Appilcation of a glucocorticoid into the inner ear of patients with sudden hearing loss
- Conditions
- Sudden sensorineural hearing loss (SSHL)Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2020-005300-19-AT
- Lead Sponsor
- Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>Evaluation of the protein content of the perilymph.;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 Outcome Measures
Name Time Method Secondary end point(s): Freiburger monosyllable speech intelligibility test.<br>Intensity of tinnitus (Mini Tinnitus Questionnaire)<br>Quality of speech intelligibility (Speech, Spatial and Qualities of Hearing scale Questionnaire)<br>Perception of the own health condition (AQOL and HUI-3-questionnaire)<br>Proteomics of the perilymph<br>;Timepoint(s) of evaluation of this end point: On day 30 after the treatment