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临床试验/NCT06180538
NCT06180538尚未招募不适用

EPIVIEWS: Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

Royal College of Surgeons, Ireland0 个研究点目标入组 50 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Quality of Life in Epilepsy Inventory (QOLIE-31)

研究概览

简要总结

The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

详细描述

Epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. Any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (SUDEP). As such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life.

New technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. These devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. One example of this device is the Empatica Embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. This relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers.

Whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. It remains unclear on the value that they can offer to patients. The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The participant is over the age of 18
  • The participant has access to a smartphone
  • The participant has a history of generalised tonic-clonic seizures in the past year

排除标准

  • The participant lacks capacity to give informed consent (e.g. has intellectual disability)
  • The participant is a paediatric patient (aged below 18)

结局指标

主要结局

Quality of Life in Epilepsy Inventory (QOLIE-31)

时间窗: Prior to admission

次要结局

未报告次要终点

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Sponsor

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