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

Phase 2

Recruiting

• Conditions: Traumatic Brain Injury; Critical Illness; Sleep
• Interventions: Drug: melatonin; Other: placebo

• Registration Number: NCT04932096
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-18
• Study Start: 2023-01-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	melatonin	(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)
Placebo	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
adherence qualitative	1-month	participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention
adherence quantitative	1-month	pill counts
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	1-month	Evaluation of adverse events asking participants to report any side effects of study interventions

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States