Evaluating MRI for Hearing Loss and Ménière's Disease
Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménière's Disease
This study is testing if a special type of MRI can help doctors better understand and diagnose hearing loss and Ménière's disease in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06278129 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic and prognostic efficacy of MRI, specifically using 3D-FLAIR sequences, in patients with acute sensorineural hearing loss and Ménière's disease. It aims to identify intralabyrinthine anomalies and characterize vascular and inflammatory patterns through detailed imaging. The study also seeks to correlate MRI findings with clinical and hematological data to better understand the conditions' prognoses. All evaluations are conducted on the same day to enhance the clarity of the results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced sudden hearing loss symptoms within the last 10 days and have no prior episodes of similar conditions.
Not a fit: Patients with known otopathy, labyrinth diseases, or significant systemic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy and treatment outcomes for patients suffering from sudden hearing loss and Ménière's disease.
How similar studies have performed: While the use of MRI in similar contexts has been explored, this specific approach with 3D-FLAIR sequences for these conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- Audiology and Neuroradiology - Milan (Italy) — Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.