<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/NCT01663467</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH_YHK_TRT</org_study_id>
    <nct_id>NCT01663467</nct_id>
  </id_info>
  <brief_title>Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy</brief_title>
  <official_title>Efficacy of Internet and Smartphone Application-delivered TRT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prove the efficacy of the internet and smartphone&#xD;
      application-delivered tinnitus retraining therapy (TRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      to investigate the effect of TRT with minimized counseling&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    there was no participants who were enrolled in this study&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus Handicap Inventory (THI)</measure>
    <time_frame>6 months</time_frame>
    <description>THI will be evaluated 6 months after TRT using smatrphone and web</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Ginkgo biloba only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control group Ginexin-F 80mg tablet will be given twice a day for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ginkgo biloba + modified TRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.&#xD;
Ginexin-F 80mg tablet will be given twice a day for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ginkgo biloba</intervention_name>
    <description>Ginexin-F 80mg tablet will be given twice a day for 6 months.</description>
    <arm_group_label>Ginkgo biloba + modified TRT</arm_group_label>
    <arm_group_label>Ginkgo biloba only</arm_group_label>
    <other_name>Ginexin-F</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>modified TRT</intervention_name>
    <description>modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.&#xD;
Ginexin-F 80mg tablet will be given twice a day for 6 months.</description>
    <arm_group_label>Ginkgo biloba + modified TRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic subjective tinnitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  THI &lt; 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YOUNG HO KIM, MD., PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>October 23, 2016</last_update_submitted>
  <last_update_submitted_qc>October 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>YOUNG HO KIM</investigator_full_name>
    <investigator_title>Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Boramae Medical Center</investigator_title>
  </responsible_party>
  <keyword>tinnitus</keyword>
  <keyword>smartphone</keyword>
  <keyword>Web</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</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/NCT01663467
org study id: SNUH_YHK_TRT
nct id: NCT01663467
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to prove the efficacy of the internet and smartphone
      application-delivered tinnitus retraining therapy (TRT).
to investigate the effect of TRT with minimized counseling
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Tinnitus Handicap Inventory (THI)
time frame: 6 months
description: THI will be evaluated 6 months after TRT using smatrphone and web
arm group label: Ginkgo biloba only
arm group type: Active Comparator
description: control group Ginexin-F 80mg tablet will be given twice a day for 6 months.
arm group label: Ginkgo biloba + modified TRT
arm group type: Experimental
description: experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.
Ginexin-F 80mg tablet will be given twice a day for 6 months.
intervention type: Drug
intervention name: Ginkgo biloba
description: Ginexin-F 80mg tablet will be given twice a day for 6 months.
arm group label: Ginkgo biloba + modified TRT
arm group label: Ginkgo biloba only
other name: Ginexin-F
intervention type: Behavioral
intervention name: modified TRT
description: modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.
Ginexin-F 80mg tablet will be given twice a day for 6 months.
arm group label: Ginkgo biloba + modified TRT
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: YOUNG HO KIM, MD., PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: YOUNG HO KIM
investigator title: Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Boramae Medical Center
mesh term: Tinnitus
sharing ipd: No