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The study aims to phenotype hearing in patients with early stage of neurodegenerative disorders to explore the prevalence of various hearing disorders in comparison to a control population. Specific focus is made on patients with speech-in-noise intelligibiltiy deficit despite normal tonal audiograms referred to as hidden hearing loss, with potential identification of associated biomarkers.
A wide battery of subjective and objective hearing tests is performed on the subjects including tonal and vocal audiometry (in silence and in noise), DPOAE, acoustic reflex and electrophysiology recordings (auditory brainstem response, electrocochleography). Hearing tests are correlated to collected disease parameters and blood markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Control population |
|
| Amnestic MCI Group | Experimental | Patients with amnestic mild cognitive impairment |
|
| Parkinson Group | Experimental | Patient with parkinson's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thorough Hearing assessment | Other | Otoscopy Tympanometry Tonal audiometry (air and bone conduction) Vocal audiometry (in silence and in noise) Distorsion Products of OtoAcoustic Emissions (DPOAE) Middle Ear Muscle Reflex (MEMR) Auditory Brainstem Response (ABR) Electrocochleography (EcochG) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hidden hearing loss | Percentage of population in each group that displays normal audiometric thresholds (0.5-4kHz) and impaired speech-in-noise intelligibility | within one month from inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of sensorineural hearing loss | Percentage of patients in each group with elevated hearing thresholds (0.5-4kHz) | within one month from inclusion |
| Grade of sensorineural hearing loss |
| Measure | Description | Time Frame |
|---|---|---|
| Explore auditory signatures in neurodegenerative disease patients | Determine combination of auditory results that could be discriminatory of patient population versus control group | one month from inclusion |
| Identify potential biomarkers of cochlear synaptopathy |
Inclusion Criteria: All subjects
For amnestic MCI:
Diagnosis of amnestic MCI, according to international diagnosis criteria (NIA-AA, 2011) with MoCA≥23 or MMSE>24.Patients must exhibit predominantly cognitive impairments in episodic memory, defined by a score on the RL/RI 16-item test with a free recall score of less than 18/48 and a total recall score of less than 40/48.
For Parkinson Patients:
Established clinical diagnosis of Parkinson's disease according to Postuma et al. 2015 with bradykinesia associated with resting tremor or rigidity, no exclusion criteria or red flag with MOCA ≥23.
For controls:
No diagnosis of neurological disease such as Parkinson's disease or MCI associated or not with Alzheimer's disease Displays normal cognitive status with a MoCA score ≥ 26.
Non-inclusion criteria:
Known hearing pathologies leading to conductive hearing loss (otosclerosis, a diagnosed pathology of the ear canal, tympanic membrane, ossicles or 3rd window), otitis, congenital deafness or sensorineural hearing loss associated to Menière's disease.
Psychiatric diseases other than neurodegenerative etiology
Neurological or neurovascular disorders (Stroke, epilepsy, dementia)
Motor complications that could interfere with audiological assessment
Known Diagnosis of type 2 diabetes
Alcohol or drug addiction
Cochlear implant
Known ototoxic drug therapy:
History of otological surgical act.
On-going pregnancy or breast-feeding.
Adults protected by law: in vulnerable social situations or unable to express consent.
Under another protocol that may interfere with the analysis of the results.
Exclusion Criteria:
Patients will be excluded from the study if one or more of the following criteria are applicable during visit 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura BREDA, Master's degree | Contact | +33769042226 | laura.breda@cilcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Mathieu SCHUE, PhD | Cilcare SAS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Gui de Chauliac | Recruiting | Montpellier | 34080 | France |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
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Eligibile patients are included and subject to a thorough hearing assessment
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|
As defined by BIAP criteria : ]20-40 dB nHL] = mild ; ]40 - 55] = moderate ; ]55 - 70] = moderately severe ; ]70 - 90] = severe ; ]90 - 120] = profound ;
| within one month from inclusion |
correlations between specific auditory findings and disease parameters |
| one month from inclusion |
| CHU Nice | Recruiting | Nice | 06000 | France |
|
| CHU Carémeau | Recruiting | Nîmes | 30900 | France |
|
| Hospices Civils de Lyon, Hôpital des Charpennes | Recruiting | Villeurbanne | 69100 | France |
|
| D001480 |
| Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |