Intracochlear application versus round window instillation of Triamcinolone acetonide in patients with sudden sensorineural hearing loss-a comparative study

Medical University Vienna0 个研究点目标入组 60 人开始时间: 2020年11月23日最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•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

发起方

Medical University Vienna