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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Hidden Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HHIE-S survey score

Diagnostic Test

First, the patient will fill in the French translation of the HHIE-S questionnaire in the observation book.

Secondly, he will perform the audiometry in silence test: for the tonal test in silence, we will test the frequencies 500, 1000, 2000 and 4000 hertz in each ear with pure tone sound. For the vocal in silence test, we will use the dissyllabic lists of words (Fournier's lists) at the intensities of 20, 30, 40, 50 and 60 decibels. This test will be in free-field conditions testing both ears.
Thirdly, he will perform the speech in noise audiometry test that consists in repeating sentences pronounced at an equal intensity (60 decibels) while the intensity of the noise is increasing. This test will be in free-field conditions testing both ears.

Primary outcomes

Surdity assessed with tonal audiometric examination

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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)

Acronym: VF DEPIST 60

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 12, 2019
Registry last updated: Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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