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CompletedNCT05661487SBAVUpdated Dec 12, 2023

Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo

An observational study in Vertigo Labyrinthine, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vertigo Labyrinthine

Keywords

  • Vertigo Labyrinthine
  • Labyrinthitis
  • Sudden Deafness
  • Cochlear Diseases
03

In context

Labyrinthitis

20 studies on the registry are indexed under Labyrinthitis; 5 are open to participants now.

Browse Labyrinthitis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Files analysed retrospectively from from January 01, 2014 to May 30, 2021 will be examined

07

Study locations

1 site
  • Service d'ORL et de Chirurgie Cervico-Faciale - CHU de Strasbourg - France
    Strasbourg, 67091, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05661487
Responsible party
Sponsor
First posted
Dec 22, 2022
Start date
May 19, 2021
Primary completion
Aug 19, 2021
Completion
Sep 19, 2021
Last update
Dec 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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