<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/NCT03803098</url>
  </required_header>
  <id_info>
    <org_study_id>NI18035J</org_study_id>
    <nct_id>NCT03803098</nct_id>
  </id_info>
  <brief_title>Evaluation of the Metrological Reliability of Connected Objects in the Measurement of Medical Physiological Parameters</brief_title>
  <acronym>EVALEXPLO</acronym>
  <official_title>Evaluation of the Metrological Reliability of Connected Objects Available to the Public in the Measurement of Medical Physiological Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Many connected objects available over-the-counter to the general public claim to measure&#xD;
      physical quantities that may have a medical application. Examples include heart rate, oxygen&#xD;
      saturation, respiratory rate, blood pressure, body composition between body fat, lean mass&#xD;
      and bone mass, and motion analysis. .&#xD;
&#xD;
      The continuous collection of these quantities by a cheap and easily accessible device opens&#xD;
      important medical perspectives in the areas of home monitoring of chronic diseases or&#xD;
      preventive medicine in general. Nevertheless, the medical decisions that could be made on the&#xD;
      basis of the information provided by these objects require that the measurement be reliable,&#xD;
      which is not always the case.&#xD;
&#xD;
      The evaluation of the accuracy of measurements made by these objects therefore seems to be a&#xD;
      prerequisite for future use in a medical context. This study therefore proposes to test the&#xD;
      adequacy between &quot;gold-standard&quot; measurements carried out in consultation in the department&#xD;
      of functional explorations of the Bichat Claude-Bernard hospital and the measurements of the&#xD;
      same parameters by connected objects, under the conditions of intended uses by their&#xD;
      manufacturer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective : Evaluate, in patients consulting for polysomnography, respiratory&#xD;
      functional explorations or osteodensitometry, or as part of a day hospital cardiology. The&#xD;
      accuracy of the measurement provided by a connected object in relation to the &quot;gold standard&quot;&#xD;
      measurement made during the visit. The parameters studied will be:&#xD;
&#xD;
        -  For polysomnography, pulse oxygen saturation (SpO2), heart rate (HR) and respiratory&#xD;
           rate (RF), sleep quality (efficacy, duration of mild slow sleep, deep slow sleep and REM&#xD;
           sleep)&#xD;
&#xD;
        -  For bone densitometry, body composition in lean mass, fat mass and bone mass, weight •&#xD;
           For respiratory function tests, pulse oxygen saturation (SpO2) and heart rate (HR)&#xD;
&#xD;
        -  For day hospitalization in cardiology, blood pressure (BP), heart rate (HR) and heart&#xD;
           rate, existence of rhythm disorders or conduction&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Evaluate the ease of use of the device (evaluated by an ad-hoc questionnaire completed&#xD;
           by the nursing staff)&#xD;
&#xD;
        -  Describe the temporal evolution of the recorded parameters (excluding osteodensitometry&#xD;
           for which the measurement is unique)&#xD;
&#xD;
        -  For day hospitalization in cardiology, evaluate the diagnostic performance of objects&#xD;
           tested on the existence of cardiac rhythm disorders (sinus bradycardia, sinus&#xD;
           tachycardia, atrial fibrillation, presence of extrasystoles) or conduction disorders&#xD;
           (atrioventricular block). -ventricular, branch block)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Anticipated">August 12, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 12, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>relative error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,</measure>
    <time_frame>the two measures are succesive of the day of the examination</time_frame>
    <description>relative error expressed on a percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>absolute error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,</measure>
    <time_frame>the two measures are succesive of the day of the examination</time_frame>
    <description>absolute error expressed on the unit of the reference measurement</description>
  </secondary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Respiratory; Disorder, Functional, Impaired</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>reference measure</intervention_name>
    <description>measure of a physiological parameter performed with the gold standard medical device</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>alternative measure</intervention_name>
    <description>measure of a physiological parameter performed with the connected device under evaluation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients referred to the physiology department for at least one examination among :&#xD;
        polysomnography, bone densitometry, respiratory functino test, day hospital of cardiology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Patient over 18 years old&#xD;
&#xD;
          -  Patient sent to the functional exploration department of Bichat hospital to perform&#xD;
             one of the following exams: polysomnography, bone densitometry, respiratory function&#xD;
             tests, cardiology day hospital assessment&#xD;
&#xD;
          -  Patient agreement to participate in the study,&#xD;
&#xD;
          -  Affiliated to a social security scheme (benefiting or entitled)&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
        No defined&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justine FRIJA MASSON, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justine FRIJA MASSON, Doctor</last_name>
    <phone>00 33 1 40 25 84 01</phone>
    <email>justine.frija@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Justine Frija</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justine Frija</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Justine Frija</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03803098
org study id: NI18035J
nct id: NCT03803098
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many connected objects available over-the-counter to the general public claim to measure
      physical quantities that may have a medical application. Examples include heart rate, oxygen
      saturation, respiratory rate, blood pressure, body composition between body fat, lean mass
      and bone mass, and motion analysis. .

