Triamcinolone acetonide for Sudden sensorineural hearing loss

Inclusion criteria

• {"criterion_text":"-Patients between 18 and 80 years within 21 days beginning from the onset of SSHL\n-Failed recovery after conservative treatment (systemic and intratympanic steroids) due to persisting SSHL\n-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).\n-Patients with an absolute mean hearing threshold of ≥70dB in the frequencies 0.5, 1, 2 and 4 kHz.\n-Patients who signed the informed consent"}

Exclusion criteria

• {"criterion_text":"-Missing informed consent\n-Patients under permanent corticosteroid therapy\n-Patients with hearing loss due to a (suspected) rupture of the round window membrane according to their history\n-Patients with an intraoperatively detected leak of the round window membrane\n-Repetitive SSHL within the last 12 months on the same side\n-Other ear diseases systemic or otologic (e.g. middle ear diseases, vestibular schwannoma, fluctuating hearing loss, Menière ́s Disease)\n-Central nervous disorders\n-Certain systemic diseases\n-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\n-Preexisting conductive hearing loss on the affected side (mean air- bone gap >10dB in the frequencies 0.5, 1, 2 and 4 kHz)\n-Pregnancy or nursing"}

Primary endpoints

• {"endpoint_text":"-Mean hearing threshold shift on day 30 postoperatively in three sequential frequencies most affected by SSHL.","definition_or_measurement_approach":"Measured by pure tone audiometry; mean hearing threshold shift assessed on day 30 postoperatively in the three sequential frequencies most affected by SSHL."}

Secondary endpoints

• {"endpoint_text":"-Freiburger monosyllable speech intelligibility test and the oldenburg sentence test on day 30 postoperatively\n-Intensity of tinnitus, quality of speech intelligibility and the perception of the own health condition on day 30 postoperatively\n-Proteomics of the perilymph\n-Concentration of triamcinolone acetonide (if applicable) and proteins depending on the results of the perilymph proteomics","definition_or_measurement_approach":"Freiburger monosyllable and Oldenburg sentence tests performed on day 30 postoperatively for speech intelligibility; patient-reported measures for tinnitus intensity, speech intelligibility quality and perceived health on day 30; proteomic analysis of perilymph samples; measurement of triamcinolone acetonide concentration in perilymph if applicable."}

Austria

Earliest CTIS Part Ii Submission Date

03-11-2024

Latest Decision Or Authorization Date

11-12-2024

Processing Time Days

38

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria