<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/NCT02245646</url>
  </required_header>
  <id_info>
    <org_study_id>AH-RG_03_06_2014</org_study_id>
    <nct_id>NCT02245646</nct_id>
  </id_info>
  <brief_title>Distortion Product After Stapedotomy Surgery</brief_title>
  <official_title>Subjektiv Verzerrter Höreindruck Nach Stapedotomie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at capturing for the first time at which frequencies and sound intensities&#xD;
      hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of&#xD;
      patients perceiving these sound distortions and the length of time over which the distortions&#xD;
      occur are assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being&#xD;
      normally mobile, a conductive hearing loss results. This conductive hearing loss is usually&#xD;
      compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes&#xD;
      bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from&#xD;
      the incus to the footplate of the removed stapes.&#xD;
&#xD;
      After surgery subjects sometimes state that the quality of sound is suboptimal, even though&#xD;
      their hearing ability has improved significantly. Some subjects subjectively hear distorted&#xD;
      sounds, which often disappear several weeks after surgery.&#xD;
&#xD;
      This study aims at capturing for the first time at which frequencies and sound intensities&#xD;
      these distortions are perceived. Additionally, the portion of patients perceiving these sound&#xD;
      distortions and the length of time over which the distortions occur are assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of distorted sound perception after stapedotomy surgery</measure>
    <time_frame>7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery</time_frame>
    <description>A psychoacoustic audiometric tests is performed; subjects are asked to press a button if the sound they hear is distorted, and this is tested at different frequencies and different level of loudness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on quality of hearing after Stapedotomy (APOSE)</measure>
    <time_frame>7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Distorted Sound Perception</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>No indication for stapedotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distortion positive</arm_group_label>
    <description>Subjects after stapedotomy perceiving sound distortions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distortion negative</arm_group_label>
    <description>Subjects after stapedotomy not perceiving sound distortions.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Control group: Healthy volunteers are recruited by flyers that are displayed in the waiting&#xD;
        zones of the ENT clinic.&#xD;
&#xD;
        Subjects with stapedotomy: Patients are being asked by the examining MD as soon as the&#xD;
        indication for stapedotomy is proven.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for stapedotomy&#xD;
&#xD;
          -  written consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not mentally able to give written consent&#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>
  <location>
    <facility>
      <name>Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>October 28, 2016</last_update_submitted>
  <last_update_submitted_qc>October 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02245646
org study id: AH-RG_03_06_2014
nct id: NCT02245646
lead sponsor: 
collaborator: 
has dmc: No
This study aims at capturing for the first time at which frequencies and sound intensities
      hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of
      patients perceiving these sound distortions and the length of time over which the distortions
      occur are assessed.
If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being
      normally mobile, a conductive hearing loss results. This conductive hearing loss is usually
      compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes
      bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from
      the incus to the footplate of the removed stapes.

      After surgery subjects sometimes state that the quality of sound is suboptimal, even though
      their hearing ability has improved significantly. Some subjects subjectively hear distorted
      sounds, which often disappear several weeks after surgery.

      This study aims at capturing for the first time at which frequencies and sound intensities
      these distortions are perceived. Additionally, the portion of patients perceiving these sound
      distortions and the length of time over which the distortions occur are assessed.
observational model: Case-Control
time perspective: Prospective
measure: Change of distorted sound perception after stapedotomy surgery
time frame: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
description: A psychoacoustic audiometric tests is performed; subjects are asked to press a button if the sound they hear is distorted, and this is tested at different frequencies and different level of loudness.
measure: Questionnaire on quality of hearing after Stapedotomy (APOSE)
time frame: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
arm group label: Control group
description: No indication for stapedotomy
arm group label: Distortion positive
description: Subjects after stapedotomy perceiving sound distortions
arm group label: Distortion negative
description: Subjects after stapedotomy not perceiving sound distortions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor