BPPV Clinical Trial - Detecting Otoconia With CT-Scan

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

BPPV

Clinical Trial Details

NCT number	NCT05969340
Study type	Interventional
Source	Academisch Ziekenhuis Maastricht
Contact
Status	Withdrawn
Phase	N/A
Start date	November 1, 2023
Completion date	March 1, 2025

View Details

See also
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Recruiting	`NCT05634902` - Implementation of Evidence-Based Practice for Dizziness	N/A
Completed	`NCT05853328` - Comparison of EM and SM+ Maneuvers in Patients With BPPV	N/A
Not yet recruiting	`NCT05863949` - Clinical Trial of Vit D and Calcium for Recurrent BPPV	N/A
Recruiting	`NCT06228196` - Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
Completed	`NCT04147156` - Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV	N/A
Completed	`NCT05960786` - Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand	N/A
Completed	`NCT05575362` - Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in BPPV	N/A
Recruiting	`NCT05834452` - Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.	N/A
Completed	`NCT05846711` - The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.	N/A
Completed	`NCT03871413` - TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.