Status:

TERMINATED

Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles

Lead Sponsor:

BioSerenity

Conditions:

Healthy

Eligibility:

All Genders

18+ years

Phase:

NA

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 biophysiologi...

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 w...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

November 29 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 21 2020

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT03805243

Start Date

November 29 2019

End Date

December 21 2020

Last Update

November 11 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Institut Du Cerveau Et de La Moelle Epiniere

Paris, France, 75646