Detecting Otoconia With CT-Scan

Sponsor
Academisch Ziekenhuis Maastricht (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05969340
Collaborator
(none)
26
2
16

Study Details

Study Description

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 confirm this theory and will help diagnose complicated cases where BPPV is recurrent and treatment has been unsuccessful.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultra-high-resolution CT-scan
N/A

Detailed Description

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, referred to as canalithiasis. These microstructures stimulate the vestibular organ without any head movement, resulting in vertigo (von Brevern et al., 2015).

The diagnosis of BPPV relies on history taking and positional tests. Treatment with particle repositioning maneuvers can be performed immediately following the positional test.

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, a significant number of patients still have recurrent (27%) or persistent 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 otoconias inside the canal in all affected patients and three of the healthy participants (Yamane et al., 2021). In this study, the investigators will image the patients with a CT with an ultra-high-resolution scanning with concomitant spectral imaging. They will focus on imaging the posterior canal BPPV as it represents the most affected canal in BPPV and compare the imaging of the canal pre and post-treatment using the Epley maneuver as the most effective repositioning maneuver (Bruintjes et al., 2014; von Brevern et al., 2015).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are 2 groups involved: The experimental group The control groupThere are 2 groups involved:The experimental group The control group
Masking:
Single (Outcomes Assessor)
Masking Description:
The radiologist assessing the CT imaging will be blinded to which participants have positive posterior canal BPPV.
Primary Purpose:
Diagnostic
Official Title:
Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Patient diagnosed with Posterior canal BPPV

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

Placebo Comparator: Control group

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

Outcome Measures

Primary Outcome Measures

  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 [25min]

    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.

Secondary Outcome Measures

  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. [35min]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Group 1: Experimental group:

Age 18 or older, Patients diagnosed with Posterior canal BPPV, clear nystagmus consistent with the direction of the tested canal and stimulation of the same canal, Patients should have at least mild complaints (no complaints, mild, moderate, severe) Crescendo-decrescendo nystagmus pattern should be observed, with at least a slow-phase eye velocity of 15 deg/sec.

Group 2: Control Group:

Age 18 or older, Patients scheduled for a CT scan for cochlear implantation (CI), no history of vestibular pathology such as DFNA9, meningitis, etc.

Exclusion Criteria:
Experimental group:

Patients with Anterior BPPV or lateral canal BPPV, Patients who are unable to properly undergo the Canalith Repositioning Maneuver (CRM) and Dix Hallpike maneuver, Patients with central vestibular disorders, Patients with Multi-canal BPPV or Subjective BPPV, Pregnant women.

Control group:

Patients with BPPV, central vestibular disorders, or Multi-canal BPPV, Patients with Subjective BPPV or ossifying labyrinthitis, Patients with Deafness, autosomal dominant 9 (DFNA9), Patients with known obstructive vestibular schwannoma on MRI, Patients with normal The video Head Impulse Test (vHIT), Patients with a history of meningitis, Pregnant women. Patients with other vestibular pathologies or past history of BPPV.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Academisch Ziekenhuis Maastricht

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Melliti, Audiologist, PhD Candidate, Academisch Ziekenhuis Maastricht
ClinicalTrials.gov Identifier:
NCT05969340
Other Study ID Numbers:
  • NL 83124.068.22
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali Melliti, Audiologist, PhD Candidate, Academisch Ziekenhuis Maastricht

Study Results

No Results Posted as of Aug 2, 2023