Healthy
Conditions
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.
Interventions
DEVICECardioskin
Subjects have a monitoring with cardioskin and comparator
DEVICENeuronaute
Subjects have a monitoring with Neuronaute and comparator
Sponsors
BioSerenity
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor quality validation | 2 month | Signal is considered as of good quality not good quality regarding criteria of signal patterns (eg.beat detection, beats variability..) |
Countries
France
Outcome results
None listed