      The continuous collection of these quantities by a cheap and easily accessible device opens
      important medical perspectives in the areas of home monitoring of chronic diseases or
      preventive medicine in general. Nevertheless, the medical decisions that could be made on the
      basis of the information provided by these objects require that the measurement be reliable,
      which is not always the case.

      The evaluation of the accuracy of measurements made by these objects therefore seems to be a
      prerequisite for future use in a medical context. This study therefore proposes to test the
      adequacy between "gold-standard" measurements carried out in consultation in the department
      of functional explorations of the Bichat Claude-Bernard hospital and the measurements of the
      same parameters by connected objects, under the conditions of intended uses by their
      manufacturer.
Primary objective : Evaluate, in patients consulting for polysomnography, respiratory
      functional explorations or osteodensitometry, or as part of a day hospital cardiology. The
      accuracy of the measurement provided by a connected object in relation to the "gold standard"
      measurement made during the visit. The parameters studied will be:

        -  For polysomnography, pulse oxygen saturation (SpO2), heart rate (HR) and respiratory
           rate (RF), sleep quality (efficacy, duration of mild slow sleep, deep slow sleep and REM
           sleep)

        -  For bone densitometry, body composition in lean mass, fat mass and bone mass, weight •
           For respiratory function tests, pulse oxygen saturation (SpO2) and heart rate (HR)

        -  For day hospitalization in cardiology, blood pressure (BP), heart rate (HR) and heart
           rate, existence of rhythm disorders or conduction

      Secondary objectives:

        -  Evaluate the ease of use of the device (evaluated by an ad-hoc questionnaire completed
           by the nursing staff)

        -  Describe the temporal evolution of the recorded parameters (excluding osteodensitometry
           for which the measurement is unique)

        -  For day hospitalization in cardiology, evaluate the diagnostic performance of objects
           tested on the existence of cardiac rhythm disorders (sinus bradycardia, sinus
           tachycardia, atrial fibrillation, presence of extrasystoles) or conduction disorders
           (atrioventricular block). -ventricular, branch block)
observational model: Other
time perspective: Cross-Sectional
measure: relative error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,
time frame: the two measures are succesive of the day of the examination
description: relative error expressed on a percentage
measure: absolute error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,
time frame: the two measures are succesive of the day of the examination
description: absolute error expressed on the unit of the reference measurement
intervention type: Device
intervention name: reference measure
description: measure of a physiological parameter performed with the gold standard medical device
intervention type: Device
intervention name: alternative measure
description: measure of a physiological parameter performed with the connected device under evaluation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Justine FRIJA MASSON, Doctor
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Justine FRIJA MASSON, Doctor
phone: 00 33 1 40 25 84 01
email: justine.frija@aphp.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Respiration Disorders
sharing ipd: Undecided