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

Sponsor
Oregon Health and Science University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04932096
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
110
1
2
36
3.1

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

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Aug 31, 2025

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

  1. 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.

  2. Recruitment [through study completion, an average of 6-months]

    Quantitative number of patients consented per patients approached

  3. Retention [through study completion, an average of 6-months]

    Quantitative number of participants completing trial procedures per patients consented

Secondary Outcome Measures

  1. adherence quantitative [1-month]

    pill counts

  2. adherence qualitative [1-month]

    participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention

  3. 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.

  4. Chronotype [1-month]

    Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Each item assessed independently.

  5. sleep latency [1-month]

    actigraphy measured time in minutes to fall asleep

  6. total sleep time [1-month]

    actigraphy measured total time asleep in minutes

  7. wake after sleep onset [1-month]

    actigraphy measured time in minutes awake after sleep onset

  8. number of night awakenings [1-month]

    actigraphy measured number of instances awoken after sleep onset

  9. sleep efficiency [1-month]

    actigraphy measure percentage of nighttime period spent asleep

  10. sleep onset [1-month]

    time of day fell asleep

  11. sleep offset [1-month]

    time of day waking from nighttime sleep

  12. 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

  13. adverse events time 1 [2 weeks]

    Evaluation of adverse events asking participants to report any side effects of study interventions

  14. adverse events time 2 [1-month]

    Evaluation of adverse events asking participants to report any side effects of study interventions

Other Outcome Measures

  1. reason for non-adherence [1-month]

    qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan

  2. 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.

  3. 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.

  4. physical functioning [1-month]

    Functional Status Scale, range 6-30, with higher scores indicating worse function

  5. 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.

  6. 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.

  7. 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

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

Responsible Party:
Cydni Williams, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT04932096
Other Study ID Numbers:
  • GPEDI1282A
  • 1K23HL150229-01A1
First Posted:
Jun 18, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cydni Williams, Principal Investigator, Oregon Health and Science University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022