Detecting Otoconia With CT-Scan

NCT05969340 | Withdrawn DMC

• 1 other identifier: NL 83124.068.22
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

BPPV

Keywords

BPPV; Otoconia; ultra-high resolution CT-imaging

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  up to 1 hour

Secondary Outcomes (1)

• Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.

  up to 1 hour

Study Arms (2)

Experimental group

EXPERIMENTAL

Patient diagnosed with Posterior canal BPPV

Diagnostic Test: ultra-high-resolution CT-scan

Control group

PLACEBO COMPARATOR

Patient who are scheduled for CT-imaging as part of standard clinical routine and do not have BPPV

Diagnostic Test: ultra-high-resolution CT-scan

Interventions

ultra-high-resolution CT-scan DIAGNOSTIC_TEST

Use of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experimental Group:
• Diagnosed with Posterior canal BPPV.
• Age 18 or older.
• Clear nystagmus consistent with canal direction and stimulation.
• Mild or greater complaints (none, mild, moderate, severe).
• Crescendo decrescendo nystagmus pattern.
• Slow phase eye velocity ≥ 15 deg/sec.
• Control Group:
• Scheduled for CI implantation CT scan.
• Age 18 or older.

You may not qualify if:

• Experimental Group:
• Anterior or lateral canal BPPV.
• Inability to undergo CRM and DH maneuvers.
• Central vestibular disorders.
• Multi-canal BPPV or subjective BPPV.
• Pregnancy.
• Control Group:
• BPPV, central vestibular disorders, multicanal BPPV, subjective BPPV.
• Ossifying labyrinthitis, DFNA9, obstructive vestibular schwannoma on MRI.
• Normal VHIT or history of meningitis.
• Pregnancy or other vestibular pathologies.
• Past history of BPPV.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologist assessing the CT imaging will be blinded to which participants have positive posterior canal BPPV.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Audiologist, PhD Candidate

Model Details: There are 2 groups involved: * The experimental group * The control group

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 1, 2023
• Study Start: November 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04