Hearing tests in people with early memory or Parkinson's disease changes
Tests hearing in people with early memory loss or Parkinson's disease, compared with healthy people.
Plain-language title generated from the registry record
Registry title: Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Key facts
- Where
- Montpellier, Nice, Nîmes, and Villeurbanne, FranceSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 to 85 with early-stage amnestic mild cognitive impairment or Parkinson's disease, and for people with normal thinking. It studies hearing problems in these groups.
- Age
- 50 to 85 years
- Sex
- Men and women
- Disease stage
- Three groups: amnestic mild cognitive impairment (MoCA 23 or higher, or MMSE above 24); Parkinson's disease with MoCA 23 or higher; or controls with no neurological disease and MoCA 26 or higher.
- Earlier treatment
- Some ear-harming (ototoxic) drugs are not allowed: certain antibiotics and antimalarial drugs in the last 15 days, platinum-based chemotherapy at any time, and high-dose loop diuretics or salicylates.
Main reasons for not taking part
- Known ear conditions causing conductive hearing loss, or a cochlear implant
- Type 2 diabetes
- Stroke, epilepsy or dementia
- Psychiatric disease other than neurodegenerative disease
- Pregnancy or breast-feeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
Source: NCT07083089, who can take part
Where in France
- CHU Gui de ChauliacMontpellier, FranceContact: Audrey GABELLE, MD (principal investigator)Taking people
- CHU NiceNice, FranceContact: Guillaume SACCO, MD (principal investigator)Taking people
- CHU CarémeauNîmes, FranceContact: Cassiana TRANDAFIR, MD (principal investigator)Taking people
- Hospices Civils de Lyon, Hôpital des CharpennesVilleurbanne, FranceContact: Sophie DAUTRICOURT, MD (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Cilcare SAS
- Trial code
- NCT07083089
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
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.
Inclusion: Man or woman aged between 50 and 85 years old at baseline; Fluent in French (native language); 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); Affiliated to Public Health Insurance (Sécurité Sociale); 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:; 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:; Antibiotics: Aminosides IV, macrolides, tetracyclines in the last 15 days prior to inclusion; Antipaludic drugs: quinine, hydroxychloroquine, chloroquine in the last 15 days prior to inclusion; Platinum-based chemotherapy at any time prior to inclusion; Loop diuretics: furosemide (max oral dose of ≤60mg/day) at inclusion and during the study; Salicylate derivatives at high dose (Kardegic allowed at dose ≤320mg/day) at inclusion and during the study; 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: Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (cerumen ear plug, ear drum perforation, …); Patients will be excluded from the study if one or more of the following criteria are applicable during visit 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; Abnormal tympanogram (other type than A); Asymmetric hearing loss: more than 15 dB difference in the pure-tone average (PTA) air conduction (for MCI patients and control group only); Single-sided deafness (SSD); Cophosis (PTAv > 120 dB).