Screening and Characterization of Hearing Disorders in Diabetic Persons

NCT03437135 | Completed

• 1 other identifier: CHU-371
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes; Hearing Problems

Keywords

diabetes; hearing problems; otoscopy

Outcome Measures

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.

  At day 1 (during the inclusion and screening consultation)

Secondary Outcomes (7)

• mobility of the eardrum-ossicular

  At day 1 (during the inclusion and screening consultation)

• Study of Stapedius reflex

  At day 1 (during the inclusion and screening consultation)

• Study of acoustic ear emissions

  At day 1 (during the inclusion and screening consultation)

• the auditory threshold

  At day 1 (during the inclusion and screening consultation)

• the functionality of external ciliated cells (ECC)

  At day 2 (during the exploration consultation)

Study Arms (3)

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

Glasgow Hearing Status Inventory questionnaire DIAGNOSTIC_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".

Type 1 diabetic patients; Type 2 diabetic patients; Witness patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diabetic persons

You may qualify if:

• type 1 or type 2 diabetic patients

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hearing Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor TAUVERON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 19, 2018
• Study Start: December 1, 2015
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 17, 2020

Record last verified: 2018-02

Locations

FR (1)