An interventional study of test of sensors for somnonaute device and test of sensors for uronaute device in Healthy, sponsored by BioSerenity. Terminated at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by BioSerenity · Not applicable, Interventional, and Other
BioSerenity suggests developing innovative solutions, from intelligent clothes which can be used in a hospital environment or at home. These textiles allow, in particular, to measure the biophysiological signals while letting to the participant the freedom pursue its daily activities.
BioSerenity has already developed two wearable wireless and portable medical devices: cardioskin with textile ECG electrods , and the Neuronaute with textile EEG, EMG electrods.
The aim of the study is to test these sensors to optimize their signal to integrate them in future Bioserenity devices like a somnonaute to help diagnosis of sleep disorders, like uronaute to help diagnosis of urination disorders, like toconaute to help monitoring of pregnancy. Others CE-marked sensors developed by others manufacturers will be tested to choose those that will be integrated in the Bioserenity devices.
The various alone sensors tested in the clinical trial (sensors of Bioserenity and the other manufacturers), will supply information which will allow to develop future devices. Some of these sensors will then be selected to integrate them.
The tests will be made according to the therapeutic area of the concerned device(plan). There are 5 therapeutic areas:
Cardiovascular (Cardioskin device), neurology ( Neuronaute device), urology ( Uronaute device), obstetrics ( Toconaute device), somnologie (Somnonaute device).
One subject would likely test either one sensor of a device or multiple sensors, either an entire device.
Exclusion Criteria:
monitoring with sensors
Device: test of sensors for somnonaute device
monitoring with sensors
Device: test of sensors for uronaute device
monitoring with sensors
Device: test of sensors for toconaute device
monitoring with sensors
Device: test of sensors for cardioskin device
monitoring with sensors
Device: test of sensors for neuronaute device
test of sensors
test of sensors
test of sensors
test of sensors
test of sensors
Sensor quality validation
Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns : eg amplitude of signal, regularity..
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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