Peer-reviewed article
Sleep Management and Recovery After TBI in Kids (SMART-Kids): Pilot Trial Using Melatonin.
Williams CN, Hall TA, Alberts H, Heierle J, Lim MM et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This pilot study tested whether melatonin plus sleep education could help children recover better sleep after traumatic brain injury. Twenty-one children aged 6 to 18 years received either melatonin or placebo for 30 days starting within 72 hours of hospital admission, along with sleep education materials. The treatment was feasible and safe, with most participants completing the study and taking the medication as prescribed, and preliminary results suggest melatonin may reduce sleep disturbances compared to placebo.
Key points
- Sleep disturbances occur in more than 50% of children after traumatic brain injury and are linked to worse cognitive and mental health outcomes
- Ninety-one percent of enrolled participants completed the 30-day study with 79% maintaining good adherence to medication
- No safety concerns were identified with melatonin use in this pediatric TBI population
- Placebo group showed a higher frequency of clinically important sleep disturbance scores at 30 days compared to melatonin group
- Actigraphy (objective sleep tracking) showed no significant differences between groups, though the study was small and not designed to prove effectiveness
Limitations
This is a small pilot study (21 participants) not powered to definitively prove melatonin's effectiveness, and objective sleep measures (actigraphy) did not show significant differences between groups. The findings provide preliminary evidence for future larger studies but cannot yet establish melatonin as a proven treatment for post-TBI sleep problems in children.
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 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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Melatonin administered daily for 30 days starting within 72 hours of TBI hospital admission, combined with sleep education handouts and access to educational videos
- Population
- Children aged 6 to 18 years admitted to hospital with traumatic brain injury
Key finding
21 of 53 eligible patients consented (40% enrollment rate); 19 completed the study (91% completion rate)