<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/NCT04482998</url>
  </required_header>
  <id_info>
    <org_study_id>2131-2020</org_study_id>
    <nct_id>NCT04482998</nct_id>
  </id_info>
  <brief_title>Efficacy of Various Treatments for Acute Acoustic Trauma.</brief_title>
  <official_title>Efficacy of Various Treatments for Acute Acoustic Trauma in the Israeli Defense Force.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Corps, Israel Defense Force</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Corps, Israel Defense Force</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Acute acoustic trauma is a growing concern in the IDF. there is currently no accepted&#xD;
      treatment. The present retrospective study is intended to evaluate the efficacy of different&#xD;
      treatment modalities in the IDF between 01/01/2010 and 15/06/2020.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hearing improvement</measure>
    <time_frame>until 1 year of acoustic trauma.</time_frame>
    <description>dB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tinnitus</measure>
    <time_frame>until 1 year of acoustic trauma.</time_frame>
    <description>Qualitative - subjective</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Otoacoustic Emissions (OAE)</measure>
    <time_frame>until 1 year of acoustic trauma.</time_frame>
    <description>dB</description>
  </secondary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Acute Acoustic Trauma</condition>
  <arm_group>
    <arm_group_label>Steroids only - early</arm_group_label>
    <description>treatment was initiated within 7 days of acoustic trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early combined steroid and hyperbaric oxygen therapy</arm_group_label>
    <description>treatment was initiated within 7 days of acoustic trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed combined steroid and hyperbaric oxygen therapy</arm_group_label>
    <description>treatment was initiated after 7 days of acoustic trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early sequential steroid followed by HBO therapy</arm_group_label>
    <description>treatment was initiated within 7 days of acoustic trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed sequential steroid followed by HBO therapy</arm_group_label>
    <description>treatment was initiated after 7 days of acoustic trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperbaric oxygen therapy only</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Steroid only - delayed</arm_group_label>
    <description>treatment was initiated after 7 days of acoustic trauma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention - retrospective study</intervention_name>
    <description>No intervention - retrospective study</description>
    <arm_group_label>Delayed combined steroid and hyperbaric oxygen therapy</arm_group_label>
    <arm_group_label>Delayed sequential steroid followed by HBO therapy</arm_group_label>
    <arm_group_label>Early combined steroid and hyperbaric oxygen therapy</arm_group_label>
    <arm_group_label>Early sequential steroid followed by HBO therapy</arm_group_label>
    <arm_group_label>Hyperbaric oxygen therapy only</arm_group_label>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_label>Steroid only - delayed</arm_group_label>
    <arm_group_label>Steroids only - early</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects that served in the IDF and sustained an acute acoustic trauma between 01.01.2010&#xD;
        and 15.06.2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosed with acute acoustic trauma.&#xD;
&#xD;
          -  Hearing exam performed at least 24 hours after acute acoustic trauma.&#xD;
&#xD;
          -  There was a reduction of at least 30dB in the 3,000-8,000 Hz frequency range in the&#xD;
             first hearing exam performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known hearing impairment prior to acute acoustic trauma.&#xD;
&#xD;
          -  Subjects lost from follow up.&#xD;
&#xD;
          -  Another diagnosis is more likely than hearing loss due to acute acoustic trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yoni Evgeni Gutkovich, M.D/Ph.D</last_name>
    <phone>+972526894497</phone>
    <email>gutkovichj@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dror Tal, Ph.D</last_name>
    <phone>+972549096080</phone>
    <email>tldror1@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Israeli Navy Medical Institute</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Corps, Israel Defense Force</investigator_affiliation>
    <investigator_full_name>Yoni Gutkovich</investigator_full_name>
    <investigator_title>deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.</investigator_title>
  </responsible_party>
  <keyword>Hyperbaric Oxygen Therapy</keyword>
  <keyword>Acute Acoustic Trauma</keyword>
  <keyword>Steroids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss, Noise-Induced</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04482998
org study id: 2131-2020
nct id: NCT04482998
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute acoustic trauma is a growing concern in the IDF. there is currently no accepted
      treatment. The present retrospective study is intended to evaluate the efficacy of different
      treatment modalities in the IDF between 01/01/2010 and 15/06/2020.
observational model: Cohort
time perspective: Retrospective
measure: Hearing improvement
time frame: until 1 year of acoustic trauma.
description: dB
measure: Tinnitus
time frame: until 1 year of acoustic trauma.
description: Qualitative - subjective
measure: Otoacoustic Emissions (OAE)
time frame: until 1 year of acoustic trauma.
description: dB
arm group label: Steroids only - early
description: treatment was initiated within 7 days of acoustic trauma.
arm group label: Early combined steroid and hyperbaric oxygen therapy
description: treatment was initiated within 7 days of acoustic trauma.
arm group label: Delayed combined steroid and hyperbaric oxygen therapy
description: treatment was initiated after 7 days of acoustic trauma.
arm group label: Early sequential steroid followed by HBO therapy
description: treatment was initiated within 7 days of acoustic trauma.
arm group label: Delayed sequential steroid followed by HBO therapy
description: treatment was initiated after 7 days of acoustic trauma.
arm group label: Hyperbaric oxygen therapy only
arm group label: No treatment
arm group label: Steroid only - delayed
description: treatment was initiated after 7 days of acoustic trauma.
intervention type: Other
intervention name: No intervention - retrospective study
description: No intervention - retrospective study
arm group label: Delayed combined steroid and hyperbaric oxygen therapy
arm group label: Delayed sequential steroid followed by HBO therapy
arm group label: Early combined steroid and hyperbaric oxygen therapy
arm group label: Early sequential steroid followed by HBO therapy
arm group label: Hyperbaric oxygen therapy only
arm group label: No treatment
arm group label: Steroid only - delayed
arm group label: Steroids only - early
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Yoni Evgeni Gutkovich, M.D/Ph.D
phone: +972526894497
email: gutkovichj@gmail.com
last name: Dror Tal, Ph.D
phone: +972549096080
email: tldror1@gmail.com
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Medical Corps, Israel Defense Force
investigator full name: Yoni Gutkovich
investigator title: deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.
mesh term: Hearing Loss, Noise-Induced
mesh term: Wounds and Injuries
sharing ipd: No