Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked (STREAM)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Cardioskin; Device: Neuronaute

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • ICM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Cardioskin; Subjects have a monitoring with cardioskin and comparator
Experimental: 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.	Device: Neuronaute; Subjects have a monitoring with Neuronaute and comparator

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.beat detection, beats variability..)	2 month

Collaborators and Investigators

• Sponsor: BioSerenity

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): March 2, 2019
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017-A00648-45

Drug and device information, study documents

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