None listed
Conditions
Brief summary
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.
Interventions
Participants will be randomly allocated to one of two treatment groups for a duration of 4 weeks: sleep hygiene education (standard care) or sleep hygiene education plus melatonin (intervention). Participants randomised to the intervention group will be given a prescription for melatonin supply and instructed on its administration. Melatonin will be given in wafer form and administered sublingually, with a dosage of either 3mg, 6mg or 9mg depending on participant size. Participants will be instr
Participants will be randomly allocated to one of two treatment groups for a duration of 4 weeks: sleep hygiene education (standard care) or sleep hygiene education plus melatonin (intervention). Participants randomised to the intervention group will be given a prescription for melatonin supply and instructed on its administration. Melatonin will be given in wafer form and administered sublingually, with a dosage of either 3mg, 6mg or 9mg depending on participant size. Participants will be instructed to take melatonin 1 hour before retiring during the 4 week intervention period. The Sleep Hygiene Index (assessed on a weekly basis) and a sleep diary will be given to participants, monitoring their adherence to engaging in sleep-promoting behaviours during the intervention period. The sleep diary also includes a question on supplement intake to assist with sleep, which allows compliance to melatonin to be measured.
Sponsors
The Children's Hospital Institute of Sports Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
- Children and adolescent youth aged 8-17 years with a diagnosed concussion; - Patients with sleep disturbance defined by an Insomnia Severity Index (ISI) > 7; - Patients with a concussive injury presenting to the Kids Concussion Service (KCS) at the Children's Hospital Institute of Sports Medicine (CHISM).
Exclusion criteria
Patients with: - No to minimal sleep disturbance (defined by ISI<7); - Pre-injury chronic sleep disorder; - Complex sleep disorder determined from sleep questionnaires; - Neurological disorder unrelated to concussive injury; - Attention Deficit Hyperactivity Disorder (ADHD); - Chronic behavioural disorder; - Psychiatric condition.
Outcome results
None listed