NCT02236845已完成不适用
Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia
Lacrima Medical LTD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of adverse events
研究概览
简要总结
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Adult subjects, 18 years of age and older at screening
- •Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2
- •Total score of Pittsburgh Sleep Quality questionnaire is > 5
- •Latency to persistent sleep is > 30 minutes based on Pittsburgh questionnaire
- •Able to understand and provide written informed consent
排除标准
- •Patients using any pharmacological treatments for insomnia for 14 days
- •Patients currently using stimulants drugs 7 days
- •Patients currently using antidepressants causing sleepiness
- •Patients who are unable to commit to avoid consumption alcohol during the study
- •Patients who are unable to commit to avoid consumption caffeine after 12 pm
- •Patients who have a clinical significant or unstable medical or surgical condition
结局指标
主要结局
Rate of adverse events
时间窗: Up to 37 days
次要结局
- Change in sleep latency time based on sleep actigraph(28 days)
研究者
研究点 (1)
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