NCT02077036Unknown不适用
Narcolepsy - New Potential Treatment
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in scale Epworth Sleep Scale (ESS)
研究概览
简要总结
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Diagnosed with narcolepsy (diagnose code G47.4)
- •16 - 60 years of age
- •MSLT has shown hypersomnia (sleeping latency < 8 min) & 1 episode REM
- •HLA-type associated with increased occurrence of narcolepsy
排除标准
- •Reduced cognitive function
- •Other relevant organ disease (that could affect the study results or put the patient at risk)
- •Ongoing bacterial infection in the nose
- •Comorbidity that can increase the risk of bleeding
- •Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck
- •Known pronounced septal deviation
- •Known allergy to polyvinylchloride or medicinal liquid paraffin
- •Women not using adequate contraceptives
- •Participated in a clinical investigational drug trial within the previous 30 days
研究组 & 干预措施
Inactive medical device
Placebo Comparator
干预措施: Kinetic Oscillation Stimulation Device in placebo mode (Device)
Active medical device
Experimental
干预措施: Kinetic Oscillation Stimulation Device (Device)
结局指标
主要结局
Change in scale Epworth Sleep Scale (ESS)
时间窗: 15-21 days
Change in ESS scale between baseline before treatment and at 15-21 days after treatment.
次要结局
- Change in multiple sleep latency test (MSLT)(14 days)
研究者
Lars Hyllienmark
Associate professor, consultant in neurology and clinical neurophysiology
Karolinska University Hospital
研究点 (1)
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