<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/NCT03279367</url>
  </required_header>
  <id_info>
    <org_study_id>30123</org_study_id>
    <nct_id>NCT03279367</nct_id>
  </id_info>
  <brief_title>Optimisation of Hearing Aid Fitting</brief_title>
  <official_title>Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Berkshire NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Engineering and Physical Sciences Research Council, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southampton</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore if objective brain responses to speech stimuli (words and running&#xD;
      speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses&#xD;
      would be beneficial, as they could be used to evaluate hearing with people who are incapable&#xD;
      or unwilling to provide subjective responses. The study aims to determine if EEG responses to&#xD;
      speech sounds are sensitive to the effects of hearing aids for hearing aid users. Secondary,&#xD;
      the study will look into the need for using speech stimuli in order to obtain more robust&#xD;
      responses compared to current clinical standards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research questions addressed are as follows&#xD;
&#xD;
        1. Are speech-evoked objective brain responses sensitive to hearing aid amplification?&#xD;
&#xD;
        2. Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid&#xD;
           amplification resolve issues with brain responses to distorted speech?&#xD;
&#xD;
        3. Which tests are optimal for detection of objective brain responses to speech?&#xD;
&#xD;
        4. Are realistic speech stimuli (words or running speech) able to robustly detect brain&#xD;
           responses compared to current clinical standards (clicks and tones)? The study will be&#xD;
           carried out on a group of mildly to moderately hearing impaired subjects between the age&#xD;
           of 18 and 70. Subjects will be recruited from the Royal Berkshire NHS Foundation Trust,&#xD;
           where the research will be conducted. Participants will have their hearing function and&#xD;
           hearing aid fitting checked as described in the design and methodology section of this&#xD;
           proposal. During the experiment, participants will be asked to listen to speech sounds&#xD;
           presented from a loudspeaker at comfortable listening levels. The responses will be&#xD;
           measured with the participant wearing and not wearing hearing aids. Additionally,&#xD;
           participants will perform a behavioural task for perception of speech. Participants will&#xD;
           be asked to attend 2 sessions of 2 hours. Data collection will run over 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response detection</measure>
    <time_frame>Immediate</time_frame>
    <description>Detection success rate and time for obtaining a brain response to the sound stimuli.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved statistical test</measure>
    <time_frame>Immediate</time_frame>
    <description>Hotelling's T2 test to objectively determine the presence of a response compared to background noise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stimulus reconstruction</measure>
    <time_frame>Immediate</time_frame>
    <description>Correlation test to determine the accuracy of the estimated speech stimulus using the decoder compared to the presented speech stimulus for running speech.&#xD;
Detection of auditory brainstem and auditory steady state potential characteristic peaks and troughs for responses to click and tone stimuli, respectively.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Hearing Loss</condition>
  <condition>Hearing Abnormality</condition>
  <arm_group>
    <arm_group_label>Hearing Impaired</arm_group_label>
    <description>Participants will be asked to wear an electro-encephalography (EEG) cap for measurement of brain activity whilst listening to speech stimuli. The speech stimuli will be presented through a loudspeaker positioned 1 meter in front of the participant. Participants will be asked to listen to the speech stimuli when using and without using their hearing aid. They will be asked to pay attention to the speech stimuli. This will be assured by asking them to answer questions related to the speech stimulus at random intervals. Subjects will also go through standard clinical procedures for assessing their hearing function and hearing aid setup.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Objective speech response detection</intervention_name>
    <description>Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)</description>
    <arm_group_label>Hearing Impaired</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be included if they are between 18 and 70 years old, are native English&#xD;
        speakers and have mild to moderate hearing loss in their better ear measured using current&#xD;
        clinical standards. They will be identified from their medical records of the Royal&#xD;
        Berkshire NHS Foundation Trust by the Co-Investigators who are trained and qualified&#xD;
        clinical audiologists at the Trust. Subjects will be routine hearing aid users.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects are between 18 and 70 years old&#xD;
&#xD;
          -  Native English speakers&#xD;
&#xD;
          -  Have mild to moderate hearing loss in their better ear measured using current clinical&#xD;
             standards&#xD;
&#xD;
          -  Routine hearing aid users&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical observation indicates the presence of ear infections or an occluded ear canal&#xD;
             on the day of testing&#xD;
&#xD;
          -  Subjects with recent ear surgery (within a month before the day of testing)&#xD;
&#xD;
          -  Subjects who are taking substances that could affect brain responses (e.g. medication&#xD;
             for the treatment of depression)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven L Bell, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG15LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Vanheusden FJ, Kegler M, Ireland K, Georga C, Simpson DM, Reichenbach T, Bell SL. Hearing Aids Do Not Alter Cortical Entrainment to Speech at Audible Levels in Mild-to-Moderately Hearing-Impaired Subjects. Front Hum Neurosci. 2020 Apr 3;14:109. doi: 10.3389/fnhum.2020.00109. eCollection 2020.</citation>
    <PMID>32317951</PMID>
  </results_reference>
  <results_reference>
    <citation>Vanheusden FJ, Chesnaye MA, Simpson DM, Bell SL. Envelope frequency following responses are stronger for high-pass than low-pass filtered vowels. Int J Audiol. 2019 Jun;58(6):355-362. doi: 10.1080/14992027.2018.1562243. Epub 2019 Jan 24.</citation>
    <PMID>30675827</PMID>
  </results_reference>
  <results_reference>
    <citation>Vanheusden FJ, Bell SL, Chesnaye MA, Simpson DM. Improved Detection of Vowel Envelope Frequency Following Responses Using Hotelling's T2 Analysis. Ear Hear. 2019 Jan/Feb;40(1):116-127. doi: 10.1097/AUD.0000000000000598.</citation>
    <PMID>29757799</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>July 24, 2021</last_update_submitted>
  <last_update_submitted_qc>July 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hearing Loss</keyword>
  <keyword>Hearing Abnormality</keyword>
  <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>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Anonymised data will be collected and stored in Pure/ePrints at the University of Southampton along with a metadata file describing the procedure and providing participant demographics such as age and gender. Anonymised data will also be stored on password-protected University computers and backed up on password-protected hard drives. Anonymised data will be kept available for public access (for research and teaching purposes) under guidelines of the University of Southampton for at least 10 years. Clear information regarding the storage and possible reuse of anonymized data will be given to the participant prior to the experiment. Participants will have the possibility to opt out of this data sharing policy.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03279367/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03279367/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03279367
org study id: 30123
nct id: NCT03279367
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to explore if objective brain responses to speech stimuli (words and running
      speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses
      would be beneficial, as they could be used to evaluate hearing with people who are incapable
      or unwilling to provide subjective responses. The study aims to determine if EEG responses to
      speech sounds are sensitive to the effects of hearing aids for hearing aid users. Secondary,
      the study will look into the need for using speech stimuli in order to obtain more robust
      responses compared to current clinical standards.
The research questions addressed are as follows

