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临床试验/NCT06365775
NCT06365775尚未招募不适用

Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Dan Bing0 个研究点目标入组 400 人开始时间: 2024年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Pure tone audiometry (PTA)

研究概览

简要总结

The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:

  • if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
  • if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
  • to find out which factor from multi-omics data relates to outcomes of SSNHL
  • to develop the best prognostics model based on the multi-omics data.

Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.

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
4 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with SSNHL: unilateral or bilateral sensorineural hearing loss of > 30 dB HL (decibel) involving at least 3 continuous test frequencies developing within 72 hours
  • Healthy controls: people with PTA thresholds of all test frequencies ≤ 20 dB HL and without otologic disease in the last 3 months
  • Completed informed consent and promised to finish follow-ups

排除标准

  • Hearing loss with explicit causes, including noise-induced, Ménière's disease, ototoxicity exposure, mumps infection or history of syphilis infection and so on.
  • A history of head trauma or otologic surgery.
  • Malformation of temporal bone discovered by computed tomography (CT)
  • Retro-cochlear lesion discovered by magnetic resonance imaging (MRI)
  • Pregnant women

结局指标

主要结局

Pure tone audiometry (PTA)

时间窗: Baseline, 14 days, 1, 3 and 6 months follow-ups

Pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz will be measured.

次要结局

  • Speech reception thresholds(Baseline, 14 days, 1, 3 and 6 months follow-ups)
  • Speech discrimination scores(Baseline, 14 days, 1, 3 and 6 months follow-ups)

研究者

发起方
Dan Bing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dan Bing

associate professor

Tongji Hospital

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