ClinicalTrials.gg
RecruitingNCT06278129MRI_SSHL/MDUpdated Feb 26, 2024

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

An observational study in Sudden Sensorineural Hearing Loss, Meniere Disease and Ménière's Vertigo, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

From the registry’s dates

  • Started Jun 2018; still recruiting 8 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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
02

Conditions studied

  • Sudden Sensorineural Hearing Loss
  • Meniere Disease
  • Ménière's Vertigo
  • Meniere's Disease Aggravated
  • Inner Ear Disease
03

In context

Hearing Loss, Sudden

66 studies on the registry are indexed under Hearing Loss, Sudden; 25 are open to participants now.

This study's planned enrollment of 64 is below the median of 82 across 14 observational studies indexed under Hearing Loss, Sudden.

Browse Hearing Loss, Sudden studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 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
Sampling method
Probability sample

Study population

Patients suffering from acute sudden hearing loss and Meniere's disease according to the criteria of the American Academy of Otolaryngology.

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

age > 18 years

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

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testVestibular myogenic potentials

    observational study

    Also known as: Magnetic resonance imaging

06

What researchers measure

Primary outcomes

  1. Evaluation of inner ear structures in MRI images

    MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Audiology and Neuroradiology - Milan (Italy)
    Milan, 20133, Italy
    Recruiting
    • Diego Zanetti, MD Prof · Contactaudiologia@policlinico.mi.it · 00390255033936
    • Federica Di Berardino, MD Prof · Principal investigator
    • Giorgio Conte, MD Prof · Principal investigator
08

References and documents

Publications

  • Conte G, Di Berardino F, Sina C, Zanetti D, Scola E, Gavagna C, Gaini L, Palumbo G, Capaccio P, Triulzi F. MR Imaging in Sudden Sensorineural Hearing Loss. Time to Talk. AJNR Am J Neuroradiol. 2017 Aug;38(8):1475-1479. doi: 10.3174/ajnr.A5230. Epub 2017 May 25. PubMed 28546251 ↗
  • Conte G, Caschera L, Calloni S, Barozzi S, Di Berardino F, Zanetti D, Scuffi C, Scola E, Sina C, Triulzi F. MR Imaging in Meniere Disease: Is the Contact between the Vestibular Endolymphatic Space and the Oval Window a Reliable Biomarker? AJNR Am J Neuroradiol. 2018 Nov;39(11):2114-2119. doi: 10.3174/ajnr.A5841. Epub 2018 Oct 18. PubMed 30337432 ↗
  • Conte G, Di Berardino F, Zanetti D, Avignone S, Sina C, Iofrida E, Triulzi F. The 'full-blown' MRI of sudden hearing loss: 3D FLAIR in a patient with bilateral metastases in the internal auditory canals. Neuroradiol J. 2018 Feb;31(1):39-41. doi: 10.1177/1971400917736927. Epub 2017 Oct 19. PubMed 29046124 ↗
  • Berardino FD, Conte G, Turati F, Ferraroni M, Zanetti D. Cochlear implantation in Meniere's disease: a systematic review of literature and pooled analysis. Int J Audiol. 2020 Jun;59(6):406-415. doi: 10.1080/14992027.2020.1720922. Epub 2020 Feb 6. PubMed 32027195 ↗
  • Conte G, Lo Russo F, Caschera L, Zanetti D, Castorina P, Sina C, Triulzi F, Di Berardino F. Audiovestibular Phenotypes and Advanced Magnetic Resonance Imaging Features of Cochlin Gene Mutation Carriers. Audiol Neurootol. 2019;24(4):166-173. doi: 10.1159/000501292. Epub 2019 Aug 7. PubMed 31390618 ↗
  • Conte G, Di Berardino F, Zanetti D, Iofrida EF, Scola E, Sbaraini S, Filipponi E, Cinnante C, Gaini LM, Ambrosetti U, Triulzi F, Pignataro L, Capaccio P. Early Magnetic Resonance Imaging for Patients With Idiopathic Sudden Sensorineural Hearing Loss in an Emergency Setting. Otol Neurotol. 2019 Oct;40(9):1139-1147. doi: 10.1097/MAO.0000000000002389. PubMed 31498290 ↗
  • Conte G, Di Berardino F, Mastrapasqua RF, Casale S, Scola E, Capaccio P, Triulzi F, Pignataro L, Zanetti D. Prognostic Value of Early Magnetic Resonance Imaging Patterns in Sudden Hearing Loss. Audiol Neurootol. 2022;27(1):64-74. doi: 10.1159/000515153. Epub 2021 Apr 23. PubMed 33895732 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06278129
Responsible party
Sponsor
First posted
Feb 26, 2024
Start date
Jun 19, 2018
Primary completion
Apr 23, 2021
Completion
Dec 31, 2025 (estimated)
Last update
Feb 26, 2024

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion