ACTRN12619001585112尚未招募2 期
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 个研究点目标入组 120 人开始时间: 2019年11月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 8 Years 至 17 Years（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
研究者
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