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OpenTrials
Completed

NCT Number: NCT03725462

Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked

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.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICM

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioskin

Device

Subjects have a monitoring with cardioskin and comparator

Neuronaute

Device

Subjects have a monitoring with Neuronaute and comparator

Primary outcomes

  1. Sensor quality validation

    Time frame: 2 month

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

Sponsors and collaborators

Lead sponsor

BioSerenity

Industry

Registry information

Acronym: STREAM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.