Actively Recruiting
Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
Led by Cilcare SAS · Updated on 2025-12-09
309
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying hearing characteristics in people aged 50 to 85 with early-stage neurodegenerative disorders, including Alzheimer's and Parkinson's disease. The study focuses especially on those who have trouble understanding speech in noisy environments despite normal hearing tests, known as hidden hearing loss. The goal is to explore how common various hearing problems are in these patients compared to healthy individuals and to identify possible related biomarkers. Participants undergo a wide range of hearing tests such as tonal and vocal audiometry in silence and noise, distortion product otoacoustic emissions, middle ear muscle reflex, auditory brainstem response, and electrocochleography. These tests are combined with disease-related data and blood marker analysis. Study groups include healthy controls, patients with amnestic mild cognitive impairment, and patients with Parkinson's disease. During the study, participants will have hearing assessments and provide health information and blood samples. Researchers measure the prevalence and degree of hidden and sensorineural hearing loss within one month of enrollment. The study involves no randomization or blinding. Participants are monitored for up to one month after inclusion, and safety and hearing function are carefully evaluated. The entire participation period is relatively short, focusing on detailed hearing phenotyping and associated biomarkers.
CONDITIONS
Brief Title
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman aged between 50 and 85 years old at baseline.
- Fluent in French (native language).
- Considered reliable and capable of following the study protocol.
- Affiliated to Public Health Insurance (S�e9curit�e9 Sociale).
- Signed and dated informed consent form.
- For amnestic MCI: diagnosis according to international criteria with MoCA �b7�b723 or MMSE >24 and specific memory impairment scores.
- For Parkinson patients: clinical diagnosis with bradykinesia and tremor or rigidity, and MoCA �b7�b723.
- For controls: no neurological disease and normal cognitive status with MoCA �b7�b726.
You will not qualify if you...
- Known hearing pathologies causing conductive hearing loss or specific ear diseases.
- Psychiatric diseases other than neurodegenerative types.
- Neurological or neurovascular disorders such as stroke, epilepsy, or dementia.
- Motor complications impacting hearing tests.
- Diagnosis of type 2 diabetes.
- Alcohol or drug addiction.
- Presence of cochlear implant.
- Use of ototoxic drugs recently or during study.
- History of ear surgery.
- Pregnancy or breastfeeding.
- Adults protected by law or unable to consent.
- Participation in other interfering protocols.
- Abnormal otoscopy or tympanogram.
- Conductive or asymmetric hearing loss.
- Single-sided deafness or severe hearing loss (cophosis).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Trial Site Locations
Total: 4 locations
1
CHU Gui de Chauliac
Montpellier, France, 34080
Actively Recruiting
2
CHU Nice
Nice, France, 06000
Actively Recruiting
3
CHU Carémeau
Nîmes, France, 30900
Actively Recruiting
4
Hospices Civils de Lyon, Hôpital des Charpennes
Villeurbanne, France, 69100
Actively Recruiting
Research Team
L
Laura BREDA, Master's degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here