xml: <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/NCT06041360</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-08MS</org_study_id>
      <nct_id>NCT06041360</nct_id>
    </id_info>
    <brief_title>Prevalence of Peripheral Neuropathy Among Patients With Auditory Neuropathy</brief_title>
    <official_title>Prevalence of Peripheral Neuropathy Among Patients With Auditory Neuropathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</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>
        Auditory neuropathy/ dys-synchrony/ peri-synaptic audiopathy (AN) are terms used to describe&#xD;
        a specific hearing disorder with a disturbed auditory neural response in presence of normal&#xD;
        cochlear function. Initially reported as early as the 1970s by ( Hinchcliffe et al) after&#xD;
        observation of the patients with normal hearing thresholds, who had difficulty to detect the&#xD;
        sounds especially in presence of background noise . Auditory Neuropathy is characterized by&#xD;
        five integral features that distinguish it from other types of hearing loss. These are:&#xD;
        Variable audiometric results anywhere from normal hearing to Sensorineural hearing loss of&#xD;
        any degree up to profound hearing loss showing unusual audiometric pattern , Preserved outer&#xD;
        hair cells (OHCs) responses such as otoacoustic emissions (OAEs) and/or cochlear microphonics&#xD;
        (CM) , Altered neural processing such abnormal auditory brainstem responses (ABRs) with a&#xD;
        reduced or absent wave V , Poor speech perception with poor speech recognition score that&#xD;
        seems out of proportion compared to their pure-tone detection thresholds. , absent stapedial&#xD;
        reflexes to the ipsilateral and contralateral tone at a 110-dB hearing level .&#xD;
  &#xD;
        In 2008 it was found that AN does not represent a single disease entity but it is a&#xD;
        heterogeneous disease category with a wide range of hearing loss types ,etiologies , age and&#xD;
        clinical manifestations hence the adoption of the term auditory neuropathy spectrum disorder&#xD;
        (ANSD) by an International Newborn Hearing Screening Conference held in Italy following a&#xD;
        comprehensive study of newborn hearing test results.&#xD;
  &#xD;
        The prevalence of ANSD is variable in published studies from (0.23 to 15%) among hearing&#xD;
        impaired individuals . Regarding the underlying etiological factors, auditory neuropathy can&#xD;
        be congenital or acquired . AN without the involvement of the neurological system has been&#xD;
        termed as primary auditory neuropathy (PAN).&#xD;
  &#xD;
        Peripheral neuropathy is not a constant finding in all patients with this hearing disorder ,&#xD;
        AN may occur in the afferent pathway of acoustic nerve, probably accompanied by the&#xD;
        pathological changes of efferent nerve in the olivocochlear system inside the brainstem Our&#xD;
        study is conducted to detect the prevalence of peripheral neuropathy among patients with&#xD;
        auditory neuropathy spectrum disorder .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Measuring the prevalence of peripheral neuropathy among patients with auditory neuropathy spectrum disorder using The Michigan neuropathy screening instrument Questionnaire and Examination</measure>
      <time_frame>1 year</time_frame>
      <description>This measurement aims to determine the degree of disability on theses patients</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Auditory Neuropathy Spectrum Disorder,, Peripheral Neuropathy</condition>
    <arm_group>
      <arm_group_label>study group Study group(Group1)</arm_group_label>
      <description>Thirty participants of the group will meet the following criteria Inclusion criteria:&#xD;
  Age ranges from 12 to 50 years old.&#xD;
  Disproportionate speech recognition score (SRS) with the hearing threshold level.&#xD;
  The auditory brainstem response (ABR) test with no waveform or, disturbed waves or, detectable wave V at high intense stimulus.&#xD;
  The otoacoustic emission (OAE) and/or cochlear microphonic (CM) potential may be present.&#xD;
  Exclusion criteria:&#xD;
  While the participants who have these criteria will be excluded from the study:&#xD;
  Consistent SRS and ABR response with hearing threshold level.&#xD;
  Abnormal finding in brain imaging.&#xD;
  Patients with history of diabetes and/or other causes of peripheral neuropathy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (Group 2)</arm_group_label>
      <description>Thirty participants have the following criteria:&#xD;
  Age and sex matched with the study group.&#xD;
  Patients with sensorineural hearing loss with degree of hearing matched with study group</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pure tone audiometry PTA ,Speech audiometry ,Otoacoustic emission,Auditory evoked potentials including (ABR).</intervention_name>
      <description>Neurological tests for diagnosis of peripheral neuropathy</description>
      <arm_group_label>Control group (Group 2)</arm_group_label>
      <arm_group_label>study group Study group(Group1)</arm_group_label>
      <other_name>sural nerve conduction velocity (SNCV),sural nerve action potential (amplitude) (SNAP),vibration perception threshold (VPT),Michigan Neuropathy Screening</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Age ranges from 12 to 50 years old. Disproportionate speech recognition score (SRS) with&#xD;
          the hearing threshold level. The auditory brainstem response (ABR) test with no waveform&#xD;
          or, disturbed waves or, detectable wave V at high intense stimulus. The otoacoustic&#xD;
          emission (OAE) and/or cochlear microphonic (CM) potential may be present&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ranges from 12 to 50 years old.&#xD;
  &#xD;
            -  Disproportionate speech recognition score (SRS) with the hearing threshold level.&#xD;
  &#xD;
            -  The auditory brainstem response (ABR) test with no waveform or, disturbed waves or,&#xD;
               detectable wave V at high intense stimulus.&#xD;
  &#xD;
            -  The otoacoustic emission (OAE) and/or cochlear microphonic (CM) potential may be&#xD;
               present.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  While the participants who have these criteria will be excluded from the study:&#xD;
  &#xD;
                 -  Consistent SRS and ABR response with hearing threshold level.&#xD;
  &#xD;
                 -  Abnormal finding in brain imaging.&#xD;
  &#xD;
                 -  Patients with history of diabetes and/or other causes of peripheral neuropathy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hend A sayed, resident</last_name>
      <phone>01066935404</phone>
      <email>hendhend1995@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohamed A Abdelrahman, professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Magdy M Amin, professor</last_name>
        <email>PORTAL@MED.SOHAG.EDU.EG</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>De Siati RD, Rosenzweig F, Gersdorff G, Gregoire A, Rombaux P, Deggouj N. Auditory Neuropathy Spectrum Disorders: From Diagnosis to Treatment: Literature Review and Case Reports. J Clin Med. 2020 Apr 10;9(4):1074. doi: 10.3390/jcm9041074.</citation>
      <PMID>32290039</PMID>
    </reference>
    <reference>
      <citation>Gohari N, Emami SF, Mirbagheri SS, Valizadeh A, Abdollahi N, Borzuei M. The Prevalence and Causes of Auditory Neuropathy/Dys-synchrony (AN/AD) in Children with Hearing Impairment. Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):71-75. doi: 10.1007/s12070-018-1494-1. Epub 2018 Sep 17.</citation>
      <PMID>30906717</PMID>
    </reference>
    <reference>
      <citation>Lepcha A, Chandran RK, Alexander M, Agustine AM, Thenmozhi K, Balraj A. Neurological associations in auditory neuropathy spectrum disorder: Results from a tertiary hospital in South India. Ann Indian Acad Neurol. 2015 Apr-Jun;18(2):171-80. doi: 10.4103/0972-2327.150578.</citation>
      <PMID>26019414</PMID>
    </reference>
    <reference>
      <citation>Li JK, Li W, Gao FJ, Qu SF, Hu FY, Zhang SH, Li LL, Wang ZW, Qiu Y, Wang LS, Huang J, Wu JH, Chen F. Mutation Screening of mtDNA Combined Targeted Exon Sequencing in a Cohort With Suspected Hereditary Optic Neuropathy. Transl Vis Sci Technol. 2020 Jul 8;9(8):11. doi: 10.1167/tvst.9.8.11. eCollection 2020 Jul.</citation>
      <PMID>32855858</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Hend Abdelnasser Sayed</investigator_full_name>
      <investigator_title>Resident-Audiovestibular medicine unit of ENT department-sohag hospital university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hearing Loss, Central</mesh_term>
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041360
  org study id: Soh-Med-23-07-08MS
  nct id: NCT06041360
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Auditory neuropathy/ dys-synchrony/ peri-synaptic audiopathy (AN) are terms used to describe
        a specific hearing disorder with a disturbed auditory neural response in presence of normal
        cochlear function. Initially reported as early as the 1970s by ( Hinchcliffe et al) after
        observation of the patients with normal hearing thresholds, who had difficulty to detect the
        sounds especially in presence of background noise . Auditory Neuropathy is characterized by
        five integral features that distinguish it from other types of hearing loss. These are:
        Variable audiometric results anywhere from normal hearing to Sensorineural hearing loss of
        any degree up to profound hearing loss showing unusual audiometric pattern , Preserved outer
        hair cells (OHCs) responses such as otoacoustic emissions (OAEs) and/or cochlear microphonics
        (CM) , Altered neural processing such abnormal auditory brainstem responses (ABRs) with a
        reduced or absent wave V , Poor speech perception with poor speech recognition score that
        seems out of proportion compared to their pure-tone detection thresholds. , absent stapedial
        reflexes to the ipsilateral and contralateral tone at a 110-dB hearing level .
  
        In 2008 it was found that AN does not represent a single disease entity but it is a
        heterogeneous disease category with a wide range of hearing loss types ,etiologies , age and
        clinical manifestations hence the adoption of the term auditory neuropathy spectrum disorder
        (ANSD) by an International Newborn Hearing Screening Conference held in Italy following a
        comprehensive study of newborn hearing test results.
  
        The prevalence of ANSD is variable in published studies from (0.23 to 15%) among hearing
        impaired individuals . Regarding the underlying etiological factors, auditory neuropathy can
        be congenital or acquired . AN without the involvement of the neurological system has been
        termed as primary auditory neuropathy (PAN).
  
        Peripheral neuropathy is not a constant finding in all patients with this hearing disorder ,
        AN may occur in the afferent pathway of acoustic nerve, probably accompanied by the
        pathological changes of efferent nerve in the olivocochlear system inside the brainstem Our
        study is conducted to detect the prevalence of peripheral neuropathy among patients with
        auditory neuropathy spectrum disorder .
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Measuring the prevalence of peripheral neuropathy among patients with auditory neuropathy spectrum disorder using The Michigan neuropathy screening instrument Questionnaire and Examination
  time frame: 1 year
  description: This measurement aims to determine the degree of disability on theses patients
  arm group label: study group Study group(Group1)
  description: Thirty participants of the group will meet the following criteria Inclusion criteria:
  Age ranges from 12 to 50 years old.
  Disproportionate speech recognition score (SRS) with the hearing threshold level.
  The auditory brainstem response (ABR) test with no waveform or, disturbed waves or, detectable wave V at high intense stimulus.
  The otoacoustic emission (OAE) and/or cochlear microphonic (CM) potential may be present.
  Exclusion criteria:
  While the participants who have these criteria will be excluded from the study:
  Consistent SRS and ABR response with hearing threshold level.
  Abnormal finding in brain imaging.
  Patients with history of diabetes and/or other causes of peripheral neuropathy.
  arm group label: Control group (Group 2)
  description: Thirty participants have the following criteria:
  Age and sex matched with the study group.
  Patients with sensorineural hearing loss with degree of hearing matched with study group
  intervention type: Diagnostic Test
  intervention name: Pure tone audiometry PTA ,Speech audiometry ,Otoacoustic emission,Auditory evoked potentials including (ABR).
  description: Neurological tests for diagnosis of peripheral neuropathy
  arm group label: Control group (Group 2)
  arm group label: study group Study group(Group1)
  other name: sural nerve conduction velocity (SNCV),sural nerve action potential (amplitude) (SNAP),vibration perception threshold (VPT),Michigan Neuropathy Screening
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Hend A sayed, resident
  phone: 01066935404
  email: hendhend1995@gmail.com
  last name: Mohamed A Abdelrahman, professor
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: De Siati RD, Rosenzweig F, Gersdorff G, Gregoire A, Rombaux P, Deggouj N. Auditory Neuropathy Spectrum Disorders: From Diagnosis to Treatment: Literature Review and Case Reports. J Clin Med. 2020 Apr 10;9(4):1074. doi: 10.3390/jcm9041074.
  PMID: 32290039
  citation: Gohari N, Emami SF, Mirbagheri SS, Valizadeh A, Abdollahi N, Borzuei M. The Prevalence and Causes of Auditory Neuropathy/Dys-synchrony (AN/AD) in Children with Hearing Impairment. Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):71-75. doi: 10.1007/s12070-018-1494-1. Epub 2018 Sep 17.
  PMID: 30906717
  citation: Lepcha A, Chandran RK, Alexander M, Agustine AM, Thenmozhi K, Balraj A. Neurological associations in auditory neuropathy spectrum disorder: Results from a tertiary hospital in South India. Ann Indian Acad Neurol. 2015 Apr-Jun;18(2):171-80. doi: 10.4103/0972-2327.150578.
  PMID: 26019414
  citation: Li JK, Li W, Gao FJ, Qu SF, Hu FY, Zhang SH, Li LL, Wang ZW, Qiu Y, Wang LS, Huang J, Wu JH, Chen F. Mutation Screening of mtDNA Combined Targeted Exon Sequencing in a Cohort With Suspected Hereditary Optic Neuropathy. Transl Vis Sci Technol. 2020 Jul 8;9(8):11. doi: 10.1167/tvst.9.8.11. eCollection 2020 Jul.
  PMID: 32855858
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Hend Abdelnasser Sayed
  investigator title: Resident-Audiovestibular medicine unit of ENT department-sohag hospital university
  mesh term: Hearing Loss, Central
  mesh term: Peripheral Nervous System Diseases
  sharing ipd: Undecided