Efficacy of Melatonin for Sleep Disturbance in Children with Persistent Post-Concussion Symptoms: Secondary Analysis of a Randomized Controlled Trial.
Study Goal
The researchers aimed to evaluate the efficacy of melatonin for treating sleep disturbances in youth with persistent post-concussion symptoms (PPCS) following mild traumatic brain injury (mTBI).
Results Summary
The study compared melatonin (3 mg and 10 mg) with placebo for improving sleep-related problems (SRPs) in youth with PPCS. Primary outcomes measured changes in SRPs using the Post-Concussion Symptom Inventory (PCSI), while secondary outcomes included actigraphy-measured sleep efficiency, duration, onset latency, and wake-after-sleep-onset.
Population
Youth aged 8-18 years with PPCS and significant sleep-related problems at 4-6 weeks post-injury.
Effective Dosage
3 mg and 10 mg melatonin.
Duration
2 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin treatment | neutral | sleep disturbance | children with persistent post-concussion symptoms (PPCS) | - | is often recommended | #1 |
melatonin | neutral | sleep disturbance | youth with PPCS following mild traumatic brain injury (mTBI) | - | evaluate the efficacy of treatment | #2 |
melatonin | neutral | PPCS | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | compared with placebo | #3 |
melatonin 3 mg | neutral | - | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | treatment groups | #4 |
melatonin 10 mg | neutral | - | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | treatment groups | #5 |
placebo | neutral | - | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | treatment groups | #6 |
melatonin | neutral | SRPs measured using the Post-Concussion Symptom Inventory (PCSI) | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | primary outcome was change | #7 |
melatonin | neutral | actigraphy sleep efficiency | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | secondary outcomes included change | #8 |
melatonin | neutral | actigraphy sleep duration | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | secondary outcomes included change | #9 |
melatonin | neutral | actigraphy sleep onset latency | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | secondary outcomes included change | #10 |
melatonin | neutral | actigraphy wake-after-sleep-onset | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | secondary outcomes included change | #11 |
melatonin | neutral | Behaviour Assessment for Children (2nd edition) | Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury | - | behavior was measured | #12 |
Sleep disturbances are commonly reported in children with persistent post-concussion symptoms (PPCS). Melatonin treatment is often recommended, yet supporting evidence is scarce. We aimed to evaluate the efficacy of treatment with melatonin for sleep disturbance in youth with PPCS following mild traumatic brain injury (mTBI). This article is a secondary analysis of a clinical trial of melatonin compared with placebo to treat PPCS. Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury were eligible. Exclusion criteria: significant medical/psychiatric history; previous concussion/mTBI within 3 months. Treatment groups were: placebo, melatonin 3 mg, or melatonin 10 mg. Primary outcome was change in SRPs measured using the Post-Concussion Symptom Inventory (PCSI) after 2 weeks of treatment. Secondary outcomes included change in actigraphy sleep efficiency, duration, onset latency, and wake-after-sleep-onset. Behavior was measured using Behaviour Assessment for Children (2nd edition). Seventy-two participants (mean age 14.0, standard deviation [SD] = 2.6) years; 60% female) with PPCS and significant sleep disturbance were included in the secondary analysis: placebo (