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临床试验/NCT04159428
NCT04159428已完成不适用

Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More (Hearing Handicap Inventory for the Elderly Screening Version)

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2019年11月7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
294
试验地点
1
主要终点
Surdity assessed with tonal audiometric examination

研究概览

简要总结

Nowadays in France, there is no organized screening of the hearing loss in the elderly; however, it is a very common disease and simples tests to perform to detect it exist. Lots of studies use surveys to identify deaf people; but physicians often consider them too sensitive and less specific because lots of people were classified into " deaf " people meanwhile they have a subnormal tonal audiogram.

Now, it's known that it corresponds to the "Hidden Hearing Loss" concept: it's defined as an auditive disturbance in a noisy ambiance in people with a normal tonal audiometry; corresponding to infraclinical cochlear lesions. These lesions, if detected early, can be prevented to avoid an audition degradation in time.

The aim of the study is to determinate the values of sensitivity and specificity of the HHIE-S survey translated into French, so it could be used as a screening method of hearing loss in the elderly and as a prevention of cochlear damages.

详细描述

The HHIE-S survey is one of the more used in studies to screen hearing loss in elderly. It has never been validated in French: that's why investigatosr want to test it on the French population, to determine its performance characteristics (sensitivity and specificity). Secondary, investigators study think that people that have high score on the hear loss screening survey, but a normal tonal audiometry have actually a hidden hearing loss. This corresponds to infraclinical cochlear lesions that we want to reveal thanks to a new audiometric test: an audiometry in a noisy ambiance.

The study will take place in a research audiometric room in the department of ENT in Bordeaux. Patients will fill a medical survey the HHIE-S survey translated into French and perform a tonal audiometry test and after it a " speech in noise " audiometry test (VRB in French).

The duration os study is one unique session of 45 minutes including patient information and consent.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • are 60 years old and more
  • are able to express their consent
  • are affiliated to the French social security

排除标准

  • have known hearing problem of any kind
  • have performed an audiogram within the past 6 months
  • have required medical examination for any hearing problem
  • have had ear surgery of any kind (except form myringotomy tube during the childhood)
  • have mental or physical serious injury(ies), which results an impossibility to fill a survey and perform an audiogram
  • are under protection schemes

结局指标

主要结局

Surdity assessed with tonal audiometric examination

时间窗: Inclusion (t0)

Primary outcome measure is the presence of surdity on one or two ears of the patient. This Primary outcome will be evaluated with tonal audiometric examination

次要结局

未报告次要终点

研究者

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

研究点 (1)

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