Trials / Terminated
TerminatedNCT03805243
Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles
Evaluation of the Signals électrophysiologiques Measured by Intelligent Textiles
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- BioSerenity · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | test of sensors for somnonaute device | test of sensors |
| DEVICE | test of sensors for uronaute device | test of sensors |
| DEVICE | test of sensors for toconaute device | test of sensors |
| DEVICE | test of sensors for neuronaute device | test of sensors |
| DEVICE | test of sensors for cardioskin device | test of sensors |
Timeline
- Start date
- 2019-11-29
- Primary completion
- 2020-12-21
- Completion
- 2020-12-21
- First posted
- 2019-01-15
- Last updated
- 2021-11-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03805243. Inclusion in this directory is not an endorsement.