Sudden sensorineural hearing loss (SSHL)
Conditions
Interventions
Trade Name: Volon A 40
Product Name: Volon A 40
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76-25-5
Concentration unit: 1X 100 milligrams/milli
Sponsors
Medical University Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between 18 and 80 years within 21 days beginning from the onset of SSHL Failed recovery after conservative treatment (systemic and intratympanic steroids) due to persisting SSHL Patients with SSHL with a mean hearing threshold shift of =30dB in three adjacent frequencies (0.125, 0.25, 0.5, 1, 2, 4, 8 kHz). Patients with an absolute mean hearing threshold of =70dB in the frequencies 0.5, 1, 2 and 4 kHz. Patients who signed the informed consent 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Missing informed consent Patients under permanent corticosteroid therapy Patients with hearing loss due to a (suspected) rupture of the round window membrane according to their history Patients with an intraoperatively detected leak of the round window membrane Repetitive SSHL within the last 12 months on the same side Other ear diseases systemic or otologic (e.g. middle ear diseases, vestibular schwannoma, fluctuating hearing loss, Menière´s Disease) Central nervous disorders Systemic diseases (treatment or chronic infections with HIV, hepatitis C or B, tuberculosis, insulin dependent diabetes mellitus, ongoing immune suppressive therapy of rheumatic or chronic-inflammatory illness, instable atherosclerotic diseases, heart diseases > NYHA II, severe psychiatric disorders, severe osteoporosis, ulcus gastric sive duodena, uncontrolled blood pressure (systolic >180 mmHg or diastolic >100 mmHg) Ongoing treatment with aminoglycosides (e.g. gentamicin), erythromycin, tetracycline, chemotherapeutic agents (e.g. cisplatin, 5-fluorouracil, bleomycin), high-dose aspirin (6 to 8 g/day), phosphodiesterase 5 inhibitors (e.g. sildenafil), antimalarial medications (e. g. quinine and chloroquine), loop diuretics (e.g. furosemide, torasemid, acetazolamide), immunosuppressive drugs Preexisting conductive hearing loss on the affected side (mean air-bone gap >10dB in the frequencies 0.5, 1, 2 and 4 kHz) Pregnancy or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Mean hearing threshold shift measured by the pure tone audiometry in three sequential frequencies most affected by SSHL.;Timepoint(s) of evaluation of this end point: On day 30 after the treatment;Main Objective: Evaluation of the effect of intracochlear application of triamcinolone acetonide in the treatment of patients with persistent SSHL undergoing a round membrane sealing after unsuccessful conservative therapy. ;Secondary Objective: Evaluation of the effect of triamcinolone acetonide on the speech intelligibility, intensity of tinnitus, quality of speech intelligibility and perception of the own health condition. Evaluation of the protein content of the perilymph. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Freiburger monosyllable speech intelligibility test. Intensity of tinnitus (Mini Tinnitus Questionnaire) Quality of speech intelligibility (Speech, Spatial and Qualities of Hearing scale Questionnaire) Perception of the own health condition (AQOL and HUI-3-questionnaire) Proteomics of the perilymph ;Timepoint(s) of evaluation of this end point: On day 30 after the treatment | — |
Countries
Austria
Contacts
Public ContactDepartment of Otorhinolaryngology
Medical University Vienne
Outcome results
None listed