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Could hearing problems be an early sign of brain disease?

NCT ID NCT07083089

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 309 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

50 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Cognitive Dysfunction Parkinson disease

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU Carémeau

    RECRUITING

    Nîmes, 30900, France

  • CHU Gui de Chauliac

    RECRUITING

    Montpellier, 34080, France

  • CHU Nice

    RECRUITING

    Nice, 06000, France

  • Hospices Civils de Lyon, Hôpital des Charpennes

    RECRUITING

    Villeurbanne, 69100, France

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