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临床试验/NCT00222417
NCT00222417Unknown不适用

Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

University Hospital of North Norway1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
44
试验地点
1
主要终点
Post-operative hearing threshold level

研究概览

简要总结

We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

详细描述

Consecutive patients 12 years or older due for myringoplasty or stapes surgery at the ENT-department, University hospital of Tromsø, in an approximate time span of one year, have been studied with the following audiometric investigations at the preoperative admission, 2, 6 and 12 months postoperatively: Transient otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, speech audiometry using spondaic recognition for air and bone-conduction. Results will be statistically analysed using the Statistical Package for the Social Sciences, with the unoperated ear (paired organ) serving as controls. The goal is to look at alternative methods for analysing the patients' preoperative hearing in order to increase the precision of clinical decision-making. The secondary goal is to elucidate the effects of middle ear surgery on the inner ear.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Tympanic membrane perforation without chronic secretion or cholesteatoma
  • Suspected otosclerosis

排除标准

  • Below 12 years of age
  • Patient not consenting to study
  • Perioperative findings suggesting chronic otitis or cholesteatoma
  • Patients not fluent in Norwegian or unable to cooperate in audiometry

结局指标

主要结局

Post-operative hearing threshold level

时间窗: 1 year

Pure tone audiometry, speech audiometry, otoacoustic emissions

次要结局

未报告次要终点

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (1)

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