<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/NCT04469946</url>
  </required_header>
  <id_info>
    <org_study_id>2017-5953-2</org_study_id>
    <nct_id>NCT04469946</nct_id>
  </id_info>
  <brief_title>Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)</brief_title>
  <official_title>Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
  </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. The study used a within-subjects design with pre- and post-comparisons involving&#xD;
      fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging&#xD;
      from the mild to moderately-severe degree. All participants were fit with bilateral Oticon&#xD;
      OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators&#xD;
      evaluated hearing aid benefit through word recognition in noise (behavioral testing) and&#xD;
      everyday hearing/listening abilities (parental/legal guardian reported) within one week of&#xD;
      the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).&#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 used a within-subjects&#xD;
      study design with pre- and post-comparisons. All participants were fit with bilateral Oticon&#xD;
      OPN™ behind-the-ear hearing aids with the OSN feature enabled. Participants will undergo&#xD;
      standard audiometric diagnostic testing and will be fit with the hearing aids by a licensed&#xD;
      clinical audiologist. Participants are required to wear the hearing aids full time (at least&#xD;
      6 hours per day average) during the duration of the study. The evaluation measures will&#xD;
      include 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 (pre-intervention) and two months post&#xD;
      fitting (post-intervention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pediatric hearing aid users (6 to 12 years old) participated in an intervention trial of a hearing aid with an integrated directionality and noise reduction program. Pre- to post-comparison measures were obtained after two months of intervention use.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Word Recognition in Noise Abilities</measure>
    <time_frame>2 months</time_frame>
    <description>Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal, the adaptive noise level changed to 2 dB increments. This continued for six more noise level reversals for an overall signal-to-noise ratio (SNR) threshold calculation. The final threshold score indicates the estimated SNR level in which the participant correctly recognizes monosyllabic words 50% of the time (SNR-50). This test was performed within a week of hearing aid fitting and again after two months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Word Recognition in Quiet Abilities</measure>
    <time_frame>2 months</time_frame>
    <description>Aided speech perception in quiet was evaluated within a week of hearing aid fitting and again after two months. Recorded sentences were presented at 50 dB SPL, and scoring was based on accuracy of each recited word.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Memory</measure>
    <time_frame>2 months</time_frame>
    <description>Long-term vocabulary memory and episodic memory were evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Picture Vocabulary test and the Picture Sequence Memory Test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive Function</measure>
    <time_frame>2 months</time_frame>
    <description>Executive function was evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Flanker Inhibitory Control and Attention test and and the Dimensional Change Card Sort test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mathematic Academic Performance</measure>
    <time_frame>2 months</time_frame>
    <description>Mathematic skills were evaluated using a standardized battery called the Woodcock-Johnson IV Test of Achievement (WJ-IV). Subtests included Applied Problems and Calculation. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Academic Language Performance</measure>
    <time_frame>2 months</time_frame>
    <description>Language skills were evaluated using WJ-IV. Subtests included Letter-Word Identification and Passage Comprehension. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Speech, Spatial Qualities of Hearing Scale (SSQ) Scores</measure>
    <time_frame>2 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, was completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for two 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>Glasgow Hearing Aid Benefit Profile Scores</measure>
    <time_frame>2 months</time_frame>
    <description>Glasgow Hearing Aid Benefit Profile, a survey utilizing an ordinal scale with regard to perceived hearing aid benefit was completed by parents/legal guardians within a week of the hearing aid fit and after two months of hearing aid use. It includes 24 questions assessing change in hearing disability, handicap, hearing aid use, benefit and satisfaction and residual (aided) disability relative to the benefit of their previous hearing aids. Each question uses a scale ranging from -100 (reduced benefit) to +100 (increased benefit) with all questions averaged to make a final numeric score.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hearing Impairment</condition>
  <condition>Sensorineural Hearing Loss, Bilateral</condition>
  <arm_group>
    <arm_group_label>Exploratory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Pre-intervention measures were obtained within one week of the hearing aid fit and post-intervention measures were obtained after two months of daily hearing aid use.</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>Exploratory</arm_group_label>
    <other_name>OSN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children ages 6 to 12 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>12 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>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 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>
    <mesh_term>Hearing Loss, Bilateral</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/NCT04469946
org study id: 2017-5953-2
nct id: NCT04469946
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: 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. The study used a within-subjects design with pre- and post-comparisons involving
      fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging
      from the mild to moderately-severe degree. All participants were fit with bilateral Oticon
      OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators
      evaluated hearing aid benefit through word recognition in noise (behavioral testing) and
      everyday hearing/listening abilities (parental/legal guardian reported) within one week of
      the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
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 used a within-subjects
      study design with pre- and post-comparisons. All participants were fit with bilateral Oticon
      OPN™ behind-the-ear hearing aids 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
      6 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 (pre-intervention) and two months post
      fitting (post-intervention).
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Pediatric hearing aid users (6 to 12 years old) participated in an intervention trial of a hearing aid with an integrated directionality and noise reduction program. Pre- to post-comparison measures were obtained after two months of intervention use.
primary purpose: Treatment
masking: None (Open Label)
measure: Word Recognition in Noise Abilities
time frame: 2 months
description: Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal, the adaptive noise level changed to 2 dB increments. This continued for six more noise level reversals for an overall signal-to-noise ratio (SNR) threshold calculation. The final threshold score indicates the estimated SNR level in which the participant correctly recognizes monosyllabic words 50% of the time (SNR-50). This test was performed within a week of hearing aid fitting and again after two months.
measure: Word Recognition in Quiet Abilities
time frame: 2 months
description: Aided speech perception in quiet was evaluated within a week of hearing aid fitting and again after two months. Recorded sentences were presented at 50 dB SPL, and scoring was based on accuracy of each recited word.
measure: Memory
time frame: 2 months
description: Long-term vocabulary memory and episodic memory were evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Picture Vocabulary test and the Picture Sequence Memory Test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
measure: Executive Function
time frame: 2 months
description: Executive function was evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Flanker Inhibitory Control and Attention test and and the Dimensional Change Card Sort test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
measure: Mathematic Academic Performance
time frame: 2 months
description: Mathematic skills were evaluated using a standardized battery called the Woodcock-Johnson IV Test of Achievement (WJ-IV). Subtests included Applied Problems and Calculation. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
measure: Academic Language Performance
time frame: 2 months
description: Language skills were evaluated using WJ-IV. Subtests included Letter-Word Identification and Passage Comprehension. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
measure: Speech, Spatial Qualities of Hearing Scale (SSQ) Scores
time frame: 2 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, was completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for two 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: Glasgow Hearing Aid Benefit Profile Scores
time frame: 2 months
description: Glasgow Hearing Aid Benefit Profile, a survey utilizing an ordinal scale with regard to perceived hearing aid benefit was completed by parents/legal guardians within a week of the hearing aid fit and after two months of hearing aid use. It includes 24 questions assessing change in hearing disability, handicap, hearing aid use, benefit and satisfaction and residual (aided) disability relative to the benefit of their previous hearing aids. Each question uses a scale ranging from -100 (reduced benefit) to +100 (increased benefit) with all questions averaged to make a final numeric score.
arm group label: Exploratory
arm group type: Experimental
description: Participants were fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Pre-intervention measures were obtained within one week of the hearing aid fit and post-intervention measures were obtained after two months of daily hearing aid use.
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: Exploratory
other name: OSN
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 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
mesh term: Hearing Loss, Bilateral
sharing ipd: No