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/NCT05999461</url>
    </required_header>
    <id_info>
      <org_study_id>behcet disease</org_study_id>
      <nct_id>NCT05999461</nct_id>
    </id_info>
    <brief_title>Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease</brief_title>
    <official_title>Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease</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>
        Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular&#xD;
        abnormalities as well as cochlear function affection have been found. The inflammatory&#xD;
        process in BD may be the cause of audiometry abnormalities in those patients. The aim of this&#xD;
        study is to assess hearing dysfunction in Behçet patients and its relation to retinal&#xD;
        ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and&#xD;
        acoustic reflex&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        pure tone audiometry is a behavioral test used to measure hearing sensitivity. This measure&#xD;
        involves the peripheral and central auditory systems. Pure-tone thresholds (PTTs) indicate&#xD;
        the softest sound audible to an individual at least 50% of the time. Hearing sensitivity is&#xD;
        plotted on an audiogram, which displays intensity as a function of frequency.&#xD;
  &#xD;
        Speech audiometry employs speech signals to assess if the patient has problems hearing speech&#xD;
        or speech in noise. Speech audiometry can be used to examine the processing ability and if it&#xD;
        is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or&#xD;
        auditory centers of the cortex.&#xD;
  &#xD;
        Tympanogram is a test of middle ear functioning. This objective test also allows to view the&#xD;
        functioning of the Eustachian Tube, the upper auditory pathways and the reflex contraction&#xD;
        from the middle ear muscles. Impedance testing is crucial in distinguishing a conductive loss&#xD;
        from a sensorineural hearing loss.&#xD;
  &#xD;
        Optical coherence tomography angiography (OCT-A) for imaging the microvasculature of the&#xD;
        retina and the choroid.&#xD;
  &#xD;
        Behcet disease current activity form for assessment of disease activity range from 0 to 12 .&#xD;
        12 represents the highest disease activity. It depends on the symptoms present over the last&#xD;
        4 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 2, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Detection of hearing abnormalities in behcet disease</measure>
      <time_frame>3 MONTHS</time_frame>
      <description>pure tone audiometry, tympanogram and acoustic reflex</description>
    </primary_outcome>
    <primary_outcome>
      <measure>correlation of hearing abnormalities with retinal ischemia</measure>
      <time_frame>3 months</time_frame>
      <description>oct angiography</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Behcet's Disease With Multisystem Involvement</condition>
    <arm_group>
      <arm_group_label>cases</arm_group_label>
      <description>behcet patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <description>age and sex matched healthy volunteers</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study subjects consist of 2 groups. the first group is behcet patients that fulfill the&#xD;
          International Criteria of behcet disease. second group consists of age and sex matched&#xD;
          healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients fulfill the International Criteria of behcet disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age more than 50&#xD;
  &#xD;
            -  ear infection,&#xD;
  &#xD;
            -  ear trauma, acoustic trauma, or usage of ototoxic drugs.&#xD;
  &#xD;
            -  Also, associated systemic diseases that can affect the hearing as infectious diseases&#xD;
               (e.g., mumps, CMV), granulomatous diseases (e.g., sarcoidosis, Wegner's&#xD;
               granulomatosis), other autoimmune diseases (e.g., Rheumatoid arthritis, Cogan's&#xD;
               syndrome, polyarteritis nodosa, relapsing polychondritis), and diseases of the bone&#xD;
               (e.g., Paget's disease).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Maha Abdelrahman, PHD</last_name>
      <phone>01111212050</phone>
      <email>mahasayed@aun.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Assiut University Hospital</name>
        <address>
          <city>Assiut</city>
          <zip>71515</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>MAHA Abdelrahman, PHD</last_name>
        <phone>01011212050</phone>
        <email>mahasayed@aun.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 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>Assiut University</investigator_affiliation>
      <investigator_full_name>Maha Sayed Ibrahim Abdelrahman</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Behcet Syndrome</mesh_term>
      <mesh_term>Hearing Disorders</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT05999461
  org study id: behcet disease
  nct id: NCT05999461
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular
        abnormalities as well as cochlear function affection have been found. The inflammatory
        process in BD may be the cause of audiometry abnormalities in those patients. The aim of this
        study is to assess hearing dysfunction in Behçet patients and its relation to retinal
        ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and
        acoustic reflex
  pure tone audiometry is a behavioral test used to measure hearing sensitivity. This measure
        involves the peripheral and central auditory systems. Pure-tone thresholds (PTTs) indicate
        the softest sound audible to an individual at least 50% of the time. Hearing sensitivity is
        plotted on an audiogram, which displays intensity as a function of frequency.
  
        Speech audiometry employs speech signals to assess if the patient has problems hearing speech
        or speech in noise. Speech audiometry can be used to examine the processing ability and if it
        is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or
        auditory centers of the cortex.
  
        Tympanogram is a test of middle ear functioning. This objective test also allows to view the
        functioning of the Eustachian Tube, the upper auditory pathways and the reflex contraction
        from the middle ear muscles. Impedance testing is crucial in distinguishing a conductive loss
        from a sensorineural hearing loss.
  
        Optical coherence tomography angiography (OCT-A) for imaging the microvasculature of the
        retina and the choroid.
  
        Behcet disease current activity form for assessment of disease activity range from 0 to 12 .
        12 represents the highest disease activity. It depends on the symptoms present over the last
        4 weeks.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Detection of hearing abnormalities in behcet disease
  time frame: 3 MONTHS
  description: pure tone audiometry, tympanogram and acoustic reflex
  measure: correlation of hearing abnormalities with retinal ischemia
  time frame: 3 months
  description: oct angiography
  arm group label: cases
  description: behcet patients
  arm group label: control
  description: age and sex matched healthy volunteers
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maha Abdelrahman, PHD
  phone: 01111212050
  email: mahasayed@aun.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Maha Sayed Ibrahim Abdelrahman
  investigator title: Principal investigator
  mesh term: Behcet Syndrome
  mesh term: Hearing Disorders
  mesh term: Ischemia