Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo
SBAV
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2021
CompletedFirst Submitted
Initial submission to the registry
December 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedDecember 12, 2023
December 1, 2022
3 months
December 14, 2022
December 11, 2023
Conditions
Keywords
Outcome Measures
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)
Files analysed retrospectively from from January 01, 2014 to May 30, 2021 will be examined
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'ORL et de Chirurgie Cervico-Faciale - CHU de Strasbourg - France
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2022
First Posted
December 22, 2022
Study Start
May 19, 2021
Primary Completion
August 19, 2021
Study Completion
September 19, 2021
Last Updated
December 12, 2023
Record last verified: 2022-12