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CompletedNCT03437135DeCaTAuDiabUpdated Aug 10, 2026

Screening and Characterization of Hearing Disorders in Diabetic Persons

An observational study in Diabetes and Hearing Problems, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
172
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetes
  • Hearing Problems

Keywords

  • diabetes
  • hearing problems
  • otoscopy
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 172 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

diabetic persons

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • type 1 or type 2 diabetic patients

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
172 participants (actual)
Patient registry
No

Groups and cohorts

  • Witness patients

    Healthy Volunteers

    Diagnostic Test: Glasgow Hearing Status Inventory questionnaire

  • Type 1 diabetic patients

    patients with type 1 diabetes

    Diagnostic Test: Glasgow Hearing Status Inventory questionnaire

  • Type 2 diabetic patients

    patients with type 2 diabetes

    Diagnostic Test: Glasgow Hearing Status Inventory questionnaire

Interventions

  • Diagnostic testGlasgow Hearing Status Inventory questionnaire

    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".

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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 "

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: At day 2 (during the exploration consultation)

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2015 to primary completion in Dec 2020, 60 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2018
First posted
Feb 19, 2018
StartActual
Dec 1, 2015
Primary completionActual
Dec 14, 2020
CompletionActual
Dec 14, 2020
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437135
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Dec 1, 2015
Primary completion
Dec 14, 2020
Completion
Dec 14, 2020
Last update
Aug 10, 2026

Study contacts

Igor TAUVERON
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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