Sleep Management and Recovery After TBI in Kids (SMART-Kids): Pilot Trial Using Melatonin

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.

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.

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.

Melatonin paired with sleep education early during hospitalization and continued for 30 days is feasible and acceptable. Although not powered for effectiveness, results suggest melatonin may reduce sleep disturbances by clinically meaningful margins after TBI hospitalization, and results can be used as effect size estimates for a larger study.