Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked

NCT03725462 | Completed

• 1 other identifier: 2017-A00648-45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Sensor quality validation

  Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..)

  2 month

Study Arms (2)

Cardioskin

EXPERIMENTAL

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.

Device: Cardioskin

Neuronaute

EXPERIMENTAL

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.

Device: Neuronaute

Interventions

Cardioskin DEVICE

Subjects have a monitoring with cardioskin and comparator

Cardioskin

Neuronaute DEVICE

Subjects have a monitoring with Neuronaute and comparator

Neuronaute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• man or women of at least 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• BioSerenity: lead

Study Sites (1)

ICM

Paris, 75013, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 31, 2018
• Study Start: October 16, 2017
• Primary Completion: March 2, 2019
• Study Completion: April 16, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-02

Locations

FR (1)