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/NCT05969340</url>
    </required_header>
    <id_info>
      <org_study_id>NL 83124.068.22</org_study_id>
      <nct_id>NCT05969340</nct_id>
    </id_info>
    <brief_title>Detecting Otoconia With CT-Scan</brief_title>
    <official_title>Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Ziekenhuis Maastricht</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Ziekenhuis Maastricht</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>
        Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the&#xD;
        patient to experience short episodes of vertigo when there are changes in head position. The&#xD;
        current theory on the causes of BPPV is the displacement of the otoconia from the otolith&#xD;
        organ to the semicircular canal organs. BPPV's current treatments consist of repositioning&#xD;
        maneuvers to readjust the location of the otoconia back to its original place. Even though&#xD;
        the treatments are highly successful in many cases, this study, if proven successful, will&#xD;
        help confirm this theory and will help diagnose complicated cases where BPPV is recurrent and&#xD;
        treatment has been unsuccessful.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the&#xD;
        patient to experience vertigo when there are changes in head position. The prevalence is&#xD;
        estimated to account for 20-30% of all vertigo diagnoses in a specialized clinic (von Brevern&#xD;
        et al., 2007). The current theory on the cause of BPPV is the displacement of otoconia from&#xD;
        the otolith organ to the semicircular canal organs due to gravitational forces.&#xD;
  &#xD;
        Current treatments for BPPV consist of repositioning maneuvers to readjust the location of&#xD;
        the otoconia back to its original place (von Brevern et al., 2015). Even though the treatment&#xD;
        is highly successful in many cases patients still have recurrent (26%) or persistent (4%)&#xD;
        symptoms (Dorigueto et al., 2009), and objective confirmation of the disease is warranted.&#xD;
        Until now, visualization and confirmation of the presence of otoliths have not been&#xD;
        successful in clinical practice. This is largely due to the very small size of the otoliths&#xD;
        in a small inner ear structure, requiring sensitive and ultra-high-resolution imaging.&#xD;
  &#xD;
        In 2021, a study was performed in Japan using 3 Dimensional Computed Tomography (3D CT) scans&#xD;
        to detect the otoconia inside the horizontal canal. It compared scans of people with BPPV in&#xD;
        the horizontal canal and healthy individuals (Yamane et al., 2021). The authors were able to&#xD;
        visualize otoconia-like substance inside the canal in all 10 out of 10 affected patients and&#xD;
        6 out of 10 of the healthy participants in at least one ear (Yamane et al., 2021). In this&#xD;
        study, the investigators will image the patients temporal bone with an ultra-high-resolution&#xD;
        CT-scan (Benson et al.2022). They will focus on imaging the posterior canal for BPPV, and&#xD;
        compare it with the imaging of individuals who do not have BPPV. In addition, they will&#xD;
        compare the imaging of the canal pre and post-treatment using the Epley maneuver.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>There are 2 groups involved:&#xD;
  The experimental group&#xD;
  The control group</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The radiologist assessing the CT imaging will be blinded to which participants have positive posterior canal BPPV.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visualisation of presence or absence of otoconia in the posterior semicircular canal by comparing patient with confirmed BPPV symptoms compared to control subjects without BPPV</measure>
      <time_frame>up to 1 hour</time_frame>
      <description>The presence or absence of otoconia in the posterior semicircular canal will be assessed qualitatively and semi-quantitatively using the CT parameters for BPPV patients, and the radiological images will be compared to those of control subjects.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.</measure>
      <time_frame>up to 1 hour</time_frame>
      <description>Change in position of the otoconia will be assessed qualitatively and semi-quantitively using the CT parameters in BPPV patients by comparing the radiological images before and after repositioning maneuver (Epley)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>BPPV</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient diagnosed with Posterior canal BPPV</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patient who are scheduled for CT-imaging as part of standard clinical routine and do not have BPPV</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>ultra-high-resolution CT-scan</intervention_name>
      <description>Use of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Experimental Group:&#xD;
