CClinicalTrials.gg
TerminatedNCT03805243DATASETUpdated Nov 11, 2021

Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles

An interventional study of test of sensors for somnonaute device and test of sensors for uronaute device in Healthy, sponsored by BioSerenity. Terminated at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-11.

Sponsored by BioSerenity · Not applicable, Interventional, and Other

Why this study was terminated
Change of products design
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 biophysiological signals while letting to the participant the freedom pursue its daily activities.

BioSerenity has already developed two wearable wireless and portable medical devices: cardioskin with textile ECG electrods , and the Neuronaute with textile EEG, EMG electrods.

The aim of the study is to test these sensors to optimize their signal to integrate them in future Bioserenity devices like a somnonaute to help diagnosis of sleep disorders, like uronaute to help diagnosis of urination disorders, like toconaute to help monitoring of pregnancy. Others CE-marked sensors developed by others manufacturers will be tested to choose those that will be integrated in the Bioserenity devices.

Read the 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 will then be selected to integrate them.

The tests will be made according to the therapeutic area of the concerned device(plan). There are 5 therapeutic areas:

Cardiovascular (Cardioskin device), neurology ( Neuronaute device), urology ( Uronaute device), obstetrics ( Toconaute device), somnologie (Somnonaute device).

One subject would likely test either one sensor of a device or multiple sensors, either an entire device.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    test of sensors for somnonaute device

    monitoring with sensors

    Device: test of sensors for somnonaute device

  • Experimental
    test of sensors for uronaute device

    monitoring with sensors

    Device: test of sensors for uronaute device

  • Experimental
    test of sensors for toconaute device

    monitoring with sensors

    Device: test of sensors for toconaute device

  • Experimental
    test of sensors for cardioskin device

    monitoring with sensors

    Device: test of sensors for cardioskin device

  • Experimental
    test of sensors for neuronaute device

    monitoring with sensors

    Device: test of sensors for neuronaute device

Interventions

  • Devicetest of sensors for somnonaute device

    test of sensors

  • Devicetest of sensors for uronaute device

    test of sensors

  • Devicetest of sensors for toconaute device

    test of sensors

  • Devicetest of sensors for neuronaute device

    test of sensors

  • Devicetest of sensors for cardioskin device

    test of sensors

05

What researchers measure

Primary outcomes

  1. Sensor quality validation

    Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns : eg amplitude of signal, regularity..

    Time frame: 24 months

06

Study locations

1 site
  • Institut Du Cerveau Et de La Moelle Epiniere
    Paris, 75646, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03805243
Lead sponsor
BioSerenity
Responsible party
Sponsor
First posted
Jan 15, 2019
Start date
Nov 29, 2019
Primary completion
Dec 21, 2020
Completion
Dec 21, 2020
Last update
Nov 11, 2021

Study contacts

quang TRAN
study director · BioSerenity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion