<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/NCT03771287</url>
  </required_header>
  <id_info>
    <org_study_id>2017-5953</org_study_id>
    <nct_id>NCT03771287</nct_id>
  </id_info>
  <brief_title>Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)</brief_title>
  <acronym>OtiS</acronym>
  <official_title>Learning to Listen in Noise: A Double-blind Randomized Control Trial of a New Hearing Aid Noise Reduction System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oticon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing&#xD;
      aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid&#xD;
      users. Using a double-blind experimental design, the investigators aim to compare two&#xD;
      treatment groups of pediatric (ages 6-12) patients with symmetrical sensorineural hearing&#xD;
      losses ranging from the mild to moderately-severe degree. One group will be fit with&#xD;
      bilateral Oticon OPN™ behind-the-ear hearing aids set with an omni-directional microphone&#xD;
      setting. The other group will be fit with the same hearing aid model with the OSN algorithm&#xD;
      enabled. Participants from the groups will be age and audiogram-matched. The investigators&#xD;
      will evaluate hearing aid benefit through word recognition in noise (behavioral testing) and&#xD;
      everyday hearing/listening abilities (parental/legal guardian reported) at hearing aid&#xD;
      fitting and 6-8 months post fitting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OpenSound Navigator (OSN) is a speech enhancement hearing aid algorithm developed by Oticon&#xD;
      that utilizes an adaptive directional microphone system with an automatic gain control noise&#xD;
      reduction program. This hearing aid feature is intended for adult hearing aid users and its&#xD;
      potential benefits of speech, vocabulary and listening development in pediatric users has not&#xD;
      been investigated. Here the investigators aim to evaluate the efficacy of OSN programming in&#xD;
      pediatric hearing aid users (6-12 years of age) diagnosed with a symmetrical sensorineural&#xD;
      hearing loss in the mild to moderately-severe range. The investigators will use a&#xD;
      double-blind randomized control methodology of two participant matched (based on age and&#xD;
      audiometric configuration) groups. The first group will include pediatric patients fit with&#xD;
      bilateral Oticon OPN™ behind-the-ear hearing aids with the standard Omni-directional&#xD;
      microphone setting enabled. Group two will include pediatric patients fit with the same&#xD;
      hearing aid model with the OSN feature enabled. Participants will undergo standard&#xD;
      audiometric diagnostic testing and will be fit with the hearing aids by a licensed clinical&#xD;
      audiologist. Participants are required to wear the hearing aids full time (at least 8 hours&#xD;
      per day average) during the duration of the study. The evaluation measures will include&#xD;
      speech recognition testing in controlled background noise and the Speech, Spatial and&#xD;
      Qualities of Hearing Scale questionnaire (completed by parents/legal guardian). Testing will&#xD;
      be performed within a week of the hearing aid fitting and 6-8 months post fitting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>Double (Participant, Investigator)</masking>
    <masking_description>Double-blinded randomized control trial of OpenSound Navigator (OSN) enabled/disabled hearing aids. Only the fitting audiologist will know if the OSN algorithm is enabled or disabled in the research hearing aids. Will be un-blinded after data collection is complete in order to carry out group comparison analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Word Recognition Abilities at 6 to 8 Months</measure>
    <time_frame>6-8 months</time_frame>
    <description>Aided speech perception in noise within a week of hearing aid fitting and again 6-8 months later.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months</measure>
    <time_frame>6-8 months</time_frame>
    <description>Speech, Spatial and Qualities of Hearing Scale (SSQ), a survey utilizing an ordinal scale specifically measuring hearing aid benefit with regard to speech understanding, spatial awareness, perceptual quality of sound, and conversation, will be completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for 6-8 months. There are 4 survey sections. Section A: Speech has 8 questions, Section B: Spatial Hearing has 5 questions, Section C: Qualities of Hearing has 8 questions and Section D: Conversational Uses of Hearing has 5 questions. Each question uses a scale ranging from 0 (poorest possible outcome) to 100 (best possible outcome). Each section calculates an average score across the corresponding questions for a total of 4 individual scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing aid use time</measure>
    <time_frame>6-8 months</time_frame>
    <description>Average daily use of hearing aids.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hearing Impairment</condition>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>OpenSound Navigator (OSN) Hearing Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>omni-directional Hearing Aid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the Omni-directional microphone system enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oticon OpenSound Navigator speech enhancement algorithm</intervention_name>
    <description>OpenSound Navigator (OSN) is a speech enhancement algorithm developed by Oticon. The feature is built in Oticon's current OPN™ hearing aid platform and can be adjusted and disabled in the programming. It is designed to automatically enhance speech while reducing unwanted background noise to improve communication for the user.</description>
    <arm_group_label>OpenSound Navigator (OSN) Hearing Aid</arm_group_label>
    <other_name>OSN</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oticon omni-directional microphone algorithm</intervention_name>
    <description>Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.</description>
    <arm_group_label>omni-directional Hearing Aid</arm_group_label>
    <other_name>omni-directional mic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children ages 6 to 13 years&#xD;
&#xD;
          -  English as the primary home language&#xD;
&#xD;
          -  positive for bilateral symmetrical mild to moderately-severe sensorineural hearing&#xD;
             loss&#xD;
&#xD;
          -  currently using hearing aids that were dispensed at least 18 months prior to&#xD;
             enrollment of the study&#xD;
&#xD;
          -  negative for major cognitive handicap or developmental delay that would prevent or&#xD;
             restrict participation, as determined by the PI or designee&#xD;
&#xD;
          -  negative for learning disability, for example attention-deficit/hyperactivity&#xD;
             disorder, as determined by the PI or designee&#xD;
&#xD;
          -  negative for serious neurological or psychiatric disease that would prevent or&#xD;
             restrict participation, as determined by the PI or designee&#xD;
&#xD;
          -  informed consent of parent/guardian&#xD;
&#xD;
          -  assent of participating child if aged 11 years and over&#xD;
&#xD;
          -  standard MRI inclusion criteria as set by the Cincinnati Children's Hospital Medical&#xD;
             Center department of Radiology&#xD;
&#xD;
          -  not currently pregnant or breast feeding&#xD;
&#xD;
          -  willingness and ability of the participant and/or the participant's caregiver to&#xD;
             comply with study requirements&#xD;
&#xD;
          -  no history of medical neglect of caregiver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R Moore, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</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>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</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/NCT03771287
org study id: 2017-5953
nct id: NCT03771287
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing
      aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid
      users. Using a double-blind experimental design, the investigators aim to compare two
      treatment groups of pediatric (ages 6-12) patients with symmetrical sensorineural hearing
      losses ranging from the mild to moderately-severe degree. One group will be fit with
      bilateral Oticon OPN™ behind-the-ear hearing aids set with an omni-directional microphone
      setting. The other group will be fit with the same hearing aid model with the OSN algorithm
      enabled. Participants from the groups will be age and audiogram-matched. The investigators
      will evaluate hearing aid benefit through word recognition in noise (behavioral testing) and
      everyday hearing/listening abilities (parental/legal guardian reported) at hearing aid
      fitting and 6-8 months post fitting.
OpenSound Navigator (OSN) is a speech enhancement hearing aid algorithm developed by Oticon
      that utilizes an adaptive directional microphone system with an automatic gain control noise
      reduction program. This hearing aid feature is intended for adult hearing aid users and its
      potential benefits of speech, vocabulary and listening development in pediatric users has not
      been investigated. Here the investigators aim to evaluate the efficacy of OSN programming in
      pediatric hearing aid users (6-12 years of age) diagnosed with a symmetrical sensorineural
      hearing loss in the mild to moderately-severe range. The investigators will use a
      double-blind randomized control methodology of two participant matched (based on age and
      audiometric configuration) groups. The first group will include pediatric patients fit with
      bilateral Oticon OPN™ behind-the-ear hearing aids with the standard Omni-directional
      microphone setting enabled. Group two will include pediatric patients fit with the same
      hearing aid model with the OSN feature enabled. Participants will undergo standard
      audiometric diagnostic testing and will be fit with the hearing aids by a licensed clinical
      audiologist. Participants are required to wear the hearing aids full time (at least 8 hours
      per day average) during the duration of the study. The evaluation measures will include
      speech recognition testing in controlled background noise and the Speech, Spatial and
      Qualities of Hearing Scale questionnaire (completed by parents/legal guardian). Testing will
      be performed within a week of the hearing aid fitting and 6-8 months post fitting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-blinded randomized control trial of OpenSound Navigator (OSN) enabled/disabled hearing aids. Only the fitting audiologist will know if the OSN algorithm is enabled or disabled in the research hearing aids. Will be un-blinded after data collection is complete in order to carry out group comparison analysis.
measure: Change from Baseline Word Recognition Abilities at 6 to 8 Months
time frame: 6-8 months
description: Aided speech perception in noise within a week of hearing aid fitting and again 6-8 months later.
measure: Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months
time frame: 6-8 months
description: Speech, Spatial and Qualities of Hearing Scale (SSQ), a survey utilizing an ordinal scale specifically measuring hearing aid benefit with regard to speech understanding, spatial awareness, perceptual quality of sound, and conversation, will be completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for 6-8 months. There are 4 survey sections. Section A: Speech has 8 questions, Section B: Spatial Hearing has 5 questions, Section C: Qualities of Hearing has 8 questions and Section D: Conversational Uses of Hearing has 5 questions. Each question uses a scale ranging from 0 (poorest possible outcome) to 100 (best possible outcome). Each section calculates an average score across the corresponding questions for a total of 4 individual scores.
measure: Hearing aid use time
time frame: 6-8 months
description: Average daily use of hearing aids.
arm group label: OpenSound Navigator (OSN) Hearing Aid
arm group type: Experimental
description: Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.
arm group label: omni-directional Hearing Aid
arm group type: Active Comparator
description: Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the Omni-directional microphone system enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.
intervention type: Device
intervention name: Oticon OpenSound Navigator speech enhancement algorithm
description: OpenSound Navigator (OSN) is a speech enhancement algorithm developed by Oticon. The feature is built in Oticon's current OPN™ hearing aid platform and can be adjusted and disabled in the programming. It is designed to automatically enhance speech while reducing unwanted background noise to improve communication for the user.
arm group label: OpenSound Navigator (OSN) Hearing Aid
other name: OSN
intervention type: Device
intervention name: Oticon omni-directional microphone algorithm
description: Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.
arm group label: omni-directional Hearing Aid
other name: omni-directional mic
criteria: 
gender: All
minimum age: 6 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David R Moore, Ph.D.
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
sharing ipd: No