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
- 是
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
Dan Bing
associate professor
Tongji Hospital
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