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临床试验/NCT03587792
NCT03587792已完成不适用

Study of Binaural Squelch Effect Among Patients Undergoing Unilateral Otosclerosis Surgery: Comparison of Understanding in Noise Before-after Surgery

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Measure of squelch effect 9 months after surgery

研究概览

简要总结

Patients with unilateral transmission hypoacusis due to otosclerosis undergoing stapedectomy surgery will be prospectively included.

They will be undergoing a free field vocal audiometry using the Oldenburg MATRIX software to evaluated the squelch effect gain between audiometry before and after 9months after surgery.

Our hypothesis is to show a squelch effect with the rehabilitation of the binaural audition.

详细描述

Otosclerosis is one of the main causes of transmission hypoacusis. It can be treated with stapedectomy surgery.

But the understanding ability in noise has not been really studied. The Oldenburg MATRIX test is a well know test in audiology and allow to study the understanding in noise.

This study included all the patients coming in our center for stapedectomy for otosclerosis with controlateral audition under 30 decibels (dB) loss.

They will all undergo the MATRIX test in three situations: vocal material and noise from the front of the patient (S0N0 situation); vocal material from the front and noise from the bad-earing side (S0N-90 situation); vocal material from the front and noise from the good-earing side (S0N90 situation).

This might give three informations:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of otosclerosis
  • controlateral audiometry under 30dB loss
  • the ear to be operated with a transmission over 30dB

排除标准

  • otosclerosis which has already operated on the ear studied
  • other cause of transmission hypoacusis
  • transmission after surgery other 30dB

结局指标

主要结局

Measure of squelch effect 9 months after surgery

时间窗: 9 months

Speech reception threshold between S0N90 situation after and before surgery

次要结局

  • Measure of binaural benefit 3 months after surgery(3 months)
  • Measure of binaural benefit 9 months after surgery(9 months)
  • Measure of shadow effect 3 months after surgery(3 months)
  • Improving quality of life : Speech and Spatial Questionnaire(3 months)
  • Measure of squelch effect 3 months after surgery(3 months)
  • Measure of shadow effect 9 months after surgery(9 months)
  • improving quality of life : Abbreviated Profile of Hearing Aid Benefit(3 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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