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

Phase 2

• Conditions: Post-Concussion Clinical Insomnia; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001585112
• Lead Sponsor: The Children's Hospital Institute of Sports Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified