xml: <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/NCT06024564</url>
    </required_header>
    <id_info>
      <org_study_id>CP-007</org_study_id>
      <nct_id>NCT06024564</nct_id>
    </id_info>
    <brief_title>Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion</brief_title>
    <official_title>Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Third Wave Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Third Wave Therapeutics</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an interventional study designed to gather data on real world utilization of Acoustic&#xD;
        Resonance Therapy for treating moderate to severe nasal congestion&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>Weekly Utilization-Frequency</measure>
      <time_frame>90 days</time_frame>
      <description>Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly Utilization-Duration</measure>
      <time_frame>90 days</time_frame>
      <description>Weekly utilization of Sonu treatment, measured as the duration of treatment received per week</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total Nasal Symptom Score (TNSS)</measure>
      <time_frame>90 days</time_frame>
      <description>24-hour TNSS; Minimum score=0 (no symptoms), Maximum score=12 (severe symptoms). Lower scores are better and reflect less symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asthma Control</measure>
      <time_frame>90 days</time_frame>
      <description>Asthma Control Test (ACT) Score; Minimum score = 5 (poor control of asthma). Maximum score = 25 (complete control of asthma). Higher scores reflect greater asthma control.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Nasal Congestion</condition>
    <arm_group>
      <arm_group_label>Interventional</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sonu Acoustic Resonance Therapy</intervention_name>
      <description>Participants will receive Sonu treatment twice a day for 90 days</description>
      <arm_group_label>Interventional</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age and older&#xD;
  &#xD;
            -  Present with symptoms of chronic nasal congestion&#xD;
  &#xD;
            -  Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to&#xD;
               3 scale at the time of screening&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Head, nasal or sinus surgery within 3 months&#xD;
  &#xD;
            -  Pregnancy&#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>Jacob Johnson, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>San Francisco Otolaryngology Medical Group</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paramesh Gopi, PhD</last_name>
      <phone>408-316-3631</phone>
      <email>pgopi@soundhealth.life</email>
    </overall_contact>
    <location>
      <facility>
        <name>San Francisco Otolaryngology Medical Group</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacob Johnson, MD</last_name>
        <phone>415-362-5443</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024564
  org study id: CP-007
  nct id: NCT06024564
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion
  This is an interventional study designed to gather data on real world utilization of Acoustic
        Resonance Therapy for treating moderate to severe nasal congestion
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Weekly Utilization-Frequency
  time frame: 90 days
  description: Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week
  measure: Weekly Utilization-Duration
  time frame: 90 days
  description: Weekly utilization of Sonu treatment, measured as the duration of treatment received per week
  measure: Total Nasal Symptom Score (TNSS)
  time frame: 90 days
  description: 24-hour TNSS; Minimum score=0 (no symptoms), Maximum score=12 (severe symptoms). Lower scores are better and reflect less symptoms.
  measure: Asthma Control
  time frame: 90 days
  description: Asthma Control Test (ACT) Score; Minimum score = 5 (poor control of asthma). Maximum score = 25 (complete control of asthma). Higher scores reflect greater asthma control.
  arm group label: Interventional
  arm group type: Experimental
  description: Participants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days
  intervention type: Device
  intervention name: Sonu Acoustic Resonance Therapy
  description: Participants will receive Sonu treatment twice a day for 90 days
  arm group label: Interventional
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacob Johnson, MD
  role: Principal Investigator
  affiliation: San Francisco Otolaryngology Medical Group
  last name: Paramesh Gopi, PhD
  phone: 408-316-3631
  email: pgopi@soundhealth.life
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No