EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Comparison of video-EEG to EpiWatch Results for PPA
研究概览
简要总结
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).
详细描述
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).
Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to a site EMU for video-EEG monitoring
- •Age five and older at the time of enrollment
- •Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures
- •Willing and able to comply with study procedures
排除标准
- •Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors
- •Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch
- •Inability or unwillingness to comply with study procedures
结局指标
主要结局
Comparison of video-EEG to EpiWatch Results for PPA
时间窗: 6 months
Lower bound of 95% confidence interval of the positive percent agreement (PPA) \> 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
Comparison of video-EEG to EpiWatch results for FAR
时间窗: 6 months
Upper bound of 95% confidence interval of the false alarm rate (FAR) \<.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
次要结局
- Pediatric Ambulation Positive Percent Agreement(6 months)
- Pediatric Ambulation False Alarm Rate(6 months)