An observational study in Hearing Loss, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by University Hospital, Bordeaux · Observational
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.
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 294 is above the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
French elderly population without hearing problem
Exclusion Criteria:
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.
Surdity assessed with tonal audiometric examination
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
Time frame: Inclusion (t0)
Plan to share: No
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux