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Clinical Trials/ACTRN12619001585112
ACTRN12619001585112
Not yet recruiting
Phase 2

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

The Children's Hospital Institute of Sports Medicine0 sites120 target enrollmentNovember 18, 2019
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ConditionsPost-Concussion Clinical InsomniaNeurological - Other neurological disordersInjuries and Accidents - Other injuries and accidents

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Post-Concussion Clinical Insomnia
Sponsor
The Children's Hospital Institute of Sports Medicine
Enrollment
120
Status
Not yet recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 18, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Children's Hospital Institute of Sports Medicine

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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