<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/NCT04400955</url>
  </required_header>
  <id_info>
    <org_study_id>18/SC/0057</org_study_id>
    <nct_id>NCT04400955</nct_id>
  </id_info>
  <brief_title>A Study of Web and Tablet-based Interactive Audiometry in Adults With CF</brief_title>
  <official_title>A Prospective Cross-sectional Study Analysing the Utility of Novel Tablet-based Audiometry and an Interactive Web-based Hearing App as Screening Tools for Drug-induced Ototoxicity in Adult Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</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>
      Adults with CF regularly receive anti-infective therapy that can result in impaired hearing.&#xD;
      Recent studies have identified that up to 50% of adults with CF have hearing loss with&#xD;
      resulting significant impact on quality of life. At present, however, there is no national&#xD;
      recommendation to screen for hearing loss within adult CF.&#xD;
&#xD;
      Formal hearing tests are costly, require specialist staff and equipment and require further&#xD;
      outpatient visits resulting in significant impact on health, social and financial resource.&#xD;
&#xD;
      We propose to analyse over a 12 month period at two adult cystic fibrosis centres in London&#xD;
      whether outpatient tablet based audiometry testing and web-based hearing apps are able to&#xD;
      accurately screen for ototoxicity in adults with CF, and whether these methods of screening&#xD;
      are acceptable. The results of this study will aim to streamline audiometry screening to&#xD;
      improve detection rates, reduce cost of healthcare, enable equity in service delivery, and&#xD;
      minimize disruption to the patient's social and work-life using smart technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through a prospective multi-centre cross-sectional study, the utility of outpatient&#xD;
      tablet-based audiometry (Shoebox MD, Clearwater Medical Ltd) and a novel interactive&#xD;
      web-based hearing app developed in collaboration with the Dyson School of Audio design&#xD;
      engineering, Imperial College (Project: 3D Tune-in) will be compared to standard sound-booth&#xD;
      extended high-frequency audiometry performed by an audiologist and a validated ototoxicity&#xD;
      screening questionnaire (HHIA). 200 adults with CF presenting either to the Specialist Adult&#xD;
      Cystic Fibrosis Centre at the Royal Brompton and Harefield Foundation Trust or Kings College&#xD;
      Hospital NHS Foundation Trust will be prospectively recruited to the study over a 12-month&#xD;
      period. Blood samples for genomic DNA isolation will additionally be taken for all&#xD;
      participants for mitochondrial DNA sequencing.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Tablet-based audiometry is a valid reliable tool to screen for drug-induced hearing loss in&#xD;
      adults with CF.&#xD;
&#xD;
      Blinding:&#xD;
&#xD;
      - Audiologists performing standard sound-booth extended high-frequency audiometry will be&#xD;
      blinded to results of tablet-based audiometry and web-based hearing app results.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
        -  Warble-tone thresholds will be analysed through both tablet and standard extended&#xD;
           high-frequency audiometry.&#xD;
&#xD;
        -  Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as&#xD;
           a measure of reliability.&#xD;
&#xD;
        -  Sensitivity, specificity and negative predictive value will be analysed to determine&#xD;
           utility of tablet based audiometry, web-based hearing app, standardised hearing&#xD;
           questionnaires and mitochondrial mutation screening to identify ototoxicity in adults&#xD;
           with CF.&#xD;
&#xD;
        -  Logistic regression modelling (complex statistical modelling) will be used to determine&#xD;
           risk factors for developing hearing loss within adult CF.&#xD;
&#xD;
        -  7-point Likert scale questionnaires will be used to evaluate patient satisfaction,&#xD;
           perceived usefulness and usability of tablet audiometry, web-based app hearing testing&#xD;
           and formal audiometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intraclass correlation coefficient with 95% CI</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Reliability of tablet audiometry compared to gold-standard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of audiology screening tools</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>as above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Logistic regression modeling to identify risk factors for sensorineural hearing loss in adults with CF</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>as above</description>
  </secondary_outcome>
  <enrollment type="Actual">156</enrollment>
  <condition>Hearing Loss, Sensorineural</condition>
  <condition>Cystic Fibrosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Audiometry tablet diagnostic tool and web-based test</intervention_name>
    <description>as above</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood for genomic DNA extraction&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with Cystic Fibrosis at Royal Brompton and Kings hospital London.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt;16 years old under adult cystic fibrosis unit at Royal Brompton or&#xD;
             King's college cystic fibrosis centres.&#xD;
&#xD;
        Ability to provide informed consent to participate in the study (written and witnessed).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Inability of patient to provide informed consent.&#xD;
&#xD;
               -  Patients with previously diagnosed visual impairment (due to web-based and&#xD;
                  tablet-based hearing app)&#xD;
&#xD;
               -  Established hearing loss with hearing aids in use (due to increased complexity of&#xD;
                  hearing tests required)&#xD;
&#xD;
               -  Inability to attend audiology outpatient appointments due to state of health.&#xD;
&#xD;
               -  Pregnancy (due to potential for reversible hearing loss during pregnancy&#xD;
                  affecting study reliability)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr Anand Shah</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>February 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 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>Cystic Fibrosis</mesh_term>
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study protocol and data available on request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Available on completion of study on request</ipd_time_frame>
    <ipd_access_criteria>Available on completion of study on request</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/NCT04400955
org study id: 18/SC/0057
nct id: NCT04400955
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adults with CF regularly receive anti-infective therapy that can result in impaired hearing.
      Recent studies have identified that up to 50% of adults with CF have hearing loss with
      resulting significant impact on quality of life. At present, however, there is no national
      recommendation to screen for hearing loss within adult CF.

      Formal hearing tests are costly, require specialist staff and equipment and require further
      outpatient visits resulting in significant impact on health, social and financial resource.

      We propose to analyse over a 12 month period at two adult cystic fibrosis centres in London
      whether outpatient tablet based audiometry testing and web-based hearing apps are able to
      accurately screen for ototoxicity in adults with CF, and whether these methods of screening
      are acceptable. The results of this study will aim to streamline audiometry screening to
      improve detection rates, reduce cost of healthcare, enable equity in service delivery, and
      minimize disruption to the patient's social and work-life using smart technology.
Through a prospective multi-centre cross-sectional study, the utility of outpatient
      tablet-based audiometry (Shoebox MD, Clearwater Medical Ltd) and a novel interactive
      web-based hearing app developed in collaboration with the Dyson School of Audio design
      engineering, Imperial College (Project: 3D Tune-in) will be compared to standard sound-booth
      extended high-frequency audiometry performed by an audiologist and a validated ototoxicity
      screening questionnaire (HHIA). 200 adults with CF presenting either to the Specialist Adult
      Cystic Fibrosis Centre at the Royal Brompton and Harefield Foundation Trust or Kings College
      Hospital NHS Foundation Trust will be prospectively recruited to the study over a 12-month
      period. Blood samples for genomic DNA isolation will additionally be taken for all
      participants for mitochondrial DNA sequencing.

      Hypothesis:

      Tablet-based audiometry is a valid reliable tool to screen for drug-induced hearing loss in
      adults with CF.

      Blinding:

      - Audiologists performing standard sound-booth extended high-frequency audiometry will be
      blinded to results of tablet-based audiometry and web-based hearing app results.

      Outcome measures:

        -  Warble-tone thresholds will be analysed through both tablet and standard extended
           high-frequency audiometry.

        -  Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as
           a measure of reliability.

        -  Sensitivity, specificity and negative predictive value will be analysed to determine
           utility of tablet based audiometry, web-based hearing app, standardised hearing
           questionnaires and mitochondrial mutation screening to identify ototoxicity in adults
           with CF.

        -  Logistic regression modelling (complex statistical modelling) will be used to determine
           risk factors for developing hearing loss within adult CF.

        -  7-point Likert scale questionnaires will be used to evaluate patient satisfaction,
           perceived usefulness and usability of tablet audiometry, web-based app hearing testing
           and formal audiometry.
observational model: Cohort
time perspective: Cross-Sectional
measure: Intraclass correlation coefficient with 95% CI
time frame: Through study completion, an average of 1 year
description: Reliability of tablet audiometry compared to gold-standard
measure: Sensitivity, specificity of audiology screening tools
time frame: Through study completion, an average of 1 year
description: as above
measure: Logistic regression modeling to identify risk factors for sensorineural hearing loss in adults with CF
time frame: Through study completion, an average of 1 year
description: as above
intervention type: Diagnostic Test
intervention name: Audiometry tablet diagnostic tool and web-based test
description: as above
Whole blood for genomic DNA extraction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Hearing Loss
mesh term: Hearing Loss, Sensorineural
mesh term: Fibrosis
sharing ipd: Yes
ipd description: Study protocol and data available on request.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Available on completion of study on request
ipd access criteria: Available on completion of study on request