Clinical trial NCT05969340: Detecting Otoconia With CT-Scan
Official title: Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: BPPV
Keywords: BPPV
Otoconia
ultra-high resolution CT-imaging
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 groups involved:

* The experimental group
* The control group
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: up to 1 hour
Secondary outcomes:
measure: Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.
timeFrame: up to 1 hour
Other outcomes:
Locations:
Study officials:
References:
citation: von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
citation: von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553.
citation: Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol. 2009 Jul-Aug;75(4):565-72. doi: 10.1016/s1808-8694(15)30497-3.
citation: Yamane H, Konishi K, Anniko M. Visualization of horizontal canal benign paroxysmal positional vertigo using 3DCT imaging and its assessment. Acta Otolaryngol. 2021 May;141(5):482-489. doi: 10.1080/00016489.2021.1892822. Epub 2021 Mar 29.
citation: Rajendran K, Voss BA, Zhou W, Tao S, DeLone DR, Lane JI, Weaver JM, Carlson ML, Fletcher JG, McCollough CH, Leng S. Dose Reduction for Sinus and Temporal Bone Imaging Using Photon-Counting Detector CT With an Additional Tin Filter. Invest Radiol. 2020 Feb;55(2):91-100. doi: 10.1097/RLI.0000000000000614.
citation: Benson JC, Rajendran K, Lane JI, Diehn FE, Weber NM, Thorne JE, Larson NB, Fletcher JG, McCollough CH, Leng S. A New Frontier in Temporal Bone Imaging: Photon-Counting Detector CT Demonstrates Superior Visualization of Critical Anatomic Structures at Reduced Radiation Dose. AJNR Am J Neuroradiol. 2022 Apr;43(4):579-584. doi: 10.3174/ajnr.A7452. Epub 2022 Mar 24.