ICM
Paris, 75013, France
NCT Number: NCT03725462
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects have a monitoring with cardioskin and comparator
Subjects have a monitoring with Neuronaute and comparator
Time frame: 2 month
Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..)
BioSerenity
Industry
Acronym: STREAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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