Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles (DATASET)

Evaluation of the Signals électrophysiologiques Measured by Intelligent Textiles

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Device: test of sensors for somnonaute device; Device: test of sensors for uronaute device; Device: test of sensors for toconaute device; Device: test of sensors for cardioskin device; Device: test of sensors for neuronaute device

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75646
    • Institut du Cerveau et de la Moelle Epinière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• women or men >18 years
• affiliation to a social security system

Exclusion Criteria:

• Wounds or wounds on the body and the scalp;
• Refusal of consent, minor
• Not membership to the Social Security
• Participant not capable of following the procedure of use (according to the judgment of the investigator);
• Brain surgery that took place less than a week ago
• Allergy known about the money, the polyamide, the silicone, the synthetic materials;
• Sensory Disorders(Confusions) returning the insensible subject to the pain;
• Motor or mental disorders preventing the subject from expressing his pain;
• Behavioral problems that make the subject excessively agitated or aggressive;
• People with cardio-respiratory problems likely to be aggravated by the slight compression of the thorax;
• Subject equipped with an electrical stimulation device;
• Unsuitable anthropometric Parameters (for the women, the sizes superior to 24 will be excluded and for the men(people) those superior to 34);
• Pregnancy clinically detectable or known for the subject;
• Current(in class) Participation in a clinical trial or participation in a previous clinical trial understanding(including) a period of not past(over) deficiency at the time of this clinical trial.
• Predisposition in the headaches of tension (the compression exercised by the hat(cap) can activate(start) in certain cases a headache);
• Use of the device(plan) within the framework of a resuscitation or of intensive care;
• Participating carrier of a defibrillator, a stimulating of the vagus nerve, or quite different surgical high-frequency device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test of sensors for somnonaute device; monitoring with sensors	Device: test of sensors for somnonaute device; test of sensors
Experimental: test of sensors for uronaute device; monitoring with sensors	Device: test of sensors for uronaute device; test of sensors
Experimental: test of sensors for toconaute device; monitoring with sensors	Device: test of sensors for toconaute device; test of sensors
Experimental: test of sensors for cardioskin device; monitoring with sensors	Device: test of sensors for cardioskin device; test of sensors
Experimental: test of sensors for neuronaute device; monitoring with sensors	Device: test of sensors for neuronaute device; test of sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor quality validation	Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns : eg amplitude of signal, regularity..	24 months

Collaborators and Investigators

• Sponsor: BioSerenity
• Investigators: Study Director: quang TRAN, BioSerenity

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017-A02535-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No