Auditory Functions in Patients With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-40
SponsorUniversity of Catania
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age >18 and <50,
no history of hearing loss,
no psychiatric condition
no familial history of otosclerosis/deafness/genetic hearing loss
Disqualifiers
Conductive hearing loss
stroke < 2 years
cardiovascular disease non under control
diabetes
Trial population
Healthy patients and patients with RRMS
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Auditory test
Diagnostic 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
CSF sampling
Other interventionCerebrospinal Fluid will be collected by lumbar puncture and analyzed
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Control2 interventions
Group B: MS group2 interventions
Trial outcomes
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
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Catania
Lead sponsor
Hannover Medical School
Collaborator
Source ClinicalTrials.gov