Detecting Otoconia With CT-Scan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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BPPV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

There are 2 groups involved:

* The experimental group
* The control group

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

The radiologist assessing the CT imaging will be blinded to which participants have positive posterior canal BPPV.

Study Groups

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Experimental group

Patient diagnosed with Posterior canal BPPV

Group Type EXPERIMENTAL

ultra-high-resolution CT-scan

Intervention Type DIAGNOSTIC_TEST

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

Control group

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

Group Type PLACEBO_COMPARATOR

ultra-high-resolution CT-scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ultra-high-resolution CT-scan

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No