Multiple SclerosisNCT06164483
Auditory Functions in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Hearing Disorders, run by University of Catania at 1 site in Italy.
Trial summary
The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Hearing Disorders
- What is being tested?
- Auditory test and CSF sampling
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2026to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy patients and patients with RRMS
Who may be able to join
- age >18 and <50,
- no history of hearing loss,
- no psychiatric condition
- no familial history of otosclerosis/deafness/genetic hearing loss
- patients with PD and/or MS.
Who cannot join
- Conductive hearing loss
- stroke < 2 years
- cardiovascular disease non under control
- diabetes
- hypotensive disorders
- alcohol abuse
- recreational drug consumption
- epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Arianna Di Stadio
Catania, Sicily, 95121
Arianna Di Stadio, MD, PhD, 095/123546, ariannadistadio@hotmail.com
Athanasia Warnecke, MD, PhD
About this study
Official title: Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis
The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.
The results of DPOAE and CSF will be correlated to identify statistically significant correlation.
Read the detailed description
Case-Control study
Tools for patients' selection and inclusion in the study
STEP one
- Full medical records detailed for neurological diseases
- Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)
- Lumbar puncture
- Blood test
- Questionnaire for screening hearing disorders
- App for screening hearing loss
STEP two
- Pure Tone Auditory test + Tympanometry and Stapedial Reflex
- Speech Perception test
- In case of tinnitus: tinnitus questionnaire and acuphenometry
- DPOAEs
- ABR
STEP three in case of Hearing impairment
- MRI Tractography
- Conditions
- Multiple Sclerosis, Hearing Disorders
- Being tested
- Auditory test, CSF sampling
- Medical subject headings
- Multiple Sclerosis, Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory testDiagnostic test
The patients will perform:
Pure Tone Auditory test + Tympanometry and Stapedial Reflex
- Speech Perception test
- In case of tinnitus: tinnitus questionnaire and acuphenometry
- DPOAEs
- ABR
CSF samplingOther
Cerebrospinal Fluid will be collected by lumbar puncture and analyzed
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy patients between 20 and 40 years Receives: Diagnostic Test: Auditory test; Other: CSF sampling | |
| MS group | Patient with Relapsing Remitting MS age between 20 and 40 years Receives: Diagnostic Test: Auditory test; Other: CSF sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory functions and correlation with CSF findings
The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start11 May 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Principal investigator, Arianna Di Stadio, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164483
- Sponsor's protocol ID
- MSSNHL2023
- Status last verified
- May 2026
- First submitted
- 1 Dec 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06164483
- Acronym / sponsor ID
- MSSNHL2023
- Conditions
- Multiple Sclerosis, Hearing Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Dec 2023 (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.
The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.
The results of DPOAE and CSF will be correlated to identify statistically significant correlation.
Detailed description
Case-Control study
Tools for patients' selection and inclusion in the study
STEP one
- Full medical records detailed for neurological diseases
- Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)
- Lumbar puncture
- Blood test
- Questionnaire for screening hearing disorders
- App for screening hearing loss
STEP two
- Pure Tone Auditory test + Tympanometry and Stapedial Reflex
- Speech Perception test
- In case of tinnitus: tinnitus questionnaire and acuphenometry
- DPOAEs
- ABR
STEP three in case of Hearing impairment
- MRI Tractography
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Auditory test, Other: CSF samplingHealthy patients between 20 and 40 years |
| MS group | – | Diagnostic Test: Auditory test, Other: CSF samplingPatient with Relapsing Remitting MS age between 20 and 40 years |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy patients and patients with RRMS
Key inclusion criteria (5 listed)
- age >18 and <50,
- no history of hearing loss,
- no psychiatric condition
- no familial history of otosclerosis/deafness/genetic hearing loss
- patients with PD and/or MS.
Key exclusion criteria (8 listed)
- Conductive hearing loss
- stroke < 2 years
- cardiovascular disease non under control
- diabetes
- hypotensive disorders
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 |
|---|---|---|
| Auditory testThe patients will perform: Pure Tone Auditory test + Tympanometry and Stapedial Reflex * Speech Perception test * In case of tinnitus: tinnitus questionnaire and acuphenometry * DPOAEs * ABR | Diagnostic test | Control, MS group |
| CSF samplingCerebrospinal Fluid will be collected by lumbar puncture and analyzed | Other | Control, MS group |
Primary outcome
Auditory functions and correlation with CSF findings
Time frame: 12 months
The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Multiple Sclerosis and Hearing Disorders, run by University of Catania 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Auditory functions and correlation with CSF findings (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.