        1. Are speech-evoked objective brain responses sensitive to hearing aid amplification?

        2. Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid
           amplification resolve issues with brain responses to distorted speech?

        3. Which tests are optimal for detection of objective brain responses to speech?

        4. Are realistic speech stimuli (words or running speech) able to robustly detect brain
           responses compared to current clinical standards (clicks and tones)? The study will be
           carried out on a group of mildly to moderately hearing impaired subjects between the age
           of 18 and 70. Subjects will be recruited from the Royal Berkshire NHS Foundation Trust,
           where the research will be conducted. Participants will have their hearing function and
           hearing aid fitting checked as described in the design and methodology section of this
           proposal. During the experiment, participants will be asked to listen to speech sounds
           presented from a loudspeaker at comfortable listening levels. The responses will be
           measured with the participant wearing and not wearing hearing aids. Additionally,
           participants will perform a behavioural task for perception of speech. Participants will
           be asked to attend 2 sessions of 2 hours. Data collection will run over 1 year.
observational model: Cohort
time perspective: Prospective
measure: Objective response detection
time frame: Immediate
description: Detection success rate and time for obtaining a brain response to the sound stimuli.
measure: Improved statistical test
time frame: Immediate
description: Hotelling's T2 test to objectively determine the presence of a response compared to background noise.
measure: Stimulus reconstruction
time frame: Immediate
description: Correlation test to determine the accuracy of the estimated speech stimulus using the decoder compared to the presented speech stimulus for running speech.
Detection of auditory brainstem and auditory steady state potential characteristic peaks and troughs for responses to click and tone stimuli, respectively.
arm group label: Hearing Impaired
description: Participants will be asked to wear an electro-encephalography (EEG) cap for measurement of brain activity whilst listening to speech stimuli. The speech stimuli will be presented through a loudspeaker positioned 1 meter in front of the participant. Participants will be asked to listen to the speech stimuli when using and without using their hearing aid. They will be asked to pay attention to the speech stimuli. This will be assured by asking them to answer questions related to the speech stimulus at random intervals. Subjects will also go through standard clinical procedures for assessing their hearing function and hearing aid setup.
intervention type: Diagnostic Test
intervention name: Objective speech response detection
description: Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)
arm group label: Hearing Impaired
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Steven L Bell, Dr
role: Principal Investigator
affiliation: University of Southampton
facility: 
country: United Kingdom
citation: Vanheusden FJ, Kegler M, Ireland K, Georga C, Simpson DM, Reichenbach T, Bell SL. Hearing Aids Do Not Alter Cortical Entrainment to Speech at Audible Levels in Mild-to-Moderately Hearing-Impaired Subjects. Front Hum Neurosci. 2020 Apr 3;14:109. doi: 10.3389/fnhum.2020.00109. eCollection 2020.
PMID: 32317951
citation: Vanheusden FJ, Chesnaye MA, Simpson DM, Bell SL. Envelope frequency following responses are stronger for high-pass than low-pass filtered vowels. Int J Audiol. 2019 Jun;58(6):355-362. doi: 10.1080/14992027.2018.1562243. Epub 2019 Jan 24.
PMID: 30675827
citation: Vanheusden FJ, Bell SL, Chesnaye MA, Simpson DM. Improved Detection of Vowel Envelope Frequency Following Responses Using Hotelling's T2 Analysis. Ear Hear. 2019 Jan/Feb;40(1):116-127. doi: 10.1097/AUD.0000000000000598.
PMID: 29757799
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Congenital Abnormalities
sharing ipd: No
ipd description: Anonymised data will be collected and stored in Pure/ePrints at the University of Southampton along with a metadata file describing the procedure and providing participant demographics such as age and gender. Anonymised data will also be stored on password-protected University computers and backed up on password-protected hard drives. Anonymised data will be kept available for public access (for research and teaching purposes) under guidelines of the University of Southampton for at least 10 years. Clear information regarding the storage and possible reuse of anonymized data will be given to the participant prior to the experiment. Participants will have the possibility to opt out of this data sharing policy.
provided document: 
provided document: 