<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/NCT04449848</url>
  </required_header>
  <id_info>
    <org_study_id>0182-20</org_study_id>
    <nct_id>NCT04449848</nct_id>
  </id_info>
  <brief_title>The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear</brief_title>
  <official_title>The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</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>
      During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear&#xD;
      due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the&#xD;
      injection instead of lying down. They will be then asked to rate their taste as a reference&#xD;
      to the amount of fluid leaking to the throat through the eustachian tube.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>Bitter taste</measure>
    <time_frame>30 minutes</time_frame>
    <description>Bitter taste described by the patients using a questionnaire with a scale of 0 to 5</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Sudden Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Sitting after intra tympanic injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Sudden hearing loss sitting after intra tympanic injection of steroids</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sitting after intra tympanic injection</intervention_name>
    <description>Sitting after intra tympanic injection</description>
    <arm_group_label>Sitting after intra tympanic injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using&#xD;
             intra-tympanic injection of steroids to the middle ear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with abnormal sense of taste&#xD;
&#xD;
          -  Middle or inner ear anomaly&#xD;
&#xD;
          -  Eustachian tube dysfunction&#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_contact>
    <last_name>Yahav Oron, MD</last_name>
    <phone>+97236973573</phone>
    <email>oron.yahav@gmail.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 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>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Sudden</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04449848
org study id: 0182-20
nct id: NCT04449848
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear
      due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the
      injection instead of lying down. They will be then asked to rate their taste as a reference
      to the amount of fluid leaking to the throat through the eustachian tube.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bitter taste
time frame: 30 minutes
description: Bitter taste described by the patients using a questionnaire with a scale of 0 to 5
arm group label: Sitting after intra tympanic injection
arm group type: Experimental
description: Patients with Sudden hearing loss sitting after intra tympanic injection of steroids
intervention type: Other
intervention name: Sitting after intra tympanic injection
description: Sitting after intra tympanic injection
arm group label: Sitting after intra tympanic injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yahav Oron, MD
phone: +97236973573
email: oron.yahav@gmail.com
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Hearing Loss, Sudden
sharing ipd: No