Could hearing problems be an early sign of brain disease?
NCT ID NCT07083089
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is looking at hearing in people with early-stage Alzheimer's or Parkinson's disease, compared to healthy volunteers. Researchers will use detailed hearing tests to find out how common different types of hearing loss are, especially 'hidden hearing loss' where standard tests are normal but understanding speech in noisy places is hard. The goal is to learn more about the link between hearing and brain health, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help identify early hearing-related signs of neurodegenerative diseases, leading to better screening tools.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to direct benefits for participants, and findings may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 309 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Carémeau
RECRUITINGNîmes, 30900, France
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CHU Gui de Chauliac
RECRUITINGMontpellier, 34080, France
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CHU Nice
RECRUITINGNice, 06000, France
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Hospices Civils de Lyon, Hôpital des Charpennes
RECRUITINGVilleurbanne, 69100, France
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