Hearing profiling in early Alzheimer's and Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants aged 50–85 who are fluent in French will undergo a comprehensive battery of subjective and objective hearing tests, including tonal and speech audiometry in silence and noise, distortion-product otoacoustic emissions (DPOAE), acoustic reflexes, and electrophysiology (auditory brainstem response and electrocochleography). The study specifically looks for speech-in-noise intelligibility deficits despite normal tonal audiograms (so-called hidden hearing loss). Hearing results will be correlated with clinical disease measures and blood biomarkers to search for patterns linked to early neurodegeneration. Healthy control participants are included for comparison and testing is performed at three French university hospital sites.

Why it matters

Who can join: the full rules

Inclusion Criteria: All subjects

1. Man or woman aged between 50 and 85 years old at baseline.
2. Fluent in French (native language)
3. Be considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator (understanding of the information included in the protocol, and requests to realize the investigations, good general health and able to move around).
4. Affiliated to Public Health Insurance (Sécurité Sociale)
5. Signed and dated informed consent form.

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:

1. 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.
2. Psychiatric diseases other than neurodegenerative etiology
3. Neurological or neurovascular disorders (Stroke, epilepsy, dementia)
4. Motor complications that could interfere with audiological assessment
5. Known Diagnosis of type 2 diabetes
6. Alcohol or drug addiction
7. Cochlear implant
8. Known ototoxic drug therapy:

   1. Antibiotics: Aminosides IV, macrolides, tetracyclines in the last 15 days prior to inclusion
   2. Antipaludic drugs: quinine, hydroxychloroquine, chloroquine in the last 15 days prior to inclusion
   3. Platinum-based chemotherapy at any time prior to inclusion.
   4. Loop diuretics: furosemide (max oral dose of ≤60mg/day) at inclusion and during the study.
   5. Salicylate derivatives at high dose (Kardegic allowed at dose ≤320mg/day) at inclusion and during the study.
9. History of otological surgical act.
10. On-going pregnancy or breast-feeding.
11. Adults protected by law: in vulnerable social situations or unable to express consent.
12. 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:

1. Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (cerumen ear plug, ear drum perforation, …)
2. Conductive hearing loss defined by an air-bone threshold gap of 10 dB or greater based on the average of frequencies 0.5, 1, 2, and 4 kHz, and abnormal hearing thresholds (greater than 20 dB HL) for these frequencies.
3. Abnormal tympanogram (other type than A)
4. Asymmetric hearing loss: more than 15 dB difference in the pure-tone average (PTA) air conduction (for MCI patients and control group only)
5. Single-sided deafness (SSD)
6. Cophosis (PTAv \> 120 dB)

Where it's running

• CHU Gui de Chauliac
  Montpellier, France Recruiting
• CHU Nice
  Nice, France Recruiting
• CHU Carémeau
  Nîmes, France Recruiting
• Hospices Civils de Lyon, Hôpital des Charpennes
  Villeurbanne, France Recruiting

Study contacts

• Study coordinator: Laura BREDA, Master's degree
• Email: laura.breda@cilcare.com
• Phone: +33769042226

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.