Screening and Characterization of Hearing Disorders in Diabetic Persons (DeCaTAuDiab)

• ClinicalTrials.gov Identifier: NCT03437135
• Recruitment Status: Completed
• First Posted: February 19, 2018
• Last Update Posted: December 17, 2020
• Sponsor: University Hospital, Clermont-Ferrand
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

Study Description

Brief 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).

Condition or disease	Intervention/treatment
Diabetes; Hearing Problems	Diagnostic Test: Glasgow Hearing Status Inventory questionnaire

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 172 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Screening and Characterization of Hearing Disorders in Diabetic Persons.
• Actual Study Start Date: December 1, 2015
• Actual Primary Completion Date: December 14, 2020
• Actual Study Completion Date: December 14, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Witness patients; Healthy Volunteers	Diagnostic Test: Glasgow 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".
Type 1 diabetic patients; patients with type 1 diabetes	Diagnostic Test: Glasgow 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".
Type 2 diabetic patients; patients with type 2 diabetes	Diagnostic Test: Glasgow 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".

Outcome Measures

Primary Outcome Measures :

1. presence or not of an ear wax cap [ Time Frame: At day 1 (during the inclusion and screening consultation) ]
   A single ostoscopie is performed using a portable otoscope and single-use Speculum to verify the absence of any wax cap.

Secondary Outcome Measures :

1. mobility of the eardrum-ossicular [ Time Frame: At day 1 (during the inclusion and screening consultation) ]
   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.
2. Study of Stapedius reflex [ Time Frame: At day 1 (during the inclusion and screening consultation) ]
   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 "
3. Study of acoustic ear emissions [ Time Frame: At day 1 (during the inclusion and screening consultation) ]
   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
4. the auditory threshold [ Time Frame: At day 1 (during the inclusion and screening consultation) ]
   A tonal audiogram for 6 frequencies from 250 to 8000 will be achieved to determine of auditory threshold
5. the functionality of external ciliated cells (ECC) [ Time Frame: At day 2 (during the exploration consultation) ]
   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
6. Early auditory evoked potentials (or eAEP) [ Time Frame: At day 2 (during the exploration consultation) ]
   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).
7. frequency selectivity of the patient [ Time Frame: At day 2 (during the exploration consultation) ]
   the objective of this test is to measure the selectivity in frequency for three frequencies (1000, 2000 and 4000hertz).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

diabetic persons

Criteria

Inclusion Criteria:

• type 1 or type 2 diabetic patients

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).

Contacts and Locations

Locations

France

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Igor TAUVERON; University Hospital, Clermont-Ferrand

More Information

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT03437135
• Other Study ID Numbers: CHU-371
• First Posted: February 19, 2018
• Last Update Posted: December 17, 2020
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:

diabetes; hearing problems; otoscopy

Additional relevant MeSH terms:

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases