<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/NCT04468204</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100980</org_study_id>
    <nct_id>NCT04468204</nct_id>
  </id_info>
  <brief_title>Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)</brief_title>
  <official_title>Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to test the safety, efficacy and potential mechanism of action of the&#xD;
      SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical&#xD;
      device that utilizes sound and pressure combined with normal breathing. The study will have 2&#xD;
      aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8&#xD;
      week fall URI season. Subjects will use an active device (positive expiratory pressure and&#xD;
      128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8&#xD;
      weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community&#xD;
      acquired viral URIs. Subjects will use active or sham device as above.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Symptoms Score (TSS)</measure>
    <time_frame>60 Days</time_frame>
    <description>The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.&#xD;
The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.&#xD;
The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms)&#xD;
Minimum score=0; maximum score=27.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Upper Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>SinuSonic Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SinuSonic device used for 1 min three times a day for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham SinuSonic device used for 1 min three times a day for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SinuSonic Device</intervention_name>
    <description>A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.</description>
    <arm_group_label>SinuSonic Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham SinuSonic Device</intervention_name>
    <description>Sham positive expiratory pressure intervention using the SinuSonic Device.</description>
    <arm_group_label>Sham</arm_group_label>
    <other_name>Sham</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years or older with no transient symptoms of any URI or allergies at&#xD;
             baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any transient ENT condition that may impact upper airway to include acute sinusitis or&#xD;
             otitis.&#xD;
&#xD;
          -  Any upper respiratory illness within last 2 weeks&#xD;
&#xD;
          -  TSS will be measured at baseline as described above and must be &lt;9 for inclusion&#xD;
             (Eccles etal).&#xD;
&#xD;
          -  Topical decongestant use in last week&#xD;
&#xD;
          -  Current nasal crusting or history of ulceration or perforation&#xD;
&#xD;
          -  History of severe nose bleeding within last 3 months&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Immunosuppressed condition or on immune modulating medications such as prednisone or&#xD;
             chemotherapy&#xD;
&#xD;
          -  Allergic sensitivity to silicone or any other component of device&#xD;
&#xD;
          -  Inability to read and understand English&#xD;
&#xD;
          -  Inability to perform treatment due to underlying medical condition&#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>Sinus Center - Medical Univesity of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <results_first_submitted>September 23, 2022</results_first_submitted>
  <results_first_submitted_qc>November 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2022</results_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Shaun A. Nguyen, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not Applicable. The investigators plan to publish this study.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04468204/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SinuSonic Device</title>
          <description>SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.</description>
        </group>
        <group group_id="P2">
          <title>Sham</title>
          <description>Sham SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SinuSonic Device</title>
          <description>SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.</description>
        </group>
        <group group_id="B2">
          <title>Sham</title>
          <description>Sham SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.2" lower_limit="20" upper_limit="69"/>
                    <measurement group_id="B2" value="48.5" lower_limit="39" upper_limit="69"/>
                    <measurement group_id="B3" value="46.8" lower_limit="20" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Symptoms Score (TSS)</title>
        <description>The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.&#xD;
The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.&#xD;
The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms)&#xD;
Minimum score=0; maximum score=27.</description>
        <time_frame>60 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SinuSonic Device</title>
            <description>SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Symptoms Score (TSS)</title>
          <description>The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.&#xD;
The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.&#xD;
The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms)&#xD;
Minimum score=0; maximum score=27.</description>
          <units>scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.503" spread="0.501"/>
                    <measurement group_id="O2" value="0.843" spread="0.569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SinuSonic Device</title>
          <description>SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.</description>
        </group>
        <group group_id="E2">
          <title>Sham</title>
          <description>Sham SinuSonic device used for 1 min three times a day for 8 weeks.&#xD;
Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Clinical Research</name_or_title>
      <organization>Department of Otolaryngology - Head and Neck Surgery</organization>
      <phone>(843)792-1356</phone>
      <email>nguyensh@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04468204
org study id: Pro00100980
nct id: NCT04468204
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study aims to test the safety, efficacy and potential mechanism of action of the
      SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical
      device that utilizes sound and pressure combined with normal breathing. The study will have 2
      aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8
      week fall URI season. Subjects will use an active device (positive expiratory pressure and
      128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8
      weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community
      acquired viral URIs. Subjects will use active or sham device as above.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total Symptoms Score (TSS)
time frame: 60 Days
description: The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.
The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.
The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms)
Minimum score=0; maximum score=27.
arm group label: SinuSonic Device
arm group type: Experimental
description: SinuSonic device used for 1 min three times a day for 8 weeks.
arm group label: Sham
arm group type: Sham Comparator
description: Sham SinuSonic device used for 1 min three times a day for 8 weeks.
intervention type: Device
intervention name: SinuSonic Device
description: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
arm group label: SinuSonic Device
intervention type: Device
intervention name: Sham SinuSonic Device
description: Sham positive expiratory pressure intervention using the SinuSonic Device.
arm group label: Sham
other name: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Shaun A. Nguyen, MD
investigator title: Professor
mesh term: Infections
mesh term: Respiratory Tract Infections
sharing ipd: No
ipd description: Not Applicable. The investigators plan to publish this study.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 