A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Body position detection
研究概览
简要总结
The goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress.
Primary Objective
Milestones:
Feasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS.
Secondary Objective Detect the postictal prone position with an accuracy of 100%.
详细描述
This is an exploratory study with the goal of using a commercial bed sheet sensor and software with Soterya Inc's Korus software to identify GTCs in an inpatient setting.
50 patients will be monitored at the BWH EMU with the goal of capturing 20 GTCS events.
The sheet sensor used will be the Sensor Products Tactilus High Performance Mattress Sensor System with the accompanying Tactilus Software. Pressure sensor data will be processed by Soterya Inc's Korus Software. The sensor system is a piezoresistive device that is already in commercial use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults 18 years of age or older admitted to the BWH EMU with drug-resistant epilepsy, defined by the failure of at least two anti-seizure medications and a documented history of electroclinical seizures
排除标准
- •Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)
- •Patients admitted for medication adjustment only
结局指标
主要结局
Body position detection
时间窗: 5 seconds
Correct detection of one of 4 cardinal body positions: prone, supine, left, right
Number of subjects correctly repositioned from the prone to recovery position
时间窗: 30 seconds
We will measure the performance of Korus to successfully reposition the subject from the prone to recovery position
次要结局
未报告次要终点
研究者
Jong Woo Lee
Associate Professor of Neurology
Brigham and Women's Hospital