Sleep Management and Recovery After TBI in Kids (SMART-Kids): Pilot Trial Using Melatonin
Abstract
Objective: Sleep disturbances after pediatric traumatic brain injury (TBI) occur in more than 50% of survivors and portend worse cognitive and psychosocial outcomes. We aimed to determine feasibility and acceptability of an early melatonin and sleep education intervention study after TBI.
Patients and methods: We conducted a pilot randomized, double-blinded placebo-controlled trial of melatonin for 30 days vs placebo in children aged more than 6 to 18 years started within 72 hours of TBI admission. All participants received sleep education handouts with access to short videos. Covariate adaptive randomization was used to balance groups by age and TBI severity. Primary outcomes were feasibility and acceptability. Secondary effectiveness sleep outcomes were explored with the Sleep Disturbances Scale for Children (SDSC) T-scores and actigraphy.
Results: Twenty-one (40%) of 53 approached patients consented (median age, 10.7 years), and 19 (91%) completed the study. Fifteen (79%) reported adherence (defined ≥5 of 7 days per week for medication), and 15 provided usable actigraphy data. We found high acceptability with no safety concerns identified. Randomization procedures were successful with no between-group differences observed. A higher frequency of clinically important SDSC scores (T-score ≥60, indicating moderate or greater risk for sleep disorder) at 30 days were found with placebo vs melatonin. Actigraphy showed nonsignificant differences.
Conclusion: Melatonin paired with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 53 participants or records.
Read the paper
Related studies
- A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Evaluating the Evidence Base of Melatonin, Light Exposure, Exercise, and Complementary and Alternative Medicine for Patients with Insomnia Disorder
- Use of Melatonin and/on Ramelteon for the Treatment of Insomnia in Older Adults: A Systematic Review and Meta-Analysis
- Influence of evening light exposure on polysomnographically assessed night-time sleep: A systematic review with meta-analysis
- Use of melatonin in children and adolescents with idiopathic chronic insomnia: a systematic review, meta-analysis, and clinical recommendation
- Significant potential of melatonin therapy in Parkinson’s disease – a meta-analysis of randomized controlled trials
- Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.