JPRN-jRCT1031210700招募中4 期
A randomized controlled trial comparing low or high doses of systemic steroids for idiopathetic sudden sensorineuronal hearing loss and acute low-tone sensorineural hearing loss
Hyakusoku Hiroshi0 个研究点目标入组 160 人开始时间: 2022年3月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Within 2 weeks of the first onset of idiopathic sudden sensorineural hearing loss and acute low-tone sensorineural hearing loss
- •2. Not treated with steroids
- •3. Obtained written informed consent
排除标准
- •1. Patients who are contraindications or relative contraindications to administration of test drug, prednisolone and dexamethasone.
- •2. A case of ipsilateral sensorineural hearing loss in the past. (presbycusis is not included.)
- •3. If there is a disease in the middle ear or outer ear at the time of contract the disease, and pure tone audiometry shows that the average (250, 500, 1000, 2000 and 4000 Hz) of air-bone gap differences is 10 dB or more.
- •4. Among cases in which the contralateral ear has suffered from ear disease in the past and presents with hearing loss, there is no pure tone audiometry (within the past 5 years) before the contract the disease.
- •5. A case that develops with sudden hearing loss and is found to be another disease by subsequent scrutiny and progress.
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