NCT05661487

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

December 14, 2022

Last Update Submit

December 11, 2023

Conditions

Keywords

Vertigo LabyrinthineLabyrinthitisSudden DeafnessCochlear Diseases

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Location

MeSH Terms

Conditions

LabyrinthitisHearing Loss, SuddenCochlear Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtitisHearing LossHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations