Detecting Otoconia With CT-Scan

April 30, 2024 updated by: Ali Melliti, Academisch Ziekenhuis Maastricht

Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Ziekenhuis Maastricht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL 83124.068.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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