Hearing LossVF DEPIST 60NCT04159428
Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More
An observational study of Hearing Loss, run by University Hospital, Bordeaux at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- HHIE-S survey score
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2019to 27 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: French elderly population without hearing problem
Who may be able to join
- are 60 years old and more
- are able to express their consent
- are affiliated to the French social security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the detailed 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.
- Conditions
- Hearing Loss
- Being tested
- HHIE-S survey score
- Keywords
- hearing loss, screening, elderly, hidden hearing loss, speech in noise audiometry, HHIE-S survey
- Medical subject headings
- Hearing Loss, Hearing Loss, Hidden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHIE-S survey scoreDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion (t0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start7 Nov 2019
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159428
- Sponsor's protocol ID
- CHUBX 2019/15
- Acronym
- VF DEPIST 60
- Status last verified
- Jun 2020
- First submitted
- 30 Oct 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04159428
- Acronym / sponsor ID
- VF DEPIST 60 / CHUBX 2019/15
- Conditions
- Hearing Loss
- Keywords
- hearing loss, screening, elderly, hidden hearing loss, speech in noise audiometry, HHIE-S survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- French elderly population without hearing problem
Key inclusion criteria (3 listed)
- are 60 years old and more
- are able to express their consent
- are affiliated to the French social security
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HHIE-S survey scoreFirst, 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. | Diagnostic test | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surdity assessed with tonal audiometric examination (time frame: Inclusion (t0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.