Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo (SBAV)

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.

Study Overview

• Status: Completed
• Conditions: Vertigo Labyrinthine

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Aadult patient with MRI diagnosis of labyrinthitis (presumed to be viral, immunologic, or ischemic in origin) at HUS between 01/01/2014 and 04/30/2021

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): August 19, 2021
• Study Completion (Actual): September 19, 2021

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Labyrinthitis; Vertigo Labyrinthine; Sudden Deafness; Cochlear Diseases
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Hearing Disorders; Vertigo; Dizziness; Hearing Loss; Deafness; Hearing Loss, Sudden
• Other Study ID Numbers: 8265

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No