In our study we try to evaluate the effect of intratympanic Triamcinolon acetonide and Dexamethason 21-dihydrohenphosphat on vertigo control calculation, Hydrops MRI, vHIT (video head impuls test), caloric testing, audiological examination including discrimination of speech test and on the basis of a quality of life questionnaire.
Conditions
Interventions
Trade Name: Volon A 40
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
Other descriptive name: Volon A 40
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
Abteilung für Hals-, Nasen- und 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 with no retrocochlear or intracerebral pathology on cMRI • Patients between 18 and 90 years 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) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: •Patients with severe neurological disorders •Patients with chronic otitis media •Patients who were already treated with Gentamicin •Patients younger than 18 years •Pregnant and breastfeeding women •Patients with Contrast agent allergy •Patients with contraindications against the administration of Triamcinolone acetonide and Dexamethason 21-dihydrogenphosphat •Patients who take corticoteroids on a regular basis •Patients with non MRI-compatible implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the influence of intratympanic corticosteroid treatment (Dexamethasone 21-dihydrogenphosphat or Triamcinolone acetonide) on vertigo control in Menière’s disease patients after 24 months ;Secondary Objective: •To assess the improvement in quality of life in each group and the difference between the Groups on quality of live questionnaires (follow-up 24 months) •To assess the difference in treatment efficacy between Dexamethasone and Triamcinolone in audiometry, Video Head impuls test and caloric test 6 and 24 months after therapy • To assess the improvement in audiometry in both groups 6 and 24 months after therapy • To assess the correlation between the outcomes of Video Head Impuls Test and caloric test in both groups and the difference between the groups • To assess the treatment efficacy of Dexamethasone and Triamcinolone and the difference between the groups as measured by hydrops MRI •To assess the correlation between vertigo control and Hydrops MRI results •To assess the influence on the course of disease by therapy. ;Primary end point(s): Vertigo control rate 24 months after treatment with Triamcinolone acetonide and Dexamethasone 21-dihydrogenphosphat. ;Timepoint(s) of evaluation of this end point: 24 months nach Therapie | — |
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 video Head impuls Test (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 für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
Outcome results
None listed