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临床试验/NCT03715569
NCT03715569Unknown不适用

CNS Infections Effect on the Inner Ear

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
700
试验地点
1
主要终点
Cochlear damage

研究概览

简要总结

Study on patients with CNS infections.

详细描述

Aims and objectives:

The present proposal aims to improve the outcome from central nervous system infections (CNS) by improving the understanding of when and why patients develop hearing loss and other neurological sequelae. The investigators will elucidate the temporal development and restitution of a sensorineural hearing loss and will clarify if any therapeutic window exists, where sequelae can be limited.

Also the investigators will investigate if communication between cochlea and cerebrospinal fluid is a window to the intracranial pressure.

Background:

CNS infections remain diseases with high mortality and morbidity. Among survivors from bacterial meningitis, 30 % suffer hearing loss or deafness arising from injury to the inner ear - the cochlea. From previous work it is known that brain inflammation, brain edema and subsequent pressure changes can be transduced to the inner ear due to communication between the cochlea and cerebrospinal fluid (CSF).

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a CNS infection admitted to the hospital.

排除标准

  • Patients with known hearing loss

结局指标

主要结局

Cochlear damage

时间窗: Day1-90

Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.

次要结局

  • Vestibular function loss(Day 1-90)
  • Identifying biochemical markers in CSF during a CNS infection(Day 1-90)
  • Cognitive impairment(Day 90)

研究者

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

Elisa Skovgaard Jensen

Principal Investigator

Nordsjaellands Hospital

研究点 (1)

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