NCT07083089Recruiting
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 309 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 24 Mar 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Cilcare SAS
- Diseases
- Alzheimer disease, Parkinson disease
- NCT number
- NCT07083089
What you commit to
- Study type: Interventional
- Planned participants: 309
- From 24 Mar 2025 to the primary completion date, Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (cerumen ear plug, ear drum perforation, …)
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Gui de Chauliac Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| CHU Carémeau Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hospices Civils de Lyon, Hôpital des Charpennes Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.