Auditory Functions in Patients With Multiple Sclerosis

NCT06164483 | Recruiting DMC

• 1 other identifier: MSSNHL2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Multiple Sclerosis; Hearing Disorders

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

Control

Healthy patients between 20 and 40 years

Diagnostic Test: Auditory test; Other: CSF sampling

MS group

Patient with Relapsing Remitting MS age between 20 and 40 years

Diagnostic Test: Auditory test; Other: CSF sampling

Interventions

Auditory test DIAGNOSTIC_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

Control; MS group

CSF sampling OTHER

Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

Control; MS group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy patients and patients with RRMS

You may qualify if:

• 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.

You may not qualify if:

• Conductive hearing loss
• stroke \< 2 years
• cardiovascular disease non under control
• diabetes
• hypotensive disorders
• alcohol abuse
• recreational drug consumption
• epilepsy

Sponsors & Collaborators

• University of Catania: lead
• Hannover Medical School: collaborator

Study Sites (1)

Arianna Di Stadio

Catania, Sicily, 95121, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebro-spinal-fluid

MeSH Terms

Conditions

Multiple Sclerosis; Hearing Disorders

Interventions

Audiometry

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor fixed time

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: October 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 24 months for 12 months

Locations

IT (1)