Actively Recruiting
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Led by Cilcare SAS · Updated on 2025-12-09
309
Participants Needed
4
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged between 50 and 85 years old at baseline
- Fluent in French (native language)
- Considered reliable and capable of following the study protocol, including understanding information, in good general health, and able to move around
- Affiliated to Public Health Insurance (Sécurité Sociale)
- Signed and dated informed consent form
- For amnestic mild cognitive impairment: diagnosed according to international criteria with MoCA ≥23 or MMSE >24, showing mainly episodic memory impairments defined by specific recall test scores
- For Parkinson patients: clinical diagnosis according to Postuma et al. 2015 with bradykinesia plus resting tremor or rigidity, no exclusion criteria or red flags, and MoCA ≥23
- For control participants: no neurological disease diagnosis such as Parkinson's or MCI, normal cognitive status with MoCA score ≥26
You will not qualify if you...
- Known hearing conditions causing conductive hearing loss, such as otosclerosis, ear canal pathology, tympanic membrane or ossicle problems, 3rd window disorders, otitis, congenital deafness, or Menière's disease-associated sensorineural hearing loss
- Psychiatric diseases unrelated to neurodegenerative causes
- Neurological or neurovascular disorders including stroke, epilepsy, or dementia
- Motor problems that could affect hearing assessments
- Diagnosis of type 2 diabetes
- Alcohol or drug addiction
- Cochlear implant
- Use of known ototoxic drugs recently or during the study, including certain antibiotics, antipaludic drugs, platinum-based chemotherapy, loop diuretics above specified doses, or high-dose salicylates
- History of ear surgery
- Currently pregnant or breastfeeding
- Adults protected by law, vulnerable social situations, or unable to provide consent
- Participation in another protocol that might affect study results
- Abnormal otoscopy with less than 90% of tympanic membrane visible
- Conductive hearing loss defined by specific threshold gaps and hearing levels
- Abnormal tympanogram other than type A
- Asymmetric hearing loss over 15 dB difference in pure-tone average for MCI and controls
- Single-sided deafness
- Severe hearing loss (PTAv > 120 dB)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
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