Validation & Evaluation of the French Version of a Hearing Loss Screening

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04159428
Study type	Observational
Source	University Hospital, Bordeaux
Contact
Status	Completed
Phase
Start date	November 7, 2019
Completion date	May 27, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More — VF DEPIST 60

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms