Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-19

Study Completion Date

2025-12-31

Brief Summary

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Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.

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Detailed Description

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Aims of the study:

1. Evaluate the diagnostic accuracy of MRI with the collection of more specific sequences for the inner ear (3D-FLAIR) in identifying intralabyrinthine anomalies in patients with Ménière's disease or acute/subacute sudden hearing loss and not only the retrochlear pathology/neurological causes .
2. Characterize the vascular and inflammatory MRI patterns
3. Define the prognostic role of MRI with pre- and post-contrast 3D-FLAIR sequence, eliminating confounding factors such as MRI execution time, the methodology used, the effect of previous therapy and the criteria for defining improvement.
4. Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data

Conditions

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Sudden Sensorineural Hearing Loss Meniere Disease Ménière's Vertigo Meniere's Disease Aggravated Inner Ear Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Vestibular myogenic potentials

observational study

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Magnetic resonance imaging

Eligibility Criteria

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Inclusion Criteria

age \> 18 years

* onset of symptoms less than 10 days
* no previous episodes of sudden ipsilateral hearing loss
* no systemic or oral corticosteroid intake in the previous month
* Informed consent

Exclusion Criteria

* Current or previous otopathy and/or labyrinth diseases of known cause
* Known nervous system disorders
* Patients with renal insufficiency (creatinine level \> 1.5 mg/dL)
* Patients with pacemakers, other metal implants, claustrophobics and known psychiatric disorders
* Pregnant patients Materials and methods Diagnostic evaluation at enrollment (T0)
* Audiological or ENT examination
* Liminal tonal audiometric exam, vocal, impedance measurement, otoacoustic emissions, video-impulse test, oVEMPS, cVEMPS, stabilometry
* Hematological tests: complete blood count, ESR, PCR, creatininemia, CMV IgM, EBV IgM, ANA, glycemia, study of predisposing genetic factors

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No