NCT05439876已完成2 期
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Sleep Onset Latency
研究概览
简要总结
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
详细描述
Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
排除标准
- •Children who are bedridden with limited mobility
- •Children with liver or kidney dysfunction
- •Children on hypnotics, antidepressants, or anxiolytics within 4 weeks before the baseline clinic visit
- •Adolescent girls who are pregnant or breastfeeding
- •Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial
研究组 & 干预措施
Melatonin
Experimental
Melatonin
干预措施: Melatonin (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep Onset Latency
时间窗: 4 weeks
Sleep onset latency was assessed by actigraphy.
次要结局
- Children's Sleep Disturbance(4 weeks)
研究者
研究点 (1)
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