A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 8
- 主要终点
- Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
研究概览
简要总结
Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.
详细描述
Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.
A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.
The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 (4+ years old) with refractory epilepsy who are admitted to the hospital for clinically-indicated long-term video-EEG assessment or presurgical evaluation, and a high likelihood of experiencing seizures during the EMU Phase
- •For subjects continuing into the Home Phase: successful recording of their habitual seizures with Sensor Dot during the EMU Phase
- •For subjects continuing into the Home Phase: the ability to keep an e-diary
排除标准
- •Known allergies to any of the biopotential electrodes or adhesives used as part of the study protocol
- •Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device because Sensor Dot contains magnets that could interfere with the operation of these devices
- •Women who are pregnant
结局指标
主要结局
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
时间窗: up to two weeks
F1-score as determined by expert reviewers
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
时间窗: up to two weeks
F1-score as determined by expert reviewers
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
时间窗: up to two weeks
F1-score as determined by expert reviewers
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
时间窗: up to two weeks
F1-score as determined by expert reviewers
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
时间窗: up to two weeks
F1-score as determined by expert reviewers
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
时间窗: up to two weeks
F1-score as determined by expert reviewers
次要结局
- Sensor Dot usability(up to two weeks)
- To assess the usability of the seizure e-diary(up to two weeks)
- To evaluate the accuracy of automated seizure detection algorithms(2 years)
- To assess seizure duration(up to two weeks)
- Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations(up to 2 weeks)
- Sensor Dot Performance(up to 2 weeks)