  &#xD;
            -  Diagnosed with Posterior canal BPPV.&#xD;
  &#xD;
            -  Age 18 or older.&#xD;
  &#xD;
            -  Clear nystagmus consistent with canal direction and stimulation.&#xD;
  &#xD;
            -  Mild or greater complaints (none, mild, moderate, severe).&#xD;
  &#xD;
            -  Crescendo decrescendo nystagmus pattern.&#xD;
  &#xD;
            -  Slow phase eye velocity ≥ 15 deg/sec.&#xD;
  &#xD;
          Control Group:&#xD;
  &#xD;
            -  Scheduled for CI implantation CT scan.&#xD;
  &#xD;
            -  Age 18 or older.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Experimental Group:&#xD;
  &#xD;
            -  Anterior or lateral canal BPPV.&#xD;
  &#xD;
            -  Inability to undergo CRM and DH maneuvers.&#xD;
  &#xD;
            -  Central vestibular disorders.&#xD;
  &#xD;
            -  Multi-canal BPPV or subjective BPPV.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
          Control Group:&#xD;
  &#xD;
            -  BPPV, central vestibular disorders, multicanal BPPV, subjective BPPV.&#xD;
  &#xD;
            -  Ossifying labyrinthitis, DFNA9, obstructive vestibular schwannoma on MRI.&#xD;
  &#xD;
            -  Normal VHIT or history of meningitis.&#xD;
  &#xD;
            -  Pregnancy or other vestibular pathologies.&#xD;
  &#xD;
            -  Past history of BPPV.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ali Melliti, Au.D.</last_name>
      <phone>+31657967995</phone>
      <email>ali.melliti@mumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Raymond van de Berg, M.D.</last_name>
      <email>raymond.vande.berg@mumc.nl</email>
    </overall_contact_backup>
    <reference>
      <citation>von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.</citation>
      <PMID>17135456</PMID>
    </reference>
    <reference>
      <citation>von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553.</citation>
      <PMID>26756126</PMID>
    </reference>
    <reference>
      <citation>Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol. 2009 Jul-Aug;75(4):565-72. doi: 10.1016/s1808-8694(15)30497-3.</citation>
      <PMID>19784427</PMID>
    </reference>
    <reference>
      <citation>Yamane H, Konishi K, Anniko M. Visualization of horizontal canal benign paroxysmal positional vertigo using 3DCT imaging and its assessment. Acta Otolaryngol. 2021 May;141(5):482-489. doi: 10.1080/00016489.2021.1892822. Epub 2021 Mar 29.</citation>
      <PMID>33781168</PMID>
    </reference>
    <reference>
      <citation>Rajendran K, Voss BA, Zhou W, Tao S, DeLone DR, Lane JI, Weaver JM, Carlson ML, Fletcher JG, McCollough CH, Leng S. Dose Reduction for Sinus and Temporal Bone Imaging Using Photon-Counting Detector CT With an Additional Tin Filter. Invest Radiol. 2020 Feb;55(2):91-100. doi: 10.1097/RLI.0000000000000614.</citation>
      <PMID>31770297</PMID>
    </reference>
    <reference>
      <citation>Benson JC, Rajendran K, Lane JI, Diehn FE, Weber NM, Thorne JE, Larson NB, Fletcher JG, McCollough CH, Leng S. A New Frontier in Temporal Bone Imaging: Photon-Counting Detector CT Demonstrates Superior Visualization of Critical Anatomic Structures at Reduced Radiation Dose. AJNR Am J Neuroradiol. 2022 Apr;43(4):579-584. doi: 10.3174/ajnr.A7452. Epub 2022 Mar 24.</citation>
      <PMID>35332019</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Ziekenhuis Maastricht</investigator_affiliation>
      <investigator_full_name>Ali Melliti</investigator_full_name>
      <investigator_title>Audiologist, PhD Candidate</investigator_title>
    </responsible_party>
    <keyword>BPPV</keyword>
    <keyword>Otoconia</keyword>
    <keyword>ultra-high resolution CT-imaging</keyword>
    <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/NCT05969340
  org study id: NL 83124.068.22
  nct id: NCT05969340
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the
        patient to experience short episodes of vertigo when there are changes in head position. The
        current theory on the causes of BPPV is the displacement of the otoconia from the otolith
        organ to the semicircular canal organs. BPPV's current treatments consist of repositioning
        maneuvers to readjust the location of the otoconia back to its original place. Even though
        the treatments are highly successful in many cases, this study, if proven successful, will
        help confirm this theory and will help diagnose complicated cases where BPPV is recurrent and
        treatment has been unsuccessful.
  Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the
        patient to experience vertigo when there are changes in head position. The prevalence is
        estimated to account for 20-30% of all vertigo diagnoses in a specialized clinic (von Brevern
        et al., 2007). The current theory on the cause of BPPV is the displacement of otoconia from
        the otolith organ to the semicircular canal organs due to gravitational forces.
  
        Current treatments for BPPV consist of repositioning maneuvers to readjust the location of
        the otoconia back to its original place (von Brevern et al., 2015). Even though the treatment
        is highly successful in many cases patients still have recurrent (26%) or persistent (4%)
        symptoms (Dorigueto et al., 2009), and objective confirmation of the disease is warranted.
        Until now, visualization and confirmation of the presence of otoliths have not been
        successful in clinical practice. This is largely due to the very small size of the otoliths
        in a small inner ear structure, requiring sensitive and ultra-high-resolution imaging.
  
        In 2021, a study was performed in Japan using 3 Dimensional Computed Tomography (3D CT) scans
        to detect the otoconia inside the horizontal canal. It compared scans of people with BPPV in
        the horizontal canal and healthy individuals (Yamane et al., 2021). The authors were able to
        visualize otoconia-like substance inside the canal in all 10 out of 10 affected patients and
        6 out of 10 of the healthy participants in at least one ear (Yamane et al., 2021). In this
        study, the investigators will image the patients temporal bone with an ultra-high-resolution
        CT-scan (Benson et al.2022). They will focus on imaging the posterior canal for BPPV, and
        compare it with the imaging of individuals who do not have BPPV. In addition, they will
        compare the imaging of the canal pre and post-treatment using the Epley maneuver.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: There are 2 groups involved:
  The experimental group
  The control group
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  masking description: The radiologist assessing the CT imaging will be blinded to which participants have positive posterior canal BPPV.
  measure: Visualisation of presence or absence of otoconia in the posterior semicircular canal by comparing patient with confirmed BPPV symptoms compared to control subjects without BPPV
  time frame: up to 1 hour
  description: The presence or absence of otoconia in the posterior semicircular canal will be assessed qualitatively and semi-quantitatively using the CT parameters for BPPV patients, and the radiological images will be compared to those of control subjects.
  measure: Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.
  time frame: up to 1 hour
  description: Change in position of the otoconia will be assessed qualitatively and semi-quantitively using the CT parameters in BPPV patients by comparing the radiological images before and after repositioning maneuver (Epley)
  arm group label: Experimental group
  arm group type: Experimental
  description: Patient diagnosed with Posterior canal BPPV
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Patient who are scheduled for CT-imaging as part of standard clinical routine and do not have BPPV
  intervention type: Diagnostic Test
  intervention name: ultra-high-resolution CT-scan
  description: Use of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV
  arm group label: Control group
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ali Melliti, Au.D.
  phone: +31657967995
  email: ali.melliti@mumc.nl
  last name: Raymond van de Berg, M.D.
  email: raymond.vande.berg@mumc.nl
  citation: von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
  PMID: 17135456
  citation: von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553.
  PMID: 26756126
  citation: Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol. 2009 Jul-Aug;75(4):565-72. doi: 10.1016/s1808-8694(15)30497-3.
  PMID: 19784427
  citation: Yamane H, Konishi K, Anniko M. Visualization of horizontal canal benign paroxysmal positional vertigo using 3DCT imaging and its assessment. Acta Otolaryngol. 2021 May;141(5):482-489. doi: 10.1080/00016489.2021.1892822. Epub 2021 Mar 29.
  PMID: 33781168
  citation: Rajendran K, Voss BA, Zhou W, Tao S, DeLone DR, Lane JI, Weaver JM, Carlson ML, Fletcher JG, McCollough CH, Leng S. Dose Reduction for Sinus and Temporal Bone Imaging Using Photon-Counting Detector CT With an Additional Tin Filter. Invest Radiol. 2020 Feb;55(2):91-100. doi: 10.1097/RLI.0000000000000614.
  PMID: 31770297
  citation: Benson JC, Rajendran K, Lane JI, Diehn FE, Weber NM, Thorne JE, Larson NB, Fletcher JG, McCollough CH, Leng S. A New Frontier in Temporal Bone Imaging: Photon-Counting Detector CT Demonstrates Superior Visualization of Critical Anatomic Structures at Reduced Radiation Dose. AJNR Am J Neuroradiol. 2022 Apr;43(4):579-584. doi: 10.3174/ajnr.A7452. Epub 2022 Mar 24.
  PMID: 35332019
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Ziekenhuis Maastricht
  investigator full name: Ali Melliti
  investigator title: Audiologist, PhD Candidate
  sharing ipd: Undecided