Mild Cognitive Impairment (MCI) AmnesticSAPHIRNCT07083089
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
A study testing Thorough Hearing assessment in people with Mild Cognitive Impairment (MCI) Amnestic and Parkinson Disease (PD), run by Cilcare SAS at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI) Amnestic, Parkinson Disease (PD), Healthy Participants
- What is being tested?
- Thorough Hearing assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 29Show fewer
- 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.
Who cannot join
- Patients will be excluded from the study if one or more of the following criteria are applicable during visit 2:
- Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (cerumen ear plug, ear drum perforation, …)
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU Gui de Chauliac
Montpellier, 34080
Audrey GABELLE, MD
- Recruiting
CHU Nice
Nice, 06000
Guillaume SACCO, MD
Aurélie MOUTON, MD
- Recruiting
CHU Carémeau
Nîmes, 30900
Cassiana TRANDAFIR, MD
Giovanni CASTELNOVO, MD
- Recruiting
Hospices Civils de Lyon, Hôpital des Charpennes
Villeurbanne, 69100
Sophie DAUTRICOURT, MD
Antoine GARNIER CRUSSARD, MD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Thorough Hearing assessment
- Keywords
- hearing phenotype, audiometry, speech-in-noise intelligibility, electrophysiology
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thorough Hearing assessmentOther
Otoscopy Tympanometry Tonal audiometry (air and bone conduction) Vocal audiometry (in silence and in noise) Distorsion Products of OtoAcoustic Emissions (DPOAE) Middle Ear Muscle Reflex (MEMR) Auditory Brainstem Response (ABR) Electrocochleography (EcochG)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control population Receives: Other: Thorough Hearing assessment |
| Amnestic MCI Group | Experimental | Patients with amnestic mild cognitive impairment Receives: Other: Thorough Hearing assessment |
| Parkinson Group | Experimental | Patient with parkinson's disease Receives: Other: Thorough Hearing assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hidden hearing loss
Percentage of population in each group that displays normal audiometric thresholds (0.5-4kHz) and impaired speech-in-noise intelligibility
Measured: within one month from inclusion
Secondary outcomes (2)
Prevalence of sensorineural hearing loss
Percentage of patients in each group with elevated hearing thresholds (0.5-4kHz)
Measured: within one month from inclusion
Grade of sensorineural hearing loss
As defined by BIAP criteria : ]20-40 dB nHL] = mild ; ]40 - 55] = moderate ; ]55 - 70] = moderately severe ; ]70 - 90] = severe ; ]90 - 120] = profound ;
Measured: within one month from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start24 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI) AmnesticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Eligibile patients are included and subject to a thorough hearing assessment
- Masking
- None (open label)
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cilcare SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathieu SCHUE, PhD, Study director, Cilcare SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083089
- Sponsor's protocol ID
- 2024-A01578-39
- Acronym
- SAPHIR
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
- ClinicalTrials.gov ID
- NCT07083089
- Acronym / sponsor ID
- SAPHIR / 2024-A01578-39
- Keywords
- hearing phenotype, audiometry, speech-in-noise intelligibility, electrophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Cilcare SASIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eligibile patients are included and subject to a thorough hearing assessment
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Thorough Hearing assessmentControl population |
| Amnestic MCI Group | Experimental | Other: Thorough Hearing assessmentPatients with amnestic mild cognitive impairment |
| Parkinson Group | Experimental | Other: Thorough Hearing assessmentPatient with parkinson's disease |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients will be excluded from the study if one or more of the following criteria are applicable during visit 2:
- Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (cerumen ear plug, ear drum perforation, …)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thorough Hearing assessmentOtoscopy Tympanometry Tonal audiometry (air and bone conduction) Vocal audiometry (in silence and in noise) Distorsion Products of OtoAcoustic Emissions (DPOAE) Middle Ear Muscle Reflex (MEMR) Auditory Brainstem Response (ABR) Electrocochleography (EcochG) | Other | Amnestic MCI Group, Control group, Parkinson Group |
Primary outcome
Prevalence of hidden hearing loss
Time frame: within one month from inclusion
Percentage of population in each group that displays normal audiometric thresholds (0.5-4kHz) and impaired speech-in-noise intelligibility
2 secondary outcomes
Prevalence of sensorineural hearing loss
Time frame: within one month from inclusion
Grade of sensorineural hearing loss
Time frame: within one month from inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu SCHUE, PhD study director
Cilcare SAS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thorough Hearing assessment in people with Mild Cognitive Impairment (MCI) Amnestic and Parkinson Disease (PD), run by Cilcare SAS at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura BREDA, Master's degree (+33769042226, laura.breda@cilcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hidden hearing loss (time frame: within one month from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.