A Randomised Controlled Trial of Treatment for Post-Concussion Clinical Insomnia in Children and Adolescents: The Effect of Melatonin Plus Sleep Hygiene Education Versus Education Alone

Despite sleep problems being one of the most common symptoms experienced following concussion in children and adolescents, there is little scientific evidence for its treatment. Therefore, this study aims to determine: 1) the basic characteristics of sleep disturbance in children and adolescents following concussion; 2) the impact of post-concussion clinical insomnia (PCCI) on recovery; and 3) if the addition of melatonin to sleep education can improve patient outcome. Only children and adolescents with sleep disturbance following concussion, aged 8-17 years, will be eligible to participate in the study. Eligible participants will be randomly allocated to either Treatment Group 1 (i.e. sleep hygiene education) or Treatment Group 2 (i.e. sleep hygiene education plus melatonin) for a duration of 4 weeks, and will be monitored throughout this period until they have recovered. The findings from this study will facilitate a better understanding of the nature of sleep problems in children and adolescents following concussion, and will also provide scientific evidence of whether current interventions are effective in their treatment.