2024-513145-36-00招募中2 期
Intracochlear Triamcinolone acetonide in sudden sensorineural hearing loss patients - a prospective observer blinded randomized study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean hearing threshold shift on day 30 postoperatively in three sequential frequencies most affected by SSHL.
研究概览
简要总结
Evaluation of the effect of intracochlear application of triamcinolone acetonide on hearing function measured by the pure tone audiometry, in the treatment of patients with persistent sudden sensorineural hearing loss (SSHL) after unsuccessful conservative therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Missing informed consent
- •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
- •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
- •Certain systemic diseases
- •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
结局指标
主要结局
Mean hearing threshold shift on day 30 postoperatively in three sequential frequencies most affected by SSHL.
Mean hearing threshold shift on day 30 postoperatively in three sequential frequencies most affected by SSHL.
次要结局
- Freiburger monosyllable speech intelligibility test and the oldenburg sentence test on day 30 postoperatively
- Intensity of tinnitus, quality of speech intelligibility and the perception of the own health condition on day 30 postoperatively
- Proteomics of the perilymph
- Concentration of triamcinolone acetonide (if applicable) and proteins depending on the results of the perilymph proteomics
研究者
Department of Ear, Nose and Throat Disease
Scientific
Medical University Of Vienna
研究点 (1)
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