<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/NCT04415294</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004521</org_study_id>
    <secondary_id>R21DK117431</secondary_id>
    <nct_id>NCT04415294</nct_id>
  </id_info>
  <brief_title>Flicker App for Minimal Hepatic Encephalopathy</brief_title>
  <official_title>Evaluating a Novel, Self-administered Device (&quot;Flicker-App&quot;) That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      There is a great unmet clinical need for improved screening for MHE in patients with&#xD;
      cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home&#xD;
      by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize&#xD;
      the protocol, software, and hardware of the Flicker-App to create a product appropriate for&#xD;
      production and distribution to patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in&#xD;
      clinic supervised by a research assistant and calculate the level of agreement between the&#xD;
      CFF determined by the Flicker-App, the CFF determined by the &quot;gold-standard&quot; FFS device, and&#xD;
      the test scores on the EncephalApp Stroop test.&#xD;
&#xD;
      SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at&#xD;
      home, including daily measurements over 1 week and weekly measurements over 6 weeks, and&#xD;
      calculate the adherence to this protocol and the variability of these CFF measurements.&#xD;
&#xD;
      SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and&#xD;
      simplify its self-administration by patients based on structured interview-questionnaires&#xD;
      with the study participants and with clinical Gastroenterologists/Hepatologists&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 22, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CFF Agreement</measure>
    <time_frame>1 day</time_frame>
    <description>Level of agreement between Flicker App CFF and gold-standard device</description>
  </primary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Hepatic Encephalopathy</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Critical flicker frequency</intervention_name>
    <description>Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cirrhosis patients without Grade III or IV OHE&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cirrhosis (standard criteria)&#xD;
&#xD;
          -  Chronic liver disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Grade III or IV hepatic encephalopathy&#xD;
&#xD;
          -  Mini-mental state examination score ≤25 (suggestive of dementia)&#xD;
&#xD;
          -  alcohol or illicit drug use within 3 months&#xD;
&#xD;
          -  current use of benzodiazepines&#xD;
&#xD;
          -  antiepileptics or psychotropic drugs&#xD;
&#xD;
          -  color blindness&#xD;
&#xD;
          -  severe vision impairment (blindness, macular degeneration).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George N Ioannou, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Yacoub</last_name>
    <phone>2067443402</phone>
    <email>yacoum@washington.medicine.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Yacoub</last_name>
      <phone>206-744-3402</phone>
      <email>yacoum@medicine.washington.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>George Ioannou</investigator_full_name>
    <investigator_title>Professor, School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatic Encephalopathy</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04415294
org study id: STUDY00004521
secondary id: R21DK117431
nct id: NCT04415294
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a great unmet clinical need for improved screening for MHE in patients with
      cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home
      by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize
      the protocol, software, and hardware of the Flicker-App to create a product appropriate for
      production and distribution to patients
SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in
      clinic supervised by a research assistant and calculate the level of agreement between the
      CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and
      the test scores on the EncephalApp Stroop test.

      SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at
      home, including daily measurements over 1 week and weekly measurements over 6 weeks, and
      calculate the adherence to this protocol and the variability of these CFF measurements.

      SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and
      simplify its self-administration by patients based on structured interview-questionnaires
      with the study participants and with clinical Gastroenterologists/Hepatologists
observational model: Cohort
time perspective: Prospective
measure: CFF Agreement
time frame: 1 day
description: Level of agreement between Flicker App CFF and gold-standard device
intervention type: Diagnostic Test
intervention name: Critical flicker frequency
description: Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: George N Ioannou, MD, MS
role: Principal Investigator
affiliation: University of Washington
last name: Michael Yacoub
phone: 2067443402
email: yacoum@washington.medicine.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: George Ioannou
investigator title: Professor, School of Medicine
mesh term: Hepatic Encephalopathy
mesh term: Brain Diseases