<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805243</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A02535-48</org_study_id>
    <nct_id>NCT03805243</nct_id>
  </id_info>
  <brief_title>Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles</brief_title>
  <acronym>DATASET</acronym>
  <official_title>Evaluation of the Signals électrophysiologiques Measured by Intelligent Textiles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioSerenity</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioSerenity</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BioSerenity suggests developing innovative solutions, from intelligent clothes which can be&#xD;
      used in a hospital environment or at home. These textiles allow, in particular, to measure&#xD;
      the biophysiological signals while letting to the participant the freedom pursue its daily&#xD;
      activities.&#xD;
&#xD;
      BioSerenity has already developed two wearable wireless and portable medical devices:&#xD;
      cardioskin with textile ECG electrods , and the Neuronaute with textile EEG, EMG electrods.&#xD;
&#xD;
      The aim of the study is to test these sensors to optimize their signal to integrate them in&#xD;
      future Bioserenity devices like a somnonaute to help diagnosis of sleep disorders, like&#xD;
      uronaute to help diagnosis of urination disorders, like toconaute to help monitoring of&#xD;
      pregnancy. Others CE-marked sensors developed by others manufacturers will be tested to&#xD;
      choose those that will be integrated in the Bioserenity devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The various alone sensors tested in the clinical trial (sensors of Bioserenity and the other&#xD;
      manufacturers), will supply information which will allow to develop future devices. Some of&#xD;
      these sensors will then be selected to integrate them.&#xD;
&#xD;
      The tests will be made according to the therapeutic area of the concerned device(plan). There&#xD;
      are 5 therapeutic areas:&#xD;
&#xD;
      Cardiovascular (Cardioskin device), neurology ( Neuronaute device), urology ( Uronaute&#xD;
      device), obstetrics ( Toconaute device), somnologie (Somnonaute device).&#xD;
&#xD;
      One subject would likely test either one sensor of a device or multiple sensors, either an&#xD;
      entire device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change of products design&#xD;
  </why_stopped>
  <start_date type="Actual">November 29, 2019</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All subject would likely test each the 5 devices</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensor quality validation</measure>
    <time_frame>24 months</time_frame>
    <description>Signal is considered as of &quot;good quality&quot; &quot; not good quality&quot; regarding criteria of signal patterns : eg amplitude of signal, regularity..</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>test of sensors for somnonaute device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>monitoring with sensors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test of sensors for uronaute device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>monitoring with sensors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test of sensors for toconaute device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>monitoring with sensors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test of sensors for cardioskin device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>monitoring with sensors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test of sensors for neuronaute device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>monitoring with sensors</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>test of sensors for somnonaute device</intervention_name>
    <description>test of sensors</description>
    <arm_group_label>test of sensors for somnonaute device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>test of sensors for uronaute device</intervention_name>
    <description>test of sensors</description>
    <arm_group_label>test of sensors for uronaute device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>test of sensors for toconaute device</intervention_name>
    <description>test of sensors</description>
    <arm_group_label>test of sensors for toconaute device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>test of sensors for neuronaute device</intervention_name>
    <description>test of sensors</description>
    <arm_group_label>test of sensors for neuronaute device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>test of sensors for cardioskin device</intervention_name>
    <description>test of sensors</description>
    <arm_group_label>test of sensors for cardioskin device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women or men &gt;18 years&#xD;
&#xD;
          -  affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wounds or wounds on the body and the scalp;&#xD;
&#xD;
          -  Refusal of consent, minor&#xD;
&#xD;
          -  Not membership to the Social Security&#xD;
&#xD;
          -  Participant not capable of following the procedure of use (according to the judgment&#xD;
             of the investigator);&#xD;
&#xD;
          -  Brain surgery that took place less than a week ago&#xD;
&#xD;
          -  Allergy known about the money, the polyamide, the silicone, the synthetic materials;&#xD;
&#xD;
          -  Sensory Disorders(Confusions) returning the insensible subject to the pain;&#xD;
&#xD;
          -  Motor or mental disorders preventing the subject from expressing his pain;&#xD;
&#xD;
          -  Behavioral problems that make the subject excessively agitated or aggressive;&#xD;
&#xD;
          -  People with cardio-respiratory problems likely to be aggravated by the slight&#xD;
             compression of the thorax;&#xD;
&#xD;
          -  Subject equipped with an electrical stimulation device;&#xD;
&#xD;
          -  Unsuitable anthropometric Parameters (for the women, the sizes superior to 24 will be&#xD;
             excluded and for the men(people) those superior to 34);&#xD;
&#xD;
          -  Pregnancy clinically detectable or known for the subject;&#xD;
&#xD;
          -  Current(in class) Participation in a clinical trial or participation in a previous&#xD;
             clinical trial understanding(including) a period of not past(over) deficiency at the&#xD;
             time of this clinical trial.&#xD;
&#xD;
          -  Predisposition in the headaches of tension (the compression exercised by the hat(cap)&#xD;
             can activate(start) in certain cases a headache);&#xD;
&#xD;
          -  Use of the device(plan) within the framework of a resuscitation or of intensive care;&#xD;
&#xD;
          -  Participating carrier of a defibrillator, a stimulating of the vagus nerve, or quite&#xD;
             different surgical high-frequency device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>quang TRAN</last_name>
    <role>Study Director</role>
    <affiliation>BioSerenity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Du Cerveau Et de La Moelle Epiniere</name>
      <address>
        <city>Paris</city>
        <zip>75646</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>April 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805243
org study id: 2017-A02535-48
nct id: NCT03805243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: All subject would likely test each the 5 devices
primary purpose: Other
masking: None (Open Label)
measure: Sensor quality validation
time frame: 24 months
description: Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns : eg amplitude of signal, regularity..
arm group label: test of sensors for somnonaute device
arm group type: Experimental
description: monitoring with sensors
arm group label: test of sensors for uronaute device
arm group type: Experimental
description: monitoring with sensors
arm group label: test of sensors for toconaute device
arm group type: Experimental
description: monitoring with sensors
arm group label: test of sensors for cardioskin device
arm group type: Experimental
description: monitoring with sensors
arm group label: test of sensors for neuronaute device
arm group type: Experimental
description: monitoring with sensors
intervention type: Device
intervention name: test of sensors for somnonaute device
description: test of sensors
arm group label: test of sensors for somnonaute device
intervention type: Device
intervention name: test of sensors for uronaute device
description: test of sensors
arm group label: test of sensors for uronaute device
intervention type: Device
intervention name: test of sensors for toconaute device
description: test of sensors
arm group label: test of sensors for toconaute device
intervention type: Device
intervention name: test of sensors for neuronaute device
description: test of sensors
arm group label: test of sensors for neuronaute device
intervention type: Device
intervention name: test of sensors for cardioskin device
description: test of sensors
arm group label: test of sensors for cardioskin device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: quang TRAN
role: Study Director
affiliation: BioSerenity
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No