<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/NCT03761927</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2018_36</org_study_id>
    <nct_id>NCT03761927</nct_id>
  </id_info>
  <brief_title>Physiological, Behavioural and Subjective Measures of Listening Effort</brief_title>
  <official_title>Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sonova AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sonova AG</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>
      Participants will perform two different listening tasks: (1) listening to, and repeating&#xD;
      back, sentence lists presented in noise, and (2) listening to short radio excerpts and&#xD;
      answering subsequent comprehension questions. At the same time participants are required to&#xD;
      perform a manual target-tracking task on a touch screen. During this study, continuous,&#xD;
      non-invasive physiological measurements (heart rate, skin conductance and&#xD;
      hemoencephalography) will be made from participants. Using this paradigm we will be assessing&#xD;
      the effect of different hearing aid processing algorithms on listening effort. The study&#xD;
      takes the form of a three factor (listening task x algorithm x signal-to-noise ratio),&#xD;
      within-subjects design. Each participant performs each listening task (about 4min long each)&#xD;
      with each algorithm (reference, noise reduction I, noise reduction II), at two&#xD;
      signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability data</measure>
    <time_frame>6 weeks</time_frame>
    <description>Heart rate variability will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Heart rate variability will be analysed in both the time [ms] and frequency [ms squared] domains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin conductance data</measure>
    <time_frame>6 weeks</time_frame>
    <description>Skin conductance will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. It is planned to analyse mean levels of skin conductance [micro-Siemens].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoencephalography data</measure>
    <time_frame>6 weeks</time_frame>
    <description>Hemoencephalography will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Hemoencephalography will be analysed simply as the ratio of the blue and red light [%] during auditory task performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual-task performance test 1</measure>
    <time_frame>6 weeks</time_frame>
    <description>Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (speech intelligibility in [%] correct). For the Secondary task performance the reaction time [ms] will be analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual-task performance test 2</measure>
    <time_frame>6 weeks</time_frame>
    <description>Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (comprehension questions [numbers] correct after listening to radio excerpts). For the Secondary task performance the reaction time [ms] will be analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Listening Effort rating</measure>
    <time_frame>6 weeks</time_frame>
    <description>Subjective Listening Effort will also be assessed through self-reported individual listening effort on a 14 point scale from &quot;only noise&quot; to &quot;no effort&quot; after each auditory task.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Hearing Aid without NR enabled.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hearing Aid without Noise Reduction (NR) enabled serves as reference condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hearing Aid with NR(1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hearing Aid with Noise Reduction I (NR) enabled.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hearing Aid with NR(2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hearing Aid with Noise Reduction II (NR) enabled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hearing Aid without NR enabled</intervention_name>
    <description>Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.</description>
    <arm_group_label>Hearing Aid without NR enabled.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hearing Aid with NR(1)</intervention_name>
    <description>Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.</description>
    <arm_group_label>Hearing Aid with NR(1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hearing Aid with NR(2)</intervention_name>
    <description>Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).</description>
    <arm_group_label>Hearing Aid with NR(2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy outer ear (without previous surgical procedures)&#xD;
&#xD;
          -  Ability to fill in a questionnaire conscientiously&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
          -  Minimum 1 year hearing aid experience&#xD;
&#xD;
          -  Moderate-Severe (N3-N5) hearing loss or Normal Hearing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to&#xD;
             the investigational product&#xD;
&#xD;
          -  Limited mobility and not in the position to attend weekly appointments&#xD;
&#xD;
          -  Inability to produce a reliable hearing test result&#xD;
&#xD;
          -  Massively limited dexterity&#xD;
&#xD;
          -  Known psychological problems&#xD;
&#xD;
          -  Known central hearing disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliane Raether</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sonova AG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sonova AG</name>
      <address>
        <city>Stäfa</city>
        <zip>8712</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</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>
  </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/NCT03761927
org study id: Sonova2018_36
nct id: NCT03761927
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants will perform two different listening tasks: (1) listening to, and repeating
      back, sentence lists presented in noise, and (2) listening to short radio excerpts and
      answering subsequent comprehension questions. At the same time participants are required to
      perform a manual target-tracking task on a touch screen. During this study, continuous,
      non-invasive physiological measurements (heart rate, skin conductance and
      hemoencephalography) will be made from participants. Using this paradigm we will be assessing
      the effect of different hearing aid processing algorithms on listening effort. The study
      takes the form of a three factor (listening task x algorithm x signal-to-noise ratio),
      within-subjects design. Each participant performs each listening task (about 4min long each)
      with each algorithm (reference, noise reduction I, noise reduction II), at two
      signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Heart rate variability data
time frame: 6 weeks
description: Heart rate variability will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Heart rate variability will be analysed in both the time [ms] and frequency [ms squared] domains.
measure: Skin conductance data
time frame: 6 weeks
description: Skin conductance will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. It is planned to analyse mean levels of skin conductance [micro-Siemens].
measure: Hemoencephalography data
time frame: 6 weeks
description: Hemoencephalography will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Hemoencephalography will be analysed simply as the ratio of the blue and red light [%] during auditory task performance.
measure: Dual-task performance test 1
time frame: 6 weeks
description: Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (speech intelligibility in [%] correct). For the Secondary task performance the reaction time [ms] will be analysed.
measure: Dual-task performance test 2
time frame: 6 weeks
description: Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (comprehension questions [numbers] correct after listening to radio excerpts). For the Secondary task performance the reaction time [ms] will be analysed.
measure: Subjective Listening Effort rating
time frame: 6 weeks
description: Subjective Listening Effort will also be assessed through self-reported individual listening effort on a 14 point scale from "only noise" to "no effort" after each auditory task.
arm group label: Hearing Aid without NR enabled.
arm group type: Active Comparator
description: Hearing Aid without Noise Reduction (NR) enabled serves as reference condition.
arm group label: Hearing Aid with NR(1)
arm group type: Experimental
description: Hearing Aid with Noise Reduction I (NR) enabled.
arm group label: Hearing Aid with NR(2)
arm group type: Experimental
description: Hearing Aid with Noise Reduction II (NR) enabled.
intervention type: Device
intervention name: Hearing Aid without NR enabled
description: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
arm group label: Hearing Aid without NR enabled.
intervention type: Device
intervention name: Hearing Aid with NR(1)
description: Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
arm group label: Hearing Aid with NR(1)
intervention type: Device
intervention name: Hearing Aid with NR(2)
description: Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
arm group label: Hearing Aid with NR(2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juliane Raether
role: Principal Investigator
affiliation: Sonova AG
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hearing Loss
sharing ipd: No