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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioskin | Experimental | 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. |
|
| Neuronaute | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioskin | Device | Subjects have a monitoring with cardioskin and comparator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sensor quality validation | Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..) | 2 month |
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Inclusion Criteria:
• man or women of at least 18 years old
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICM | Paris | 75013 | France |
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| Neuronaute |
| Device |
Subjects have a monitoring with Neuronaute and comparator |
|