CTRI/2024/10/074931尚未招募2 期
To study the effectiveness of melatonin supplementation on sleep and cognition in children with ADHD experiencing sleep disturbances
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Melatonin supplementation will improve sleep and cognition among children aged 6 to 16 years diagnosed with Attention-Deficit/Hyperactivity disorder experiencing Sleep disturbances
研究概览
简要总结
To investigate the effectiveness of melatonin treatment on sleep and cognition in children aged 6 to 16 years with attention deficit hyperactivity disorder with sleep problems attending child and adolescent psychiatry OPD
Melatonin supplementation will improve sleep and cognition among children aged 6 to 16 years diagnosed with Attention Deficit Hyperactivity disorder experiencing Sleep disturbances
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with ADHD willing to participate after taking a written informed consent from the primary caregiver with the assent of the patient Children between ages 6 and 16 years Experiencing sleep disturbances assessed using a cutoff score of 41 on the CSHQ scale Treatment for ADHD continued as usual on stable dose of medication for past 4 weeks.
排除标准
- •Children diagnosed with intellectual disability Children diagnosed with autism spectrum disorder Children diagnosed with epilepsy or any other neurological condition.
结局指标
主要结局
Melatonin supplementation will improve sleep and cognition among children aged 6 to 16 years diagnosed with Attention-Deficit/Hyperactivity disorder experiencing Sleep disturbances
时间窗: Baseline | 2 weeks | 4 weeks | 6 weeks
次要结局
- Not applicable(Not applicable)
研究者
Dr Ritwick Tripathi
King George medical university
研究点 (1)
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