<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/NCT04404036</url>
  </required_header>
  <id_info>
    <org_study_id>PRO#00097842</org_study_id>
    <nct_id>NCT04404036</nct_id>
  </id_info>
  <brief_title>Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure</brief_title>
  <official_title>Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure</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 eustachian tube dysfunction (ETD) or facial pain/pressure.&#xD;
      SinuSonic is a medical device that utilizes sound and pressure combined with normal&#xD;
      breathing. The study will have 3 aims. Aim 1 will examine healthy controls with no signs of&#xD;
      upper respiratory infection, inflammation, or ETD to determine if exhaled nasal Nitric Oxide&#xD;
      is increased. Nitric Oxide is a compound in the body that acts as a blood vessel relaxant.&#xD;
      Acoustic energy (humming) has been shown to increase nasal Nitric Oxide dramatically, thus&#xD;
      equalization of gas pressures between the middle ear, the paranasal sinuses and the nasal&#xD;
      cavity may very well explain any efficacy noted. Aim 2 will be performed to examine&#xD;
      therapeutic efficacy for ETD. Aim 3 will be performed to examine therapeutic efficacy for&#xD;
      sinus pain/pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms severity according to an ETD Visual Analogue Scale</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms severity according to a Pain/pressure Visual Analogue Scale</measure>
    <time_frame>2 to 4 Weeks</time_frame>
    <description>Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>McGill Pain Questionnaire - Short Form</measure>
    <time_frame>2 to 4 Weeks</time_frame>
    <description>The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)</measure>
    <time_frame>2 to 4 Weeks</time_frame>
    <description>Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Overall ETDQ-7 Score</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Mean change from baseline to 6 weeks in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that the participant's ears are clogged or underwater, ear symptoms when the participants have a cold or sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that the participant's hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Eustachian Tube Dysfunction</condition>
  <condition>Facial Pain</condition>
  <arm_group>
    <arm_group_label>SinuSonic Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aim 1: SinuSonic device used once a day over a 2 day period.&#xD;
Aim 2: SinuSonic device used twice daily for 3 minutes in the home setting for 6 weeks.&#xD;
Aim 3: SinuSonic device used twice daily for 3 minutes in the home setting for 4 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>
  <eligibility>
    <criteria>
      <textblock>
        AIM 1&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sinonasal or ear surgery within last 3 months (including balloon ET dilation)&#xD;
&#xD;
          -  Any ENT condition that may impact upper airway to include sinusitis, otitis, or&#xD;
             allergies&#xD;
&#xD;
          -  Upper respiratory illness within last 2 weeks&#xD;
&#xD;
          -  Topical decongestant use in last week&#xD;
&#xD;
          -  Current nasal crusting or ulceration on rhinoscopy&#xD;
&#xD;
          -  History of severe nose bleeding within last 3 months&#xD;
&#xD;
          -  Known pregnancy&#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;
&#xD;
        AIM 2&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          -  Adults 18 years or older with diagnosis of ETD by an otolaryngologist&#xD;
&#xD;
          -  ≥6 months of symptoms duration&#xD;
&#xD;
          -  ≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of&#xD;
             ears, muffled hearing, tinnitus)&#xD;
&#xD;
          -  ETDQ-7 score ≥ 3&#xD;
&#xD;
          -  Audiogram within the last year&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Sinonasal or ear surgery within last 3 months (including balloon ET dilation)&#xD;
&#xD;
          -  Indwelling ear tubes&#xD;
&#xD;
          -  Tympanic membrane perforation&#xD;
&#xD;
          -  Hx of cholesteatoma, mastoidectomy, tympanoplasty, or ossicular chain reconstruction&#xD;
&#xD;
          -  Patulous ET&#xD;
&#xD;
          -  Hx of Meniere's disease&#xD;
&#xD;
          -  Moderate or severe nasal valve collapse&#xD;
&#xD;
          -  Grade 3-4 polyps&#xD;
&#xD;
          -  Upper respiratory illness within last 2 weeks&#xD;
&#xD;
          -  Topical decongestant use in last week&#xD;
&#xD;
          -  Current nasal crusting or ulceration on rhinoscopy&#xD;
&#xD;
          -  History of severe nose bleeding within last 3 months&#xD;
&#xD;
          -  Known pregnancy&#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;
&#xD;
        AIM 3&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          -  Adults 18 years or older who complain of facial pain or pressure&#xD;
&#xD;
          -  ≥3 months of symptoms duration (can be intermittent)&#xD;
&#xD;
          -  Pain/pressure VAS score ≥ 5&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Sinonasal surgery within the last 3 months&#xD;
&#xD;
          -  Grade 3-4 polyps&#xD;
&#xD;
          -  Upper respiratory illness within last 2 weeks&#xD;
&#xD;
          -  Topical decongestant use in last week&#xD;
&#xD;
          -  Current nasal crusting or ulceration on rhinoscopy&#xD;
&#xD;
          -  History of severe nose bleeding within last 3 months&#xD;
&#xD;
          -  Known pregnancy&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthew Germroth</last_name>
    <phone>8438761166</phone>
    <email>germroth@musc.edu</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas C Lackland</last_name>
    </contact>
    <investigator>
      <last_name>Theodore McRackan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</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>Facies</mesh_term>
    <mesh_term>Facial Pain</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>
  <!-- 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/NCT04404036
org study id: PRO#00097842
nct id: NCT04404036
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 eustachian tube dysfunction (ETD) or facial pain/pressure.
      SinuSonic is a medical device that utilizes sound and pressure combined with normal
      breathing. The study will have 3 aims. Aim 1 will examine healthy controls with no signs of
      upper respiratory infection, inflammation, or ETD to determine if exhaled nasal Nitric Oxide
      is increased. Nitric Oxide is a compound in the body that acts as a blood vessel relaxant.
      Acoustic energy (humming) has been shown to increase nasal Nitric Oxide dramatically, thus
      equalization of gas pressures between the middle ear, the paranasal sinuses and the nasal
      cavity may very well explain any efficacy noted. Aim 2 will be performed to examine
      therapeutic efficacy for ETD. Aim 3 will be performed to examine therapeutic efficacy for
      sinus pain/pressure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Symptoms severity according to an ETD Visual Analogue Scale
time frame: 6 Weeks
description: Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
measure: Symptoms severity according to a Pain/pressure Visual Analogue Scale
time frame: 2 to 4 Weeks
description: Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
measure: McGill Pain Questionnaire - Short Form
time frame: 2 to 4 Weeks
description: The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).
measure: Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
time frame: 2 to 4 Weeks
description: Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).
measure: Mean Change in Overall ETDQ-7 Score
time frame: 6 Weeks
description: Mean change from baseline to 6 weeks in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that the participant's ears are clogged or underwater, ear symptoms when the participants have a cold or sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that the participant's hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.
arm group label: SinuSonic Device
arm group type: Experimental
description: Aim 1: SinuSonic device used once a day over a 2 day period.
Aim 2: SinuSonic device used twice daily for 3 minutes in the home setting for 6 weeks.
Aim 3: SinuSonic device used twice daily for 3 minutes in the home setting for 4 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
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Germroth
phone: 8438761166
email: germroth@musc.edu
facility: 
status: Recruiting
contact: 
investigator: 
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: Facies
mesh term: Facial Pain
sharing ipd: No
ipd description: Not Applicable. The investigators plan to publish this study.