Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adul… (NCT04159428) | Clinical Trial Compass
CompletedNot Applicable
Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More
France294 participantsStarted 2019-11-07
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surdity assessed with tonal audiometric examination