NCT00653562已完成4 期
Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Sleep latency
研究概览
简要总结
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
详细描述
The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
排除标准
- •Patients with schizophrenia or manic-depressive illness
- •Patients with insomnia caused by physical diseases
- •Patients having a history of hypersensitivity to zolpidem
- •Patients with attention-deficit hyperactivity disorder
研究组 & 干预措施
1
Experimental
Patients will receive placebo in one part and zolpidem in the other part
干预措施: zolpidem (Drug)
结局指标
主要结局
Sleep latency
时间窗: 2 days
次要结局
- Time of intermediate awaking(2 days)
- Patient impression(2 days)
- Total hours of sleep(2 days)
- Frequency of intermediate awaking(2 days)
研究者
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