Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05969340

Detecting Otoconia With CT-Scan

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Academisch Ziekenhuis Maastricht · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTultra-high-resolution CT-scanUse of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV

Timeline

Start date
2023-11-01
Primary completion
2025-03-01
Completion
2025-03-01
First posted
2023-08-01
Last updated
2024-05-01

Source: ClinicalTrials.gov record NCT05969340. Inclusion in this directory is not an endorsement.