In our study we try to evaluate the the effect of common therapies in Menière´s disease patients on vertigo control calculation, Hydrops MRI, vHIT (video head impuls test) , caloric testing, audiological examination, and on the basis of quality of life questionnaires.
Conditions
Interventions
Trade Name: Refobacin 80mg intratympanic injection (2ml)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GENTAMICIN SULFATE
CAS Number: 1405-41-0
Other descriptive name: Gentamicin Su
Sponsors
Abteilung für Hals- Nasen- Ohrenkrankheiten MUW, AKH Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients, who suffer from „definite Menière`s Disease“, according to the AAO-HNS guidelines. • Patients between 18 and 90 years will be included. • Patients who underwent intratympanic steroid therapy within the last six months before therapy • Patients who underwent any conservative therapy within the last six months before therapy • Patients who had a ventilation tube until six months ago Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Patients with severe neurological disorders o Severe neurological disorders, which are relevant for our study are tumor diseases, neurodegenerative diseases, more than one epileptic seizure in patient´s history. • Patients younger than 18 years • Pregnant and breastfeeding women • Patients with retrocochlear or intracerebral pathology on cMRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the treatment in Menière’s disease patients after 24 months quantified by the vertigo control rate;Secondary Objective: •To assess the correlation between hydrops MRI outcomes and the vertigo control in all groups 6 and 24 months after treatment •To assess the correlation between hydrops MRI outcomes and vHIT (video head impuls test) outcomes in all groups 6 and 24 months after treatment • To assess the correlation between hydrops MRI outcomes and caloric testing outcomes in all groups 6 and 24 months after treatment (except patients with LE and ventilation tubes ;Primary end point(s): Vertigo control rate 24 months after treatment ;Timepoint(s) of evaluation of this end point: 24 Months after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The hearing outcomes in audiometry (Hz/dB, Air conduction, bone conduction) 6 and 24 months after therapy The vHIT (diminished function in one of the semicircular canals; yes/no) 6 and 24 months after therapy The caloric testing (diminished function of the vestibular organ; yes/no) 6 and 24 months after therapy The quality of life based on the Questionnaires 6 months and 24 months after therapy Hydrops MRI outcomes 6 and 24 months after therapy ;Timepoint(s) of evaluation of this end point: 6 and 24 months after therapy | — |
Countries
Austria
Contacts
Public ContactHNO Ambulanz 8J
Universitätsklinik Hals- Nasen- Ohrenkrankheiten MUW, AKH Wien
Outcome results
None listed