Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)

NCT07083089 | Recruiting

• 1 other identifier: 2024-A01578-39
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Mild Cognitive Impairment (MCI) Amnestic; Parkinson Disease (PD); Healthy Participants

Keywords

hearing phenotype; audiometry; speech-in-noise intelligibility; electrophysiology

Outcome Measures

Primary Outcomes (1)

• 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

  within one month from inclusion

Secondary Outcomes (2)

• Prevalence of sensorineural hearing loss

  within one month from inclusion

• Grade of sensorineural hearing loss

  within one month from inclusion

Other Outcomes (2)

• Explore auditory signatures in neurodegenerative disease patients

  one month from inclusion

• Identify potential biomarkