NCT04615442已完成不适用
ECV - Epihunter Clinical Validation
Epihunter NV5 个研究点 分布在 4 个国家目标入组 102 人开始时间: 2020年5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
- 102
- 试验地点
- 5
- 主要终点
- Sensitivity for electrographic seizures of study device compared to video EEG
研究概览
简要总结
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should have an indication of having absence seizures
- •Subjects should be admitted for video EEG monitoring as part of their clinical practice
- •Age > 4 years
排除标准
- •Head circumference should be compatible for wearable EEG device (40-70cm)
- •The subject should be able to understand instructions and refrain from removing the device from its head
结局指标
主要结局
Sensitivity for electrographic seizures of study device compared to video EEG
时间窗: 9 months
The sensitivity for electrographic seizures by the study device compared to manually annotated electrographic seizures on non-video EEG is \> 0.90 (median sensitivity per patient)
Number of false alarms by study device per hour
时间窗: 9 months
The number of false alarms by the study device \< 0.1 per hour (median false detection rate per recording)
次要结局
- Feasibility testing of automated behavioral testing triggered by automated detection(3 months)
研究者
研究点 (5)
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