<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/NCT04505852</url>
  </required_header>
  <id_info>
    <org_study_id>CF19347A</org_study_id>
    <nct_id>NCT04505852</nct_id>
  </id_info>
  <brief_title>Implementing Artificial-intelligence Wristbands to Help in Recording Seizures</brief_title>
  <official_title>Implementing Artificial-intelligence Wristbands to Help in Recording Seizures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that the participants will be satisfied with&#xD;
      artificial-intelligence wristband Embrace&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, seizure tracking relies on subjective patient and family recall. In several&#xD;
      studies patients report only approximately half of their seizures, and even less during&#xD;
      sleep.&#xD;
&#xD;
      Sudden unexplained death in epilepsy (SUDEP) is the cause of premature death of up to 17% of&#xD;
      all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as&#xD;
      high as 1% per year). Its etiology is probably due to peri-ictal respiratory, cardiac, or&#xD;
      autonomic nervous system dysfunction.&#xD;
&#xD;
      Wristband sensors help caregivers assist patients during seizures and may reduce risks for&#xD;
      complications such as injuries and SUDEP.&#xD;
&#xD;
      Accurate seizure detection may improve the quality of life (QoL) of subjects and caregivers&#xD;
      by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the&#xD;
      home setting. Possible risks are occurrence of alarm fatigue and invasion of privacy.&#xD;
&#xD;
      The wristband Embrace has an overall sensitivity of 89.1% and an overall specificity of&#xD;
      93.1%. The investigators hypothesize that the participants will be satisfied with&#xD;
      artificial-intelligence wristband Embrace.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      When the smart wristband detects the seizure, the mobile phone sends a text message to the&#xD;
      companion and the nurse, the latter will see or get in touch with the companion and keep a&#xD;
      record.&#xD;
&#xD;
      In-patients receiving video-electroencephalography (VEEG) exam use Embrace during the VEEG&#xD;
      recording which usually takes 3-5 days.&#xD;
&#xD;
      Out-patients use Embrace for 8 weeks. The investigators will enroll 30-50 patients, half&#xD;
      in-patients and half out-patients.&#xD;
&#xD;
      The benefits are evaluated in terms of satisfaction. .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 5, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction score of seizure wristband</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Scores 1(least satisfied) to 10 (most satisfied)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>EMBRACE USERS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Embrace wristband users</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embrace</intervention_name>
    <description>Patients wear Embrace2 to help in seizure reporting and patient care.</description>
    <arm_group_label>EMBRACE USERS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one seizure per month in the 3-month period before entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or&#xD;
             lung disorder, rapid progressive brain disorder, life-terminal disease, severe&#xD;
             infection/ bleeding/ liver/ kidney disorder, platelet &lt;80,000/μL, neutrophil&#xD;
             &lt;1,000/μL, clinically significant ECG abnormality, unstable psychiatric disease&#xD;
             (except anxiety).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PEIYUAN F. HSIEH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PEIYUAN F. HSIEH, MD</last_name>
    <phone>886-4-23592525</phone>
    <phone_ext>3021</phone_ext>
    <email>pfhsieh@vghtc.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taichung Veterans General Hospital</investigator_affiliation>
    <investigator_full_name>PEIYUAN F. HSIEH</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</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/NCT04505852
org study id: CF19347A
nct id: NCT04505852
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators hypothesize that the participants will be satisfied with
      artificial-intelligence wristband Embrace
Currently, seizure tracking relies on subjective patient and family recall. In several
      studies patients report only approximately half of their seizures, and even less during
      sleep.

      Sudden unexplained death in epilepsy (SUDEP) is the cause of premature death of up to 17% of
      all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as
      high as 1% per year). Its etiology is probably due to peri-ictal respiratory, cardiac, or
      autonomic nervous system dysfunction.

      Wristband sensors help caregivers assist patients during seizures and may reduce risks for
      complications such as injuries and SUDEP.

      Accurate seizure detection may improve the quality of life (QoL) of subjects and caregivers
      by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the
      home setting. Possible risks are occurrence of alarm fatigue and invasion of privacy.

      The wristband Embrace has an overall sensitivity of 89.1% and an overall specificity of
      93.1%. The investigators hypothesize that the participants will be satisfied with
      artificial-intelligence wristband Embrace.

      Methods:

      When the smart wristband detects the seizure, the mobile phone sends a text message to the
      companion and the nurse, the latter will see or get in touch with the companion and keep a
      record.

      In-patients receiving video-electroencephalography (VEEG) exam use Embrace during the VEEG
      recording which usually takes 3-5 days.

      Out-patients use Embrace for 8 weeks. The investigators will enroll 30-50 patients, half
      in-patients and half out-patients.

      The benefits are evaluated in terms of satisfaction. .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Satisfaction score of seizure wristband
time frame: Through study completion, an average of 1 year
description: Scores 1(least satisfied) to 10 (most satisfied)
arm group label: EMBRACE USERS
arm group type: Experimental
description: Embrace wristband users
intervention type: Device
intervention name: Embrace
description: Patients wear Embrace2 to help in seizure reporting and patient care.
arm group label: EMBRACE USERS
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: PEIYUAN F. HSIEH, MD
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
last name: PEIYUAN F. HSIEH, MD
phone: 886-4-23592525
phone ext: 3021
email: pfhsieh@vghtc.gov.tw
facility: 
status: Recruiting
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taichung Veterans General Hospital
investigator full name: PEIYUAN F. HSIEH
investigator title: Principal Investigator
mesh term: Seizures
sharing ipd: No