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/NCT06022471</url>
    </required_header>
    <id_info>
      <org_study_id>Outcome of ss in ot</org_study_id>
      <nct_id>NCT06022471</nct_id>
    </id_info>
    <brief_title>Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus Using Tinnitogram</brief_title>
    <acronym>Otosclerosis</acronym>
    <official_title>Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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 will be conducted on patients with otosclerosis attending Assiut University&#xD;
        Hospital and undergo stapedectomy operation Evaluation of each patient will conducted&#xD;
        preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus&#xD;
        handicap questionnaire before and after the operation to measure improvement in hearing and&#xD;
        tinnitus&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Otosclerosis is an abnormal bone remodeling in the middle ear The normal dense endochondral&#xD;
        layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone&#xD;
        leading to the fixation of the stapes.&#xD;
  &#xD;
          -  Clinical otosclerosis is more prevalent in females than in males, giving rise to the&#xD;
             hypothesis that sex hormones may contribute to the development of disease&#xD;
  &#xD;
          -  The age of onset is variable, although hearing loss typically begins in the third&#xD;
             decade, with a range from first decade to the sixth decade.&#xD;
  &#xD;
        In most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing&#xD;
        initially in one ear before progressing to the other.&#xD;
  &#xD;
        Positive family history of otosclerosis has been previously reported in between 30-70% of&#xD;
        cases.&#xD;
  &#xD;
        The diagnosis is usually made clinically by&#xD;
  &#xD;
          -  History&#xD;
  &#xD;
          -  Physical examination,&#xD;
  &#xD;
          -  Audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most&#xD;
             frequent presentation of patients with clinical otosclerosis is bilateral hearing loss&#xD;
             and tinnitus Between 65 and 87% of patient with otosclerosis experience tinnitus. most&#xD;
             of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus.&#xD;
  &#xD;
        patients with tinnitus often report that their tinnitus is associated with feelings of&#xD;
        sadness, worry, frustration, and anger.&#xD;
  &#xD;
        These feelings can lead to difficulties sleeping, relaxing, and concentrating and may&#xD;
        negatively impact relationships at work and impair participation in social settings .&#xD;
  &#xD;
        Stapedotomy through sufficient air-bone gap closure Data collection&#xD;
  &#xD;
          1. full history taking&#xD;
  &#xD;
          2. tinnitus handicap questionnaire arabic version&#xD;
  &#xD;
          3. Vital signs and general examination&#xD;
  &#xD;
          4. Full ENT examination including ear canal and tympanic membrane examination&#xD;
  &#xD;
          5. Routine audiologic testing which provide an assessment of patient hearing&#xD;
  &#xD;
          6. Investigation&#xD;
  &#xD;
          7. Preoperative fitness&#xD;
  &#xD;
          8. Tinnitogra&#xD;
  &#xD;
        Tinnitogram :&#xD;
  &#xD;
        Tinnitus pitch match : we will start at 1000 Hz and move up and down in frequency.&#xD;
  &#xD;
        Tinnitus loudness match : patient threshold was determined at frequency of pitch matching,&#xD;
        sound level will increase in small steps(1or 2 dB ) until patient repoted that specific tone&#xD;
        will just equal in loudeness to his tinnitus Tinnitus handicap questionnaire arabic version&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 15, 2024</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>decrease tinnitus</measure>
      <time_frame>3 month</time_frame>
      <description>Measuring tinnitus by tinnitogram By pure tone averages untile patients report that specific tone resemble their tinnitus The unit of measure for sound intensity is the decibel (dB)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in pure tone averages</measure>
      <time_frame>3 month</time_frame>
      <description>Pure tone averages calculated from pure tone audiometry will be summarized using the mean</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Otosclerosis</condition>
    <arm_group>
      <arm_group_label>Stapes surgery</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Stapes surgery</intervention_name>
      <description>Stapedectomy operation</description>
      <arm_group_label>Stapes surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with conductive hearing loss associated with tinnitus&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patient with otosclerosis undergo stapes surgery in otorhinology department in Assiut&#xD;
               university hospital&#xD;
  &#xD;
            -  All patient have tinnitus and conductive hearing loss or mixed hearing loss.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient with otosclerosis who don't undergo stapes surgery patient have tinnitus due&#xD;
               to causes other than otosclerosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Doaa Araby</last_name>
      <phone>01119015094</phone>
      <email>doaaaraby9@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>AssiutU Hospital</last_name>
      <phone>0882354166</phone>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Doaa Araby Mohamed</investigator_full_name>
      <investigator_title>Resident doctor at Otolaryngology Departement, Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tinnitus</mesh_term>
      <mesh_term>Otosclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06022471
  org study id: Outcome of ss in ot
  nct id: NCT06022471
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will be conducted on patients with otosclerosis attending Assiut University
        Hospital and undergo stapedectomy operation Evaluation of each patient will conducted
        preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus
        handicap questionnaire before and after the operation to measure improvement in hearing and
        tinnitus
  Otosclerosis is an abnormal bone remodeling in the middle ear The normal dense endochondral
        layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone
        leading to the fixation of the stapes.
  
          -  Clinical otosclerosis is more prevalent in females than in males, giving rise to the
             hypothesis that sex hormones may contribute to the development of disease
  
          -  The age of onset is variable, although hearing loss typically begins in the third
             decade, with a range from first decade to the sixth decade.
  
        In most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing
        initially in one ear before progressing to the other.
  
        Positive family history of otosclerosis has been previously reported in between 30-70% of
        cases.
  
        The diagnosis is usually made clinically by
  
          -  History
  
          -  Physical examination,
  
          -  Audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most
             frequent presentation of patients with clinical otosclerosis is bilateral hearing loss
             and tinnitus Between 65 and 87% of patient with otosclerosis experience tinnitus. most
             of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus.
  
        patients with tinnitus often report that their tinnitus is associated with feelings of
        sadness, worry, frustration, and anger.
  
        These feelings can lead to difficulties sleeping, relaxing, and concentrating and may
        negatively impact relationships at work and impair participation in social settings .
  
        Stapedotomy through sufficient air-bone gap closure Data collection
  
          1. full history taking
  
          2. tinnitus handicap questionnaire arabic version
  
          3. Vital signs and general examination
  
          4. Full ENT examination including ear canal and tympanic membrane examination
  
          5. Routine audiologic testing which provide an assessment of patient hearing
  
          6. Investigation
  
          7. Preoperative fitness
  
          8. Tinnitogra
  
        Tinnitogram :
  
        Tinnitus pitch match : we will start at 1000 Hz and move up and down in frequency.
  
        Tinnitus loudness match : patient threshold was determined at frequency of pitch matching,
        sound level will increase in small steps(1or 2 dB ) until patient repoted that specific tone
        will just equal in loudeness to his tinnitus Tinnitus handicap questionnaire arabic version
  observational model: Cohort
  time perspective: Prospective
  measure: decrease tinnitus
  time frame: 3 month
  description: Measuring tinnitus by tinnitogram By pure tone averages untile patients report that specific tone resemble their tinnitus The unit of measure for sound intensity is the decibel (dB)
  measure: Changes in pure tone averages
  time frame: 3 month
  description: Pure tone averages calculated from pure tone audiometry will be summarized using the mean
  arm group label: Stapes surgery
  intervention type: Procedure
  intervention name: Stapes surgery
  description: Stapedectomy operation
  arm group label: Stapes surgery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Doaa Araby
  phone: 01119015094
  email: doaaaraby9@gmail.com
  last name: AssiutU Hospital
  phone: 0882354166
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Doaa Araby Mohamed
  investigator title: Resident doctor at Otolaryngology Departement, Principal Investigator
  mesh term: Tinnitus
  mesh term: Otosclerosis
  sharing ipd: No