Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
研究概览
简要总结
A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and accelerometry. These measures are used to automatically detect epileptic seizures that are transmitted to a mobile phone-based system for alerts and recording.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female aged >18 years old
- •clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure
- •primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion
- •seizure frequency > 1 seizure/month during the last three months
- •signed the informed consent form
- •own a mobile phone device compatible with the embrace apps
- •able to use the device without help from caregivers
排除标准
- •patients aged less than 18 years old
- •epilepsy diagnosis remains uncertain
- •evidence of psychogenic non epileptic seizures
- •seizure frequency below 1/month during any of the three previous months
- •past-history of nickel allergy and contact dermatitis
- •did not sign the informed consent form
- •does not own mobile phone device compatible with the embrace apps
- •cognitive or behavioral impairment preventing compliance or correct use of the device and app.
研究组 & 干预措施
experimental group
The experimental group will make use of the Alert app that sends alarms to patients mobile devices, and if desired to the mobile devices of their caregivers. This group will also use the Mate app which is used as a seizure diary
干预措施: Embrace with Alert and Mate apps (Device)
Control group
The control group will only use the Mate app and not the Alert app. This group will thus not receive any notification, from the device, and will be unaware, of the devices performance
干预措施: Embrace with Mate app only (Device)
结局指标
主要结局
The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
时间窗: 3 month
The change between the QOLIE-31 questionnaire total score measured at the first and the final visit will serve as primary endpoint. The possible range of each scale's final score is from 0 to 100. higher scores reflect better quality of life.
次要结局
- Total number of true and false positives seizure detection(3 month)
- The usability total score of Embrace and Mate apps(3 month)
- The utility total score of the system in general(3 month)
- The mean change from Baseline of the total scores of seven Quality of Life in Epilepsy Inventory-31 subscales covering the following epilepsy-specific domains:(3 month)
研究者
Philippe Ryvlin
Head of Department of Clinical Neurosciences
Centre Hospitalier Universitaire Vaudois