<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/NCT03766152</url>
  </required_header>
  <id_info>
    <org_study_id>1757/2018</org_study_id>
    <nct_id>NCT03766152</nct_id>
  </id_info>
  <brief_title>Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users</brief_title>
  <official_title>Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dominik Riss</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients implanted with a Bonebridge will be asked to be part of the study. The study&#xD;
      subjects are enrolled into the study according to inclusion criteria.&#xD;
&#xD;
      Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60&#xD;
      min. After this time period patients will be asked to use the adhesive device instead of the&#xD;
      Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed&#xD;
      at the beginning of the study and at the end of three weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out&#xD;
      two questionnaires. They will then wear the device for 30-60 minutes and decide if they want&#xD;
      to wear the device for the remaining study time of three weeks. Patients who do not have&#xD;
      sufficient benefit from the device or do not feel comfortable with it do not enter the second&#xD;
      study period of wearing the device for three weeks. Patients will be asked to comment on&#xD;
      their experiences after 30 to 60 minutes explaining why they do not want to enter the second&#xD;
      part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the&#xD;
      second study period, will be asked to wear the hearing device as long as comfortable to them&#xD;
      every day and mark time of device usage, battery life, changes of the adhesive adapter, sound&#xD;
      quality and comfort related remarks in a diary. After three weeks patients will return to the&#xD;
      outpatient ́s department for an audiological assessment and a second set of quality of&#xD;
      hearing and quality of life questionnaire.&#xD;
&#xD;
      No patients will be implanted with a Bonebridge as part of the study.&#xD;
&#xD;
      Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and&#xD;
      Oldenburg sentence test.&#xD;
&#xD;
      Questionnaires consist of the AQol-8D and the SSQ-12&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">December 13, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Average functional hearing gain</measure>
    <time_frame>3 weeks</time_frame>
    <description>The primary endpoint of the study is the average functional hearing gain evaluated by the free field audiometry (at 4 different frequencies) using the bone conduction device compared to the unaided situation. To compare the two hearing devices the following primary endpoint measure will be calculated: Δmean= {(Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T1 (=Δ1)) + (Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T2 (=Δ2))} divided by two. Measuring both hearing devices at both timepoints and using the mean difference (Δmean) enables adjustment for a possible underlying customization effect.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AQoL-8D (quality of life)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Will be measured by comparing Quality of Life as assessed with AQoL - 8D at the beginning of the study and the end of the study (The result of the AQoL-8D is a number)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of hearing</measure>
    <time_frame>3 weeks</time_frame>
    <description>Quality of hearing as assessed with the SSQ 12 questionnaire will be compared at the beginning of the study to the results after the three weeks with the adhesive device.&#xD;
The results of the SSQ-12 is a number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Word recognition score</measure>
    <time_frame>3 weeks</time_frame>
    <description>Further secondary outcomes will be assessed by comparing the results of the word recognition test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Word recognition is measured in percent at two different noise levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sentence test</measure>
    <time_frame>3 weeks</time_frame>
    <description>Further secondary outcomes will be assessed by comparing the results of the sentence test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Sentence test results are measured as percent at a certain volume level (dB).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Bone Conduction Deafness</condition>
  <condition>Hearing Loss, Conductive</condition>
  <arm_group>
    <arm_group_label>Adhear</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will be fitted with an adhesive bone conduction device for three weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhesive bone conduction hearing aid (ADHEAR - Med El)</intervention_name>
    <description>Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter</description>
    <arm_group_label>Adhear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients implanted with a Bonebridge device and are active users&#xD;
&#xD;
          -  Unilateral and/or bilateral conductive hearing loss (CHL)&#xD;
&#xD;
          -  Subjects aged 13 years or older&#xD;
&#xD;
          -  Capable of the German language&#xD;
&#xD;
          -  Willingness and ability to perform all tests required for the study&#xD;
&#xD;
          -  Signed, and dated informed consent before the start of any study specific procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Patient is intolerant of the materials as described by Manufacturer's IFU&#xD;
&#xD;
          -  Patient presents with a skin or scalp condition that may preclude the attachment of&#xD;
             the adhesive adapter.&#xD;
&#xD;
          -  Patient cannot perform the audiological tests or is unable to fill out the&#xD;
             questionnaires.&#xD;
&#xD;
          -  Patient presents with retrocochlear, or central auditory disorder.&#xD;
&#xD;
          -  any physical, psychological, or emotional disorder that would interfere with the&#xD;
             ability to perform on test and rehabilitation procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MUW, AKH</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 28, 2019</last_update_submitted>
  <last_update_submitted_qc>December 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dominik Riss</investigator_full_name>
    <investigator_title>Assoc. Prof PD Dr.</investigator_title>
  </responsible_party>
  <keyword>Hearing aid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Conductive</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/NCT03766152
org study id: 1757/2018
nct id: NCT03766152
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients implanted with a Bonebridge will be asked to be part of the study. The study
      subjects are enrolled into the study according to inclusion criteria.

      Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60
      min. After this time period patients will be asked to use the adhesive device instead of the
      Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed
      at the beginning of the study and at the end of three weeks.
Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out
      two questionnaires. They will then wear the device for 30-60 minutes and decide if they want
      to wear the device for the remaining study time of three weeks. Patients who do not have
      sufficient benefit from the device or do not feel comfortable with it do not enter the second
      study period of wearing the device for three weeks. Patients will be asked to comment on
      their experiences after 30 to 60 minutes explaining why they do not want to enter the second
      part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the
      second study period, will be asked to wear the hearing device as long as comfortable to them
      every day and mark time of device usage, battery life, changes of the adhesive adapter, sound
      quality and comfort related remarks in a diary. After three weeks patients will return to the
      outpatient ́s department for an audiological assessment and a second set of quality of
      hearing and quality of life questionnaire.

      No patients will be implanted with a Bonebridge as part of the study.

      Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and
      Oldenburg sentence test.

      Questionnaires consist of the AQol-8D and the SSQ-12
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average functional hearing gain
time frame: 3 weeks
description: The primary endpoint of the study is the average functional hearing gain evaluated by the free field audiometry (at 4 different frequencies) using the bone conduction device compared to the unaided situation. To compare the two hearing devices the following primary endpoint measure will be calculated: Δmean= {(Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T1 (=Δ1)) + (Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T2 (=Δ2))} divided by two. Measuring both hearing devices at both timepoints and using the mean difference (Δmean) enables adjustment for a possible underlying customization effect.
measure: AQoL-8D (quality of life)
time frame: 3 weeks
description: Will be measured by comparing Quality of Life as assessed with AQoL - 8D at the beginning of the study and the end of the study (The result of the AQoL-8D is a number)
measure: Quality of hearing
time frame: 3 weeks
description: Quality of hearing as assessed with the SSQ 12 questionnaire will be compared at the beginning of the study to the results after the three weeks with the adhesive device.
The results of the SSQ-12 is a number
measure: Word recognition score
time frame: 3 weeks
description: Further secondary outcomes will be assessed by comparing the results of the word recognition test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Word recognition is measured in percent at two different noise levels
measure: Sentence test
time frame: 3 weeks
description: Further secondary outcomes will be assessed by comparing the results of the sentence test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Sentence test results are measured as percent at a certain volume level (dB).
arm group label: Adhear
arm group type: Other
description: Patients will be fitted with an adhesive bone conduction device for three weeks
intervention type: Device
intervention name: Adhesive bone conduction hearing aid (ADHEAR - Med El)
description: Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter
arm group label: Adhear
criteria: 
gender: All
minimum age: 13 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dominik Riss
investigator title: Assoc. Prof PD Dr.
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Conductive
sharing ipd: No