Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- BioSerenity
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Sensor quality validation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •man or women of at least 18 years old
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Sensor quality validation
Time Frame: 2 month
Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..)