Sudden Sensorineural Hearing LossMRI_SSHL/MDNCT06278129
Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease
An observational study of Sudden Sensorineural Hearing Loss and Meniere Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Sensorineural Hearing Loss, Meniere Disease, Ménière's Vertigo
- What is being tested?
- Vestibular myogenic potentials
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients suffering from acute sudden hearing loss and Meniere's disease according to the criteria of the American Academy of Otolaryngology.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Audiology and Neuroradiology - Milan (Italy)
Milan, 20133
Diego Zanetti, MD Prof, 00390255033936, audiologia@policlinico.mi.it
Federica Di Berardino, MD Prof
About this study
Official title: Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménière's Disease
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:
- 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 .
- Characterize the vascular and inflammatory MRI patterns
- 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.
- Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data
- Conditions
- Sudden Sensorineural Hearing Loss, Meniere Disease, Ménière's Vertigo, Meniere's Disease Aggravated, Inner Ear Disease
- Being tested
- Vestibular myogenic potentials
- Medical subject headings
- Hearing Loss, Sudden, Meniere Disease, Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular myogenic potentialsDiagnostic test
Also called Magnetic resonance imaging
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of inner ear structures in MRI images
MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start19 Jun 2018
- Primary completion23 Apr 2021
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278129
- Sponsor's protocol ID
- 4146
- Acronym
- MRI_SSHL/MD
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 28546251Conte 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 30337432Conte 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 29046124Berardino 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 32027195Conte 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 31390618Conte 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 31498290Conte 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménière's Disease
- ClinicalTrials.gov ID
- NCT06278129
- Acronym / sponsor ID
- MRI_SSHL/MD / 4146
- Conditions
- Sudden Sensorineural Hearing Loss, Meniere Disease, Ménière's Vertigo, Meniere's Disease Aggravated, Inner Ear Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aims of the study:
- 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 .
- Characterize the vascular and inflammatory MRI patterns
- 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.
- Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from acute sudden hearing loss and Meniere's disease according to the criteria of the American Academy of Otolaryngology.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular myogenic potentialsAlso: Magnetic resonance imagingobservational study | Diagnostic test | – |
Primary outcome
Evaluation of inner ear structures in MRI images
Time frame: 1 day
MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 28546251Conte 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.
- Background: PubMed 30337432Conte 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.
- Background: PubMed 29046124Conte 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.
- Background: PubMed 32027195Berardino 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.
- Background: PubMed 31390618Conte 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.
- Results publication: PubMed 31498290Conte 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.
- Results publication: PubMed 33895732Conte 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Sensorineural Hearing Loss and Meniere Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of inner ear structures in MRI images (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278129, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.