Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo

Vertigo Labyrinthine Clinical Trial

— SBAV  

Official title:

Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661487
• Other study ID #: 8265
• Status: Completed
• Start date: May 19, 2021
• Est. completion date: September 19, 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute cochleo-vestibular syndrome or labyrinthitis is characterized clinically by the sudden appearance of a great rotatory vertigo and a unilateral sensorineural hearing loss. In this clinical context, MRI is the examination to eliminate differential diagnoses and to make a positive diagnosis of labyrinthitis (supposedly infectious, immunologic or ischemic). The etiologies described are ischemic, infectious or autoimmune, so the risk factors are very variable (cardiovascular, autoimmune or infectious). Labyrinthitis has been little studied as a clinical entity in its own right. Indeed, studies mainly focus on sudden deafness with subgroups of patients with vertigo. The incidence of sudden deafness is of the order of 5 to 20 per 100,000 people per year but is probably under-diagnosed. The individual and medico-economic consequences are similar to those of hearing loss, with an increased risk of dementia, depression, premature death and an increase in health care consumption.

Description:

The objective of the study is to evaluate the performance of MRI (sensitivity and specificity) to localize labyrinthine damage in the presence of an acute cochleovestibular syndrome (presumed to be infectious, ischemic or immunologic) compared to the reference paraclinical examinations for each of the structures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 19, 2021
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patient of legal age (=18 years)
• MRI diagnosis of labyrinthitis (presumed to be viral, immunologic, or ischemic in origin) at the University Hospitals (HUS) of Strasbourg between 01/01/2014 and 04/30/2021
• Patient with abrupt deafness (a 30 dB drop in hearing thresholds on at least 3 contiguous frequencies for at least 72 hours) associated with unilateral grand rotatory vertigo of abrupt onset
• Patient with severe unilateral acute onset rotary vertigo with acute unilateral hypoacusis.
• Subject who did not express his opposition, after information, to the reuse of his data for the purpose of this research.

Exclusion criteria:

• Subject who expressed opposition to participating in the study.
• History of chronic vertigo,
• Chronic dizziness,
• Presence of a differential diagnosis on MRI (intra-labyrinthine shwannoma, intra-labyrinthine hemorrhage or complicated cholestatoma)
• History of surgery on the inner or middle ear.

Related Conditions & MeSH terms

• Deafness
• Dizziness
• Hearing Loss
• Hearing Loss, Sudden
• Vertigo
• Vertigo Labyrinthine

Locations

Country	Name	City	State
France	Service d'ORL et de Chirurgie Cervico-Faciale - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the performance of MRI (sensitivity and specificity) to localize labyrinthine damage in the presence of an acute cochleovestibular syndrome	The evaluation criterion is the diagnostic performance (sensitivity/specificity) of MRI for each of the structures (basal turn of the cochlea/ 2nd turn of the spire/ 3 semicircular canals, utricle and saccule) in acute labyrinthitis compared to the complementary examinations (Audiogram, VNG, VHIT, cvEMP and VVS)	Files analysed retrospectively from from January 01, 2014 to May 30, 2021 will be examined