Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioSerenity
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sensor quality validation
研究概览
简要总结
The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.
It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.
详细描述
With this study evulating the performance of two wireless, connected device of electrophysiological signal monitoring. The Cardioskin monitors electrocardiogram signal. The Neuronaute monitors electroencephalogram, electromyogram and electrocardiogram.
This study will permit to optimize the devices performance.
To the study, subjects of at least 18 years old will test Cardioskin and or Neuronaute device, without randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- •man or women of at least 18 years old
排除标准
- •Injuries or wounds on the body and scalp
- •Participant unable to follow the procedure of use, the judgment of the investigator
- •Brain surgery that occurred less than a week ago
- •Known allergy to silver, polyamide, silicone, synthetic materials
- •Sensory disorders that make the subject insensitive to pain
- •behavioral problems that make the subject excessively agitated or aggressive;
- •Cardiorespiratory disorders that may be aggravated by mild compression of thorax
- •Subject equipped with an electrical stimulation device;
- •Inappropriate anthropometric parameters to textile sizes
- •Clinically detectable or known pain of the subject;
- •Current participation in a clinical trial or participation in a previous clinical study including a period of deficiency not yet completed at the time of this clinical trial
- •Predisposition to tension headaches (the compression exerted by the cap may in some cases trigger a headache);
- •Use of the Cardioskin device for resuscitation or intensive care.
- •Participant with defibrillator, vagus nerve stimulator or other high frequency surgical device
研究组 & 干预措施
Cardioskin
Subjects performed a monitoring with Cardioskin. The performance is evaluated either by a comparison with a gold standard, either by a comparison with anterior version of Cardioskin, either by an opinion of an expert.
干预措施: Cardioskin (Device)
Neuronaute
Subjects performed a monitoring with Neuronaute. The performance is evaluated either by a comparison with a gold standard, either by a comparison with anterior version of Neuronaute, either by an opinion of an expert.
干预措施: Neuronaute (Device)
结局指标
主要结局
Sensor quality validation
时间窗: 2 month
Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..)
次要结局
未报告次要终点