<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/NCT04431622</url>
  </required_header>
  <id_info>
    <org_study_id>415685-15</org_study_id>
    <nct_id>NCT04431622</nct_id>
  </id_info>
  <brief_title>Objective Measurement of Hearing Aid Benefit</brief_title>
  <official_title>Objective Measurement of Hearing Aid Benefit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, College Park</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hearing loss is a critical health concern in the rapidly aging population, affecting&#xD;
      approximately 22 million older individuals in the United States. Yet, only 30% of individuals&#xD;
      who would benefit from the use of hearing aids regularly use them. This project aims to&#xD;
      improve the benefit of hearing aids for older adults through incorporation of objective&#xD;
      neural measures to assess effects of hearing aid algorithms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hearing loss is among the top three major health conditions in older adults and has been&#xD;
      identified as a major modifiable risk factor for dementia. It is therefore imperative that&#xD;
      older adults receive effective treatment for hearing loss in a timely manner to prevent&#xD;
      losses in social, emotional, and cognitive function. The current hearing aid fitting is based&#xD;
      on audiometric thresholds, but this approach does not account for large individual&#xD;
      differences in auditory temporal perception and cognitive ability that may affect speech&#xD;
      understanding in challenging listening environments. At present, there is a gap in knowledge&#xD;
      of how best to fit hearing aids for individual listeners. The long-term goal is to improve&#xD;
      the benefit of hearing aids for older adults so that they can maintain independence and&#xD;
      quality of life. The overall objective of this proposal is to identify the neural temporal&#xD;
      processing mechanisms associated with individual differences in hearing aid benefit in older&#xD;
      adults with similar audiograms. The investigators will use the innovative approach of&#xD;
      combining complementary neural and behavioral measures to assess the effects of hearing aid&#xD;
      amplification on speech perception and effortful listening. The central hypothesis is that&#xD;
      the neural representation of the temporal envelope of speech can be used to predict hearing&#xD;
      aid benefit in older adults with hearing loss. The central hypothesis will be tested through&#xD;
      the pursuit of three aims: (1) Measure the extent to which amplification distorts the neural&#xD;
      and perceptual processing of temporal cues; (2) Quantify reductions in temporal envelope&#xD;
      tracking and increases in cognitive effort associated with amplification algorithms that&#xD;
      distort the temporal envelope of the speech signal; and (3) Investigate the use of objective&#xD;
      physiological measures of temporal processing to predict hearing aid benefit. The expected&#xD;
      outcome is the development of an objective, neurophysiological tool for use in the design and&#xD;
      fitting of advanced algorithms to maximize speech perception in a variety of listening&#xD;
      environments. This outcome is expected to have a positive impact on the treatment of hearing&#xD;
      loss and its sequelae in older adults, because it will lead to a better understanding of the&#xD;
      neural mechanisms contributing to successful use of hearing aids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study did not receive funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2022</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Anticipated">February 2027</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>Neural response fidelity</measure>
    <time_frame>Immediately post-treatment</time_frame>
    <description>Neuroelectric and neuromagnetic responses are recorded to amplified one-minute speech samples. Reconstruction of the speech envelope will be performed using a linear reconstruction matrix estimated via boosting. Reconstruction success is measured by the linear correlation between the reconstructed and the acoustic speech envelope.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive effort</measure>
    <time_frame>Immediately post-treatment</time_frame>
    <description>Cognitive effort is inferred from pupillometry data Growth-curve analysis will be used to determine pupil response amplitude.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Auditory Perceptual Disorders</condition>
  <condition>Age-related Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Effects of hearing aid algorithms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neural processing and cognitive effort will be assessed in individuals who listen to stimuli generated with linear and fast-acting compression hearing aid algorithms and with actual hearing aids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hearing aid amplification algorithms</intervention_name>
    <description>The investigators will use stimulus waveforms that have been amplified and recorded for each individual's hearing loss. These waveforms will be created using Desired Sensation Level, Version 5-C hearing aid targets on a continuum of increased signal manipulation. The NIH-funded open hearing aid platform will be used to provide precise control over hearing aid parameters to create waveforms with linear and fast-acting compression amplification. A third set of waveforms will be created using a current clinical hearing aid that uses typical noise reduction and compression parameters. Investigating the effects of hearing aid algorithms in young normal-hearing and older normal-hearing listeners will aid in interpretation of these effects in the older hearing-impaired listeners.</description>
    <arm_group_label>Effects of hearing aid algorithms</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aims 1 and 2 age ranges: 18-35 and 60-75&#xD;
&#xD;
          -  Aim 3 age range: 50 to 85&#xD;
&#xD;
          -  Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone&#xD;
             thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at&#xD;
             6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss&#xD;
             defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz,&#xD;
             and 60 dB HL at 4000 Hz.&#xD;
&#xD;
          -  Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15&#xD;
             dB HL at ≥ 2 frequencies.&#xD;
&#xD;
          -  Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence&#xD;
             (Psychological Corp., New York)&#xD;
&#xD;
          -  Scores ≥ 24 on the Montreal Cognitive Assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disorders&#xD;
&#xD;
          -  Middle ear pathology&#xD;
&#xD;
          -  Nonnative English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>March 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, College Park</investigator_affiliation>
    <investigator_full_name>Samira Anderson</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Presbycusis</mesh_term>
    <mesh_term>Auditory Perceptual Disorders</mesh_term>
    <mesh_term>Perceptual Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication of data and other research products shall occur during the project, if appropriate, or at the end of the project, consistent with practices in our field. De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. Research products from this project will be archived at the Digital Repository at the University of Maryland (DRUM) unless a more appropriate facility can be identified. DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse. All records in DRUM are assigned a persistent Digital Object Identifier (DOI) to support consistent discovery and citation. The project description will be automatically indexed in Google Scholar to support global discovery.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Available at the end of the project for an indefinite period.</ipd_time_frame>
    <ipd_access_criteria>For the research products available to the public, there are no conditions on reuse or redistribution beyond the attribution and credit norms of the scientific community. In the event that reviewers or researchers wish to examine data containing direct or indirect identifiers, they will be required to conform to the terms of a data use agreement. The agreement will prohibit redistribution of sensitive data.</ipd_access_criteria>
  </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/NCT04431622
org study id: 415685-15
nct id: NCT04431622
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hearing loss is a critical health concern in the rapidly aging population, affecting
      approximately 22 million older individuals in the United States. Yet, only 30% of individuals
      who would benefit from the use of hearing aids regularly use them. This project aims to
      improve the benefit of hearing aids for older adults through incorporation of objective
      neural measures to assess effects of hearing aid algorithms.
Hearing loss is among the top three major health conditions in older adults and has been
      identified as a major modifiable risk factor for dementia. It is therefore imperative that
      older adults receive effective treatment for hearing loss in a timely manner to prevent
      losses in social, emotional, and cognitive function. The current hearing aid fitting is based
      on audiometric thresholds, but this approach does not account for large individual
      differences in auditory temporal perception and cognitive ability that may affect speech
      understanding in challenging listening environments. At present, there is a gap in knowledge
      of how best to fit hearing aids for individual listeners. The long-term goal is to improve
      the benefit of hearing aids for older adults so that they can maintain independence and
      quality of life. The overall objective of this proposal is to identify the neural temporal
      processing mechanisms associated with individual differences in hearing aid benefit in older
      adults with similar audiograms. The investigators will use the innovative approach of
      combining complementary neural and behavioral measures to assess the effects of hearing aid
      amplification on speech perception and effortful listening. The central hypothesis is that
      the neural representation of the temporal envelope of speech can be used to predict hearing
      aid benefit in older adults with hearing loss. The central hypothesis will be tested through
      the pursuit of three aims: (1) Measure the extent to which amplification distorts the neural
      and perceptual processing of temporal cues; (2) Quantify reductions in temporal envelope
      tracking and increases in cognitive effort associated with amplification algorithms that
      distort the temporal envelope of the speech signal; and (3) Investigate the use of objective
      physiological measures of temporal processing to predict hearing aid benefit. The expected
      outcome is the development of an objective, neurophysiological tool for use in the design and
      fitting of advanced algorithms to maximize speech perception in a variety of listening
      environments. This outcome is expected to have a positive impact on the treatment of hearing
      loss and its sequelae in older adults, because it will lead to a better understanding of the
      neural mechanisms contributing to successful use of hearing aids.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neural response fidelity
time frame: Immediately post-treatment
description: Neuroelectric and neuromagnetic responses are recorded to amplified one-minute speech samples. Reconstruction of the speech envelope will be performed using a linear reconstruction matrix estimated via boosting. Reconstruction success is measured by the linear correlation between the reconstructed and the acoustic speech envelope.
measure: Cognitive effort
time frame: Immediately post-treatment
description: Cognitive effort is inferred from pupillometry data Growth-curve analysis will be used to determine pupil response amplitude.
arm group label: Effects of hearing aid algorithms
arm group type: Experimental
description: Neural processing and cognitive effort will be assessed in individuals who listen to stimuli generated with linear and fast-acting compression hearing aid algorithms and with actual hearing aids.
intervention type: Device
intervention name: Hearing aid amplification algorithms
description: The investigators will use stimulus waveforms that have been amplified and recorded for each individual's hearing loss. These waveforms will be created using Desired Sensation Level, Version 5-C hearing aid targets on a continuum of increased signal manipulation. The NIH-funded open hearing aid platform will be used to provide precise control over hearing aid parameters to create waveforms with linear and fast-acting compression amplification. A third set of waveforms will be created using a current clinical hearing aid that uses typical noise reduction and compression parameters. Investigating the effects of hearing aid algorithms in young normal-hearing and older normal-hearing listeners will aid in interpretation of these effects in the older hearing-impaired listeners.
arm group label: Effects of hearing aid algorithms
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, College Park
investigator full name: Samira Anderson
investigator title: Associate Professor
mesh term: Hearing Loss
mesh term: Presbycusis
mesh term: Auditory Perceptual Disorders
mesh term: Perceptual Disorders
sharing ipd: Yes
ipd description: Publication of data and other research products shall occur during the project, if appropriate, or at the end of the project, consistent with practices in our field. De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. Research products from this project will be archived at the Digital Repository at the University of Maryland (DRUM) unless a more appropriate facility can be identified. DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse. All records in DRUM are assigned a persistent Digital Object Identifier (DOI) to support consistent discovery and citation. The project description will be automatically indexed in Google Scholar to support global discovery.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Available at the end of the project for an indefinite period.
ipd access criteria: For the research products available to the public, there are no conditions on reuse or redistribution beyond the attribution and credit norms of the scientific community. In the event that reviewers or researchers wish to examine data containing direct or indirect identifiers, they will be required to conform to the terms of a data use agreement. The agreement will prohibit redistribution of sensitive data.