Clinical trial NCT03805243: Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles
Official title: Evaluation of the Signals électrophysiologiques Measured by Intelligent Textiles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All subject would likely test each the 5 devices
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensor quality validation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Du Cerveau Et de La Moelle Epiniere
Study officials:
affiliation: BioSerenity
name: quang TRAN
role: STUDY_DIRECTOR
References: