<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/NCT03252392</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17200055</org_study_id>
    <nct_id>NCT03252392</nct_id>
  </id_info>
  <brief_title>/Autism Spectrum Disorder(ASD)Hearing Abnormalities Study</brief_title>
  <official_title>Does Autism Spectrum Disorder(ASD)Show Any Degree of Hearing Abnormalities? :A Preliminary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Co morbidity rates of hearing loss in children with autism spectrum disorder are high and&#xD;
      increasing.&#xD;
&#xD;
      Investigators are aiming to:&#xD;
&#xD;
        1. evaluate peripheral auditory and brain stem auditory function in children with autism&#xD;
           spectrum disorder.&#xD;
&#xD;
        2. compare communication capabilities in autistic children having hearing abnormalities and&#xD;
           autistic children with normal hearing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Full audiological evaluation is carried out to all participants including:&#xD;
&#xD;
        -  pure tone and speech audiometry.&#xD;
&#xD;
        -  Tympanometry and acoustic reflex threshold evaluation.&#xD;
&#xD;
        -  Threshold auditory brain stem response for threshold determination in non co operative&#xD;
           children not respond to pure tone,speech audiometry.&#xD;
&#xD;
        -  Auditory brain stem response for neuro-otologic diagnosis.&#xD;
&#xD;
        -  Transient evoked otoacoustic emissions in children proved to have normal hearing to&#xD;
           detect minimal cochlear affection .&#xD;
&#xD;
        -  Transient evoked otoacoustic emissions with contralateral masking. Communication&#xD;
           evaluation is carried out to all participants using arabic language test(kotby et&#xD;
           al,1995).&#xD;
&#xD;
      Investigators use childhood autism rating scale for (CARS) for diagnosis of autism spectrum&#xD;
      disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of autistic participants suffering from hearing abnormalities.</measure>
    <time_frame>3 years from october 2017 to october 2020</time_frame>
    <description>Invistigators choose autistic children attending phoniatric unit in assiut university from october 2017 to october 2020 as they will go under complete audiological evaluation.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>children with autism spectrum disorder</arm_group_label>
    <description>Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy non autistic age matched volunteers</arm_group_label>
    <description>children aged 3-12 years old never diagnosed to have autism spectrum disorder</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        children aged 3-12 years old attending phoniatric unit of assiut university from october&#xD;
        2017 t0 october 2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder&#xD;
             diagnosed by childhood autism spectrum disorder(CARS 35% or less)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with otitis media with effusion.&#xD;
&#xD;
          -  Associated neurological deficit .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>weaam noaman mohamed</investigator_full_name>
    <investigator_title>Principal invistigator</investigator_title>
  </responsible_party>
  <keyword>hearing and communication abnormalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De identified IPD for all primary and secondary out come measures will be made available.</ipd_description>
    <ipd_time_frame>6 months after publication</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external independent review panel,Requesters will be required to sign a data access agreement</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/NCT03252392
org study id: IRB17200055
nct id: NCT03252392
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Co morbidity rates of hearing loss in children with autism spectrum disorder are high and
      increasing.

      Investigators are aiming to:

        1. evaluate peripheral auditory and brain stem auditory function in children with autism
           spectrum disorder.

        2. compare communication capabilities in autistic children having hearing abnormalities and
           autistic children with normal hearing.
Full audiological evaluation is carried out to all participants including:

        -  pure tone and speech audiometry.

        -  Tympanometry and acoustic reflex threshold evaluation.

        -  Threshold auditory brain stem response for threshold determination in non co operative
           children not respond to pure tone,speech audiometry.

        -  Auditory brain stem response for neuro-otologic diagnosis.

        -  Transient evoked otoacoustic emissions in children proved to have normal hearing to
           detect minimal cochlear affection .

        -  Transient evoked otoacoustic emissions with contralateral masking. Communication
           evaluation is carried out to all participants using arabic language test(kotby et
           al,1995).

      Investigators use childhood autism rating scale for (CARS) for diagnosis of autism spectrum
      disorder.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Number of autistic participants suffering from hearing abnormalities.
time frame: 3 years from october 2017 to october 2020
description: Invistigators choose autistic children attending phoniatric unit in assiut university from october 2017 to october 2020 as they will go under complete audiological evaluation.
arm group label: children with autism spectrum disorder
description: Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)
arm group label: healthy non autistic age matched volunteers
description: children aged 3-12 years old never diagnosed to have autism spectrum disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: weaam noaman mohamed
investigator title: Principal invistigator
mesh term: Congenital Abnormalities
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: Yes
ipd description: De identified IPD for all primary and secondary out come measures will be made available.
ipd time frame: 6 months after publication
ipd access criteria: Data access requests will be reviewed by an external independent review panel,Requesters will be required to sign a data access agreement