<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/NCT03831802</url>
  </required_header>
  <id_info>
    <org_study_id>EMBQL</org_study_id>
    <nct_id>NCT03831802</nct_id>
  </id_info>
  <brief_title>Embrace and Quality of Life</brief_title>
  <acronym>EMBQL</acronym>
  <official_title>Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of&#xD;
      life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides&#xD;
      measures of electrodermal activity and accelerometry. These measures are used to&#xD;
      automatically detect epileptic seizures that are transmitted to a mobile phone-based system&#xD;
      for alerts and recording.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    because of technical issues&#xD;
  </why_stopped>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Actual">August 20, 2021</completion_date>
  <primary_completion_date type="Actual">October 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31</measure>
    <time_frame>3 month</time_frame>
    <description>The change between the QOLIE-31 questionnaire total score measured at the first and the final visit will serve as primary endpoint. The possible range of each scale's final score is from 0 to 100. higher scores reflect better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mean change from Baseline of the total scores of seven Quality of Life in Epilepsy Inventory-31 subscales covering the following epilepsy-specific domains:</measure>
    <time_frame>3 month</time_frame>
    <description>Epilepsy-specific domains are: seizure worry, overall QOL, emotional well being, energy/fatigue subscales, medication effects, work-driving-social limits, cognitive function subscales. The possible range of each scale's final score is from 0 to 100. Higher scores reflect better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of true and false positives seizure detection</measure>
    <time_frame>3 month</time_frame>
    <description>Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The usability total score of Embrace and Mate apps</measure>
    <time_frame>3 month</time_frame>
    <description>Will be assessed with the System usability scale (SUS). The score are to 0 from 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The utility total score of the system in general</measure>
    <time_frame>3 month</time_frame>
    <description>will be assessed via a structured questionnaire-based interview that was Tailored for this study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Epilepsy, Tonic-Clonic</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will make use of the Alert app that sends alarms to patients mobile devices, and if desired to the mobile devices of their caregivers. This group will also use the Mate app which is used as a seizure diary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will only use the Mate app and not the Alert app. This group will thus not receive any notification, from the device, and will be unaware, of the devices performance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embrace with Alert and Mate apps</intervention_name>
    <description>Patients will wear the device on their wrist as often as possible during the day and night. The Embrace Watch contains sensors and memory recordings of electrodermal activity, temperature and physical activity from the wearer. This group will receive notifications on the mobile phone when seizure takes place. Quality of life questionnaires will be filled by the patients at the first follow-up and final assessments.</description>
    <arm_group_label>experimental group</arm_group_label>
    <other_name>experimental group's intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embrace with Mate app only</intervention_name>
    <description>Patients will wear the device on their wrist as often as possible during the day and night. This group will just use the Mate app that summarizes Embrace Watch data for the owner and captures contextual information around events.This group will not receive any alert notification on the mobile phone when a seizure takes place.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Control group's intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female aged &gt;18 years old&#xD;
&#xD;
          -  clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure&#xD;
&#xD;
          -  primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic&#xD;
             convulsion&#xD;
&#xD;
          -  seizure frequency &gt; 1 seizure/month during the last three months&#xD;
&#xD;
          -  signed the informed consent form&#xD;
&#xD;
          -  own a mobile phone device compatible with the embrace apps&#xD;
&#xD;
          -  able to use the device without help from caregivers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients aged less than 18 years old&#xD;
&#xD;
          -  epilepsy diagnosis remains uncertain&#xD;
&#xD;
          -  evidence of psychogenic non epileptic seizures&#xD;
&#xD;
          -  seizure frequency below 1/month during any of the three previous months&#xD;
&#xD;
          -  past-history of nickel allergy and contact dermatitis&#xD;
&#xD;
          -  did not sign the informed consent form&#xD;
&#xD;
          -  does not own mobile phone device compatible with the embrace apps&#xD;
&#xD;
          -  cognitive or behavioral impairment preventing compliance or correct use of the device&#xD;
             and app.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Neurotech</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Philippe Ryvlin</investigator_full_name>
    <investigator_title>Head of Department of Clinical Neurosciences</investigator_title>
  </responsible_party>
  <keyword>epilepsy</keyword>
  <keyword>mhealth</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Epilepsy, Generalized</mesh_term>
    <mesh_term>Epilepsy, Tonic-Clonic</mesh_term>
  </condition_browse>
  <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/NCT03831802
org study id: EMBQL
nct id: NCT03831802
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of
      life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides
      measures of electrodermal activity and accelerometry. These measures are used to
      automatically detect epileptic seizures that are transmitted to a mobile phone-based system
      for alerts and recording.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
time frame: 3 month
description: The change between the QOLIE-31 questionnaire total score measured at the first and the final visit will serve as primary endpoint. The possible range of each scale's final score is from 0 to 100. higher scores reflect better quality of life.
measure: The mean change from Baseline of the total scores of seven Quality of Life in Epilepsy Inventory-31 subscales covering the following epilepsy-specific domains:
time frame: 3 month
description: Epilepsy-specific domains are: seizure worry, overall QOL, emotional well being, energy/fatigue subscales, medication effects, work-driving-social limits, cognitive function subscales. The possible range of each scale's final score is from 0 to 100. Higher scores reflect better quality of life.
measure: Total number of true and false positives seizure detection
time frame: 3 month
description: Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app
measure: The usability total score of Embrace and Mate apps
time frame: 3 month
description: Will be assessed with the System usability scale (SUS). The score are to 0 from 100.
measure: The utility total score of the system in general
time frame: 3 month
description: will be assessed via a structured questionnaire-based interview that was Tailored for this study
arm group label: experimental group
arm group type: Experimental
description: The experimental group will make use of the Alert app that sends alarms to patients mobile devices, and if desired to the mobile devices of their caregivers. This group will also use the Mate app which is used as a seizure diary
arm group label: Control group
arm group type: Active Comparator
description: The control group will only use the Mate app and not the Alert app. This group will thus not receive any notification, from the device, and will be unaware, of the devices performance
intervention type: Device
intervention name: Embrace with Alert and Mate apps
description: Patients will wear the device on their wrist as often as possible during the day and night. The Embrace Watch contains sensors and memory recordings of electrodermal activity, temperature and physical activity from the wearer. This group will receive notifications on the mobile phone when seizure takes place. Quality of life questionnaires will be filled by the patients at the first follow-up and final assessments.
arm group label: experimental group
other name: experimental group's intervention
intervention type: Device
intervention name: Embrace with Mate app only
description: Patients will wear the device on their wrist as often as possible during the day and night. This group will just use the Mate app that summarizes Embrace Watch data for the owner and captures contextual information around events.This group will not receive any alert notification on the mobile phone when a seizure takes place.
arm group label: Control group
other name: Control group's intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Philippe Ryvlin
investigator title: Head of Department of Clinical Neurosciences
mesh term: Epilepsy
mesh term: Epilepsy, Generalized
mesh term: Epilepsy, Tonic-Clonic
sharing ipd: No