Recruiting · registry statusUnderstanding hearing in early Parkinson’s and Alzheimer’s
Researchers compare hearing difficulties in people with early neurological conditions and a comparison group.
Testing a treatment or activity · Study reference: NCT07083089
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Looking for volunteers
- Start (reported actual date)
- 2025-03-24
- Main measurements finished (planned)
- 2026-12
- Study finished (planned)
- 2026-12
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 50 years to 85 years · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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)
Full study name & original research details
Official study title
Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
Short title used by the registry
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
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.
Further description from the registry
A wide battery of subjective and objective hearing tests is performed on the subjects including tonal and vocal audiometry (in silence and in noise), DPOAE, acoustic reflex and electrophysiology recordings (auditory brainstem response, electrocochleography). Hearing tests are correlated to collected disease parameters and blood markers.
Conditions reported: Mild Cognitive Impairment (MCI) Amnestic; Parkinson Disease (PD); Healthy Participants
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Thorough Hearing assessment
- Phases
- NA
- Sponsor
- Cilcare SAS
- Start date reported by registry
- 2025-03-24 (actual)
Registry updated: 2025-12-09 · Status last verified by the registry submitter: 2025-12
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Laura BREDA, Master's degree · +33769042226 · laura.breda@cilcare.com
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
CHU Gui de Chauliac
Montpellier, France
RecruitingAudrey GABELLE, MD
CHU Nice
Nice, France
RecruitingGuillaume SACCO, MD
Aurélie MOUTON, MD
Caroline GIORDANA, MD
CHU Carémeau
Nîmes, France
RecruitingCassiana TRANDAFIR, MD
Giovanni CASTELNOVO, MD
Hospices Civils de Lyon, Hôpital des Charpennes
Villeurbanne, France
RecruitingSophie DAUTRICOURT, MD
Antoine GARNIER CRUSSARD, MD
Fannie BRETELLE, MD
Facility not reported
France
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.