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DiabetesDeCaTAuDiabNCT03437135

Screening and Characterization of Hearing Disorders in Diabetic Persons

An observational study of Diabetes and Hearing Problems, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Diabetes is now the most common chronic disease, affecting nearly 6% of the population in Western populations. Diabetic neuropathy is a priori the most common and the most common specific complications of diabetes. It can of course touch the lower limbs, the vegetative nervous system as well as the cranial nerves. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Hearing Problems
What is being tested?
Glasgow Hearing Status Inventory questionnaire
How many people
172 participants
Where
1 siteFrance
Study dates
1 Dec 2015to 14 Dec 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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: diabetic persons

Who may be able to join

  • type 1 or type 2 diabetic patients

Who cannot join

  • history of otological surgical act
  • presence of neurological or psychiatric disorders that may impair the quality of explorations
  • presence of a obstructive wax stopper or au foreign body found in the simple otoscopy (or impossibility of this extraction).

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: Screening and Characterization of Hearing Disorders in Diabetic Persons.

Diabetes is now the most common chronic disease, affecting nearly 6% of the population in Western populations. Diabetic neuropathy is a priori the most common and the most common specific complications of diabetes. It can of course touch the lower limbs, the vegetative nervous system as well as the cranial nerves. However, the association between hearing impairment and diabetes has always been controversial on the basis of conflicting literature data. Are auditory disorders an underestimated complication of diabetes? A meta-analysis made in 2013, examined the scientific literature between 1950 and 2011 and of the 3158 citations, only 13 articles were selected. This study found that hearing impairment in diabetic patients was 2.1 times more prevalent than in non-diabetic matched subjects. In addition, the age / aging factor is associated with the prevalence of hearing loss and diabetes. However, it also appears that the link between diabetes and hearing impairment is more pronounced among young people than older people. In order to document the influence of diabetic pathology on hearing, Investigator have set up a search audiological exploration platform within the department of Endocrinology-Diabetology of Clermont-Ferrand University Hospital. It will be proposed a hearing screening (duration 30 minutes) and a questionnaire to diabetic patients of the service. In the context of a positive screening, that is to say that one of the tests carried out reveals the presence of a hearing disorder, an in-depth assessment of the hearing will be carried out to better characterize the origin of the auditory disturbance (duration 60-90 minutes). These different tests are based on the listening of sounds requiring or not the participation of patient. Thus, the results of the various tests will make it possible to classify the impairment of hearing in (1) peripheral impairment (dysfunction of certain cells of your ear involved in the amplification of sounds), and / or (2) in neural damage (dysfunction of your auditory nerve).

Read the detailed description

Diabetes is now the most common chronic disease since it affects western populations such as France almost 6% of the population. This disease is particularly costly for social protection systems, not only for the cost of daily care but also by the occurrence of Chronic complications that are leading to major co-morbidities. Thus, diabetes is a major cardiovascular risk factor. Diabetes also leads to micro-angiopathic complications: Diabetic retinopathy eventually ends up in evolved forms to the first cause of young subject blindness in developed countries. Nephropathy is one of the first causes of terminal renal failure leading to extra renal treatment.

Diabetic neuropathy seems to be the most common and the most common of the specific complications of diabetes. It can of course touch the lower limbs, most often training a symmetrical and distal motor polyneuritis, responsible for the term of Neuro arthropathy of Charcot. The vegetative nervous system can also be achieved with cardiovascular, gastrointestinal, genitourinary, neuro-vascular, metabolic and pupil consequences. The injuries of the cranial nerves are also possible and are most frequently characterized by facial paralysis or motor eye nerves.

The association between hearing disorders and diabetes has always aroused controversy on the part of contradictory literature data. Are hearing disorders an underestimated complication of diabetes? A recent meta-analysis of 2013, examined the scientific literature between 1950 and 2011 and of the 3158 citations, only 13 articles were selected (with more than 20 000 participants). This study found that hearing disorders in diabetic patients were 2.1 times more prevalent than in non-diabetic paired subjects. In addition, the age/aging factor is associated with the prevalence of hearing impairment and diabetes. However, it also appears that the link between diabetes and hearing disorder is more pronounced among young people than the elderly.

Nevertheless, it is regrettable that in the majority of the "diabetes-hearing disorders" studies were not exhaustive from the point of view of the documentation of the alteration of the hearing function. Indeed, the indices of impairment of the hearing are essentially based on a review of the audiograms. No more relevant objective test, allowing to evaluate more precisely the different functional compartments of the inner ear, has been achieved. Indeed, it would be wise to elucidate which (s) are the targets (s) of the diabetes. Classical hearing impairment mainly affects cochlear sensory cells and more specifically external hair cells. However, it is possible to envisage that the alteration of the micro-vascularization of the vascular Streak (ischemic disorders), a selective expectation of the nerve fibers (hearing neuropathy), the metabolic disturbances at the mitochondrial level, Oxidative stress with free radical production, advanced glycation products (AGE, advanced glycation end-products).

Objectives:

  • The primary objective is the assessment of the prevalence of hearing impairment (with or without clinical manifestation) in a population of type 1 and type 2 diabetic persons treated and followed during a hospitalization or consultation in the Department of Endocrinology-Diabetology of the CHU de Clermont-Ferrand.
  • The second objectives are:

Identify the proportion of patients with a peripheral explanation for their hearing impairment (involvement of the outer ciliated cells, 'classic deafness) Identify the proportion of patients who have a neural explanation for their hearing impairment (hearing-type neuropathy) And categorize types of hearing impairment by types of diabetes, its balance, age, absence or absence of complication, age of patient, sex of patient, noise exposure in a professional manner or as a part of recreation, taking ototoxic drugs, smoking.

Being tested
Glasgow Hearing Status Inventory questionnaire
Keywords
diabetes, hearing problems, otoscopy
Medical subject headings
Diabetes Mellitus, Hearing Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glasgow Hearing Status Inventory questionnaireDiagnostic test

    This is a questionnaire of the hearing quality presenting eleven questions. This is allows to determine the quality of the hearing status of the patients. It is enough to answer the various questions "yes" or "no".

Study groups in NCT03437135
Study groupRoleWhat they receive
Witness patientsHealthy Volunteers
Receives: Diagnostic Test: Glasgow Hearing Status Inventory questionnaire
Type 1 diabetic patientspatients with type 1 diabetes
Receives: Diagnostic Test: Glasgow Hearing Status Inventory questionnaire
Type 2 diabetic patientspatients with type 2 diabetes
Receives: Diagnostic Test: Glasgow Hearing Status Inventory questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. presence or not of an ear wax cap

    A single ostoscopie is performed using a portable otoscope and single-use Speculum to verify the absence of any wax cap.

    Measured: At day 1 (during the inclusion and screening consultation)

Secondary outcomes (7)
  1. mobility of the eardrum-ossicular

    From a tympanometry probe with a single-use mouthpiece, the mobility of the eardrum is studied and therefore the functional state of the middle ear.

    Measured: At day 1 (during the inclusion and screening consultation)

  2. Study of Stapedius reflex

    From a tympanometry probe with a single-use mouthpiece, the study of Stapedius reflex allows to evaluate the functionality of a reflex neurological loop of the brainstem. The stapedium reflex rating is "present " or "absent "

    Measured: At day 1 (during the inclusion and screening consultation)

  3. Study of acoustic ear emissions

    A measuring probe is carefully inserted into the external ear canal and an analysis of the overall responses of the cochlea is carried out following the application of an acoustic stimulation. The ear emission rating is "present " or "absent

    Measured: At day 1 (during the inclusion and screening consultation)

  4. the auditory threshold

    A tonal audiogram for 6 frequencies from 250 to 8000 will be achieved to determine of auditory threshold

    Measured: At day 1 (during the inclusion and screening consultation)

  5. the functionality of external ciliated cells (ECC)

    this is a non-invasive, simple, fast and objective assay for exploring the functionality of external ciliated cells (ECC). This test is similar test in some aspects to the test of acoustic ear emissions, but allows to have an analysis of cochlear answers (and more specifically ECC) not global but between 1000 hertz and 8000 hertz

    Measured: At day 2 (during the exploration consultation)

  6. Early auditory evoked potentials (or eAEP)

    Electrodes are positioned at specific points at the level of the scalp (according to the system 10/20, at the level of the vertex and in frontal-median Fp).

    Measured: At day 2 (during the exploration consultation)

  7. frequency selectivity of the patient

    the objective of this test is to measure the selectivity in frequency for three frequencies (1000, 2000 and 4000hertz).

    Measured: At day 2 (during the exploration consultation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start1 Dec 2015
  3. Primary completion14 Dec 2020
  4. Study completion14 Dec 2020

Resources

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
Cross-sectional
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437135
Sponsor's protocol ID
CHU-371
Acronym
DeCaTAuDiab
Status last verified
Aug 2026
First submitted
12 Jan 2018
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Giraudet F, Mulliez A, de Resende LM, Beaud L, Benichou T, Brusseau V, Tauveron I, Avan P. Impaired auditory neural performance, another dimension of hearing loss in type-2 diabetes mellitus. Diabetes Metab. 2022 Nov;48(6):101360. doi: 10.1016/j.diabet.2022.101360. Epub 2022 Jun 1.

    PubMed 35660525

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Hearing Problems, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 3 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 10 Aug 2026. 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?

presence or not of an ear wax cap (time frame: At day 1 (during the inclusion and screening consultation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437135, which also lists 1 linked publication.

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 10 Aug 2026.

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