical functioning	Functional Status Scale, range 6-30, with higher scores indicating worse function	1-month
Other	anxiety	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.	1-month
Other	depression	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.	1-month
Other	pain	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	1-month
Primary	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
Primary	Recruitment	Quantitative number of patients consented per patients approached	through study completion, an average of 6-months
Primary	Retention	Quantitative number of participants completing trial procedures per patients consented	through study completion, an average of 6-months
Secondary	adherence quantitative	pill counts	1-month
Secondary	adherence qualitative	participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention	1-month
Secondary	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
Secondary	Chronotype	Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Each item assessed independently.	1-month
Secondary	sleep latency	actigraphy measured time in minutes to fall asleep	1-month
Secondary	total sleep time	actigraphy measured total time asleep in minutes	1-month
Secondary	wake after sleep onset	actigraphy measured time in minutes awake after sleep onset	1-month
Secondary	number of night awakenings	actigraphy measured number of instances awoken after sleep onset	1-month
Secondary	sleep efficiency	actigraphy measure percentage of nighttime period spent asleep	1-month
Secondary	sleep onset	time of day fell asleep	1-month
Secondary	sleep offset	time of day waking from nighttime sleep	1-month
Secondary	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
Secondary	adverse events time 1	Evaluation of adverse events asking participants to report any side effects of study interventions	1-month

External Links

•   Principal Investigator program website that will be updated regularly for PI contact information and study related materials