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临床试验/NCT05474963
NCT05474963招募中不适用

Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年7月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Hearing outcome 1 week - PTA

研究概览

简要总结

This study is to build a cohort of sudden sensorineural hearing loss (SSNHL) patients. When the patient visited the Department of otolaryngology clinic for hearing loss, we can diagnose the SSNHL following the result of pure tone audiometry and the history of the patient. The cohort is a system that tracks the hearing recovery status, timing, and degree of recovery of patients who received cocktail therapy with or without high-dose steroids, vasodilators, antiviral agents, and intratympanic steroid injections, satellite ganglion block, and hyperbaric oxygen therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients over 20 years of age
  • A patient who visited Wonju Severance Christian Hospital, Department of Otolaryngology and was diagnosed with sudden hearing loss as it was confirmed that hearing loss of 30dBHL or more occurred within 3 days at three consecutive frequencies in a pure tone audiometry test.
  • Those who have fully explained the purpose and content of the study and voluntarily agreed to the written consent

排除标准

  • If the patients do not want to or do not fill out the consent form
  • If treatment is started for sudden hearing loss, but the possibility of other inner ear diseases including Meniere's disease is suspected due to repeated hearing loss, repeated recovery, dizziness, tinnitus, etc.
  • Other cases where it is judged difficult to carry out the clinical trial due to the judgment of the person in charge of the above clinical trial

结局指标

主要结局

Hearing outcome 1 week - PTA

时间窗: 1 week PTA

Hearing change status near 1 weak after treatment start measured by pure tone audiometry1

Hearing outcome 3 weeks - PTA

时间窗: 3 weeks PTA

Hearing change status near 3 weaks after treatment start measured by pure tone audiometry

Hearing outcome 3 months - PTA

时间窗: 3 month PTA

Hearing change status near 3 months after treatment start measured by pure tone audiometry

Hearing outcome 6 months - PTA

时间窗: 6 months PTA

Hearing change status near 6 months after treatment start measured by pure tone audiometry, which is final.

Hearing outcome 2 months - PTA

时间窗: 2 month PTA

Hearing change status near 3 weaks after treatment start measured by pure tone audiometry

次要结局

  • Electrolytes and chemistries after high dose steroid therapy(5 days electrolytes and chemistries)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae Hoon Kong, MD, PhD

Assistant Professor

Wonju Severance Christian Hospital

研究点 (1)

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