<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/NCT03279510</url>
  </required_header>
  <id_info>
    <org_study_id>C2396-P</org_study_id>
    <nct_id>NCT03279510</nct_id>
  </id_info>
  <brief_title>Hearing Aids and the Brain</brief_title>
  <official_title>Hearing Aids and the Brain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hearing aids are being fit on inexperienced hearing aid users and the short-term and&#xD;
      long-term effects are measured. This research aims to improve understanding of the individual&#xD;
      factors that contribute to receiving benefit from hearing aids and lead to more&#xD;
      individualized treatment of hearing loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hearing aids are used to improve audibility for patients with hearing loss and improve speech&#xD;
      perception. In addition to these immediate benefits, amplification has the potential to have&#xD;
      long-term effects on higher level auditory processing abilities, such as cognition or other&#xD;
      abilities required for complex listening tasks. These long-term acclimatization effects are&#xD;
      not well understood and merit further behavioral and physiological examination. Hearing aids&#xD;
      will be fit on inexperienced hearing aid users and outcome measures will be used to determine&#xD;
      immediate and long-term effects of hearing aids. This research may provide a more detailed&#xD;
      view of individual differences that contribute to receiving benefit from a hearing aid and&#xD;
      may lead to more individualized treatment of hearing loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2018</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>Evoked potential latency</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Latency will be measured in milliseconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evoked potential amplitude</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Amplitude will be measured in microvolts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency following response magnitude</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Magnitude of response measured in nanovolts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency following response timing</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Timing measured by cross-correlation between stimulus and response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ongoing electroencephalography power</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>EEG power as a function of frequency recorded during words-in-noise measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment score</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Assessment score from 1 to 30</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reading Span</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Percent correct recall on working memory task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hearing aid usage</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Data logging from the hearing aid will provide usage in hours per day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Word-in-noise perception testing</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Listening invested/required effort</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Participants' rating of the effort required (0-9) and invested (0-9) for listening task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working memory testing</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Performance on auditory working memory task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glasgow Hearing Aid Benefit Profile (GHABP)</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Participants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Hearing aids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All study participants will be fit with hearing aids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hearing aids</intervention_name>
    <description>Subjects are fit with hearing aids.</description>
    <arm_group_label>Hearing aids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 years of age or older&#xD;
&#xD;
          -  Bilateral, mild to moderately severe hearing loss&#xD;
&#xD;
          -  Inexperienced hearing aid users&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject deciding that they do not wish to wear hearing aids as necessitated per study&#xD;
             protocol&#xD;
&#xD;
          -  Audiometric thresholds that suggest research stimuli would not be audible&#xD;
&#xD;
          -  Conductive hearing loss and/or other significant ear or hearing problems&#xD;
&#xD;
          -  Non-native English speakers&#xD;
&#xD;
          -  Conditions or circumstances that would preclude a participant from wearing hearing&#xD;
             aids consistently or finishing the study&#xD;
&#xD;
          -  An inability to perform or complete the experimental tasks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Curtis J. Billings, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Portland Health Care System, Portland, OR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <disposition_first_submitted>January 31, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>June 8, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 24, 2022</disposition_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>auditory perception</keyword>
  <keyword>hearing</keyword>
  <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>
  <pending_results>
    <submitted>May 30, 2023</submitted>
    <returned>June 23, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03279510
org study id: C2396-P
nct id: NCT03279510
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Hearing aids are being fit on inexperienced hearing aid users and the short-term and
      long-term effects are measured. This research aims to improve understanding of the individual
      factors that contribute to receiving benefit from hearing aids and lead to more
      individualized treatment of hearing loss.
Hearing aids are used to improve audibility for patients with hearing loss and improve speech
      perception. In addition to these immediate benefits, amplification has the potential to have
      long-term effects on higher level auditory processing abilities, such as cognition or other
      abilities required for complex listening tasks. These long-term acclimatization effects are
      not well understood and merit further behavioral and physiological examination. Hearing aids
      will be fit on inexperienced hearing aid users and outcome measures will be used to determine
      immediate and long-term effects of hearing aids. This research may provide a more detailed
      view of individual differences that contribute to receiving benefit from a hearing aid and
      may lead to more individualized treatment of hearing loss.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evoked potential latency
time frame: Approximately 1 year
description: Latency will be measured in milliseconds
measure: Evoked potential amplitude
time frame: Approximately 1 year
description: Amplitude will be measured in microvolts
measure: Frequency following response magnitude
time frame: Approximately 1 year
description: Magnitude of response measured in nanovolts
measure: Frequency following response timing
time frame: Approximately 1 year
description: Timing measured by cross-correlation between stimulus and response
measure: Ongoing electroencephalography power
time frame: Approximately 1 year
description: EEG power as a function of frequency recorded during words-in-noise measure
measure: Montreal Cognitive Assessment score
time frame: Approximately 1 year
description: Assessment score from 1 to 30
measure: Reading Span
time frame: Approximately 1 year
description: Percent correct recall on working memory task
measure: Hearing aid usage
time frame: Approximately 1 year
description: Data logging from the hearing aid will provide usage in hours per day
measure: Word-in-noise perception testing
time frame: Approximately 1 year
description: Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test
measure: Listening invested/required effort
time frame: Approximately 1 year
description: Participants' rating of the effort required (0-9) and invested (0-9) for listening task
measure: Working memory testing
time frame: Approximately 1 year
description: Performance on auditory working memory task
measure: Glasgow Hearing Aid Benefit Profile (GHABP)
time frame: Approximately 1 year
description: Participants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations
arm group label: Hearing aids
arm group type: Experimental
description: All study participants will be fit with hearing aids.
intervention type: Device
intervention name: hearing aids
description: Subjects are fit with hearing aids.
arm group label: Hearing aids
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Curtis J. Billings, PhD
role: Principal Investigator
affiliation: VA Portland Health Care System, Portland, OR
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
sharing ipd: No
submitted: May 30, 2023
returned: June 23, 2023