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临床试验/NCT04881435
NCT04881435Unknown不适用

The Effect of Inhaled Hydrogen on the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
hearing recovery

研究概览

简要总结

Idiopathic sudden sensorineural hearing loss (ISSHL) is defined according to American Academy of Otolaryngology as a hearing loss of at least 30 decibel over 3 contiguous test frequencies occurring within a 72h period. It affects 5 to 20 people per 100,000 annually and is characterized by sudden-onset, generally unilateral, sensorineural hearing loss. Its cause is idiopathic in most of the patients; however, vascular disorders have been proposed as the final common pathway. Recent studies have reported that the impaired microvascular perfusion occurring during an ischemic event may be related to oxidative stress which may be synergistically responsible for endothelial damage, especially in terminal microvascular systems.

Hydrogen, which serves as a free radical scavenger and can reduce the strong oxidants, is found as a therapeutic gas in cochlea in recent studies. Both antioxidant and anti-inflammatory effects have been seen with hydrogen administration in animal models. Since cisplatinum toxicity and acoustic trauma both involve oxidative stress to the cochlea, hydrogen may prove useful in these conditions. The efficacy and safety of hydrogen inhalation are also proved in clinical studies.

Given the theories mentioned above, the purpose of our study is to use inhaled hydrogen as an adjuvant therapy for treating idiopathic sudden sensorineural hearing loss. The systemic inflammation status and oxidative stress will be monitored. Both subjective and objective efficacy after treatment will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the criteria of definition of sudden sensorineural hearing loss: hearing loss of 30 dB or more over at least three contiguous frequencies, over a period of 72 hours or less.
  • The event attacked within 14 days. -

排除标准

  • pregnancy or other vulnerable groups
  • specific etiologies of sudden sensorineural hearing loss
  • Diabetes mellitus patients -

结局指标

主要结局

hearing recovery

时间窗: 1.before treatment 2. after treatment immediately 3.one month later after treatment

The level of hearing recovery between the two groups

次要结局

  • the change of systemic inflammatory status and oxidative stress(1.before treatment 2. after treatment immediately 3.one month later after treatment)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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