Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Comparison of Video-EEG to Embrace System
研究概览
简要总结
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
详细描述
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG.
A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).
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
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine vEEG monitoring related to seizures. Patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history.
排除标准
- •Patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission).
- •Women who are pregnant.
- •Patients who are known or suspected to have a history of PNES only.
- •Patients with known allergic reactions to nickel or stainless steel
- •Infants who were born pre-term and may not have fully developed skin
结局指标
主要结局
Comparison of Video-EEG to Embrace System
时间窗: 6 months
Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to Video-EEG adjudicated by 3 independent expert reviewers. A majority rules approach is used to identify convulsive seizures.
次要结局
- False Alarm Rate Tolerability(6 months)
- Patient Care Improvement Measure(6 months)
- Embrace System Usability(6 months)
- Alarm System Comparison(6 months)