Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Neuronaute; Device: Cardioskin

• Registration Number: NCT03725462
• Lead Sponsor: BioSerenity

Brief Summary

The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.

It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.

Detailed Description

With this study evulating the performance of two wireless, connected device of electrophysiological signal monitoring. The Cardioskin monitors electrocardiogram signal. The Neuronaute monitors electroencephalogram, electromyogram and electrocardiogram.

This study will permit to optimize the devices performance.

To the study, subjects of at least 18 years old will test Cardioskin and or Neuronaute device, without randomization.

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Status Verified: 2019-02
• Primary Completion: 2019-03-02
• Study Completion: 2019-04-16
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• man or women of at least 18 years old

Exclusion Criteria

• Injuries or wounds on the body and scalp
• Participant unable to follow the procedure of use, the judgment of the investigator
• Brain surgery that occurred less than a week ago
• Known allergy to silver, polyamide, silicone, synthetic materials
• Sensory disorders that make the subject insensitive to pain
• behavioral problems that make the subject excessively agitated or aggressive;
• Cardiorespiratory disorders that may be aggravated by mild compression of thorax
• Subject equipped with an electrical stimulation device;
• Inappropriate anthropometric parameters to textile sizes
• Clinically detectable or known pain of the subject;
• Current participation in a clinical trial or participation in a previous clinical study including a period of deficiency not yet completed at the time of this clinical trial
• Predisposition to tension headaches (the compression exerted by the cap may in some cases trigger a headache);
• Use of the Cardioskin device for resuscitation or intensive care.
• Participant with defibrillator, vagus nerve stimulator or other high frequency surgical device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neuronaute	Neuronaute	Subjects performed a monitoring with Neuronaute. The performance is evaluated either by a comparison with a gold standard, either by a comparison with anterior version of Neuronaute, either by an opinion of an expert.
Cardioskin	Cardioskin	Subjects performed a monitoring with Cardioskin. The performance is evaluated either by a comparison with a gold standard, either by a comparison with anterior version of Cardioskin, either by an opinion of an expert.

Primary Outcome Measures

Name	Time	Method
Sensor quality validation	2 month	Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..)

Trial Locations

Locations (1)

ICM; 🇫🇷 Paris, France