<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/NCT04418544</url>
  </required_header>
  <id_info>
    <org_study_id>002 Soniphi</org_study_id>
    <nct_id>NCT04418544</nct_id>
  </id_info>
  <brief_title>Vocal Feature Analysis Algorithm for COVID-19 Detection</brief_title>
  <official_title>Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soniphi LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UserWise, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Soniphi LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational, prospective, non-randomized, non-significant risk study collecting&#xD;
      voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of&#xD;
      specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices&#xD;
      through an app on their mobile phone. Patients and health care providers will be blinded to&#xD;
      the swab test results during Phase 2 of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this observational study is to determine if the Vocal Feature&#xD;
      Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from&#xD;
      voice recordings. Patients eligible for the study are those being tested for COVID-19 based&#xD;
      on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab.&#xD;
&#xD;
      No clinical decisions will be based on the recordings. The results of the algorithm analysis&#xD;
      will not be made available to the subjects or their healthcare providers during or after the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and Specificity</measure>
    <time_frame>6 months</time_frame>
    <description>compare Sensitivity and Specificity to standard swab test</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Do not test positive for COVID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 Positive</arm_group_label>
    <description>Test positive for Covid using swab test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device used to record voice for screening</intervention_name>
    <description>voice recording</description>
    <arm_group_label>COVID-19 Positive</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients being tested for COVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, aged &gt; 18 years&#xD;
&#xD;
          2. Provide a valid electronic informed consent form&#xD;
&#xD;
          3. Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and&#xD;
             those providing an evaluable sample.&#xD;
&#xD;
          4. Stated willingness to provide evidence of their lab test results&#xD;
&#xD;
          5. Pregnant or lactating women may participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of tracheostomy or past tracheostomy with permanent change to the voice due&#xD;
             complications that involved the vocal cords.&#xD;
&#xD;
          2. Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or&#xD;
             esophageal surgery&#xD;
&#xD;
          3. Prior head, neck or throat cancer treated with radical neck dissection and/or&#xD;
             radiation therapy that may influence the vocal cords&#xD;
&#xD;
          4. Treatment with another investigational drug or device within 30 days prior to signing&#xD;
             Consent Form&#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>Stephen Steady, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soniphi LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen Steady, MD</last_name>
    <phone>(415) 309-3242</phone>
    <email>slsteady@vivacitashealthcare.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ari Levitt, MD</last_name>
    <phone>(206) 731-9172</phone>
    <email>aril@sonaphi.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Soniphi</name>
      <address>
        <city>Sebastopol</city>
        <state>California</state>
        <zip>95472</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M Sanderson, BS</last_name>
      <email>research@soniphi.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</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>COVID-19</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/NCT04418544
org study id: 002 Soniphi
nct id: NCT04418544
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is an observational, prospective, non-randomized, non-significant risk study collecting
      voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of
      specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices
      through an app on their mobile phone. Patients and health care providers will be blinded to
      the swab test results during Phase 2 of the study.
The primary objective of this observational study is to determine if the Vocal Feature
      Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from
      voice recordings. Patients eligible for the study are those being tested for COVID-19 based
      on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab.

      No clinical decisions will be based on the recordings. The results of the algorithm analysis
      will not be made available to the subjects or their healthcare providers during or after the
      study.
observational model: Cohort
time perspective: Cross-Sectional
measure: Sensitivity and Specificity
time frame: 6 months
description: compare Sensitivity and Specificity to standard swab test
arm group label: Control
description: Do not test positive for COVID
arm group label: COVID-19 Positive
description: Test positive for Covid using swab test.
intervention type: Device
intervention name: Device used to record voice for screening
description: voice recording
arm group label: COVID-19 Positive
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Steady, MD
role: Principal Investigator
affiliation: Soniphi LLC
last name: Stephen Steady, MD
phone: (415) 309-3242
email: slsteady@vivacitashealthcare.com
last name: Ari Levitt, MD
phone: (206) 731-9172
email: aril@sonaphi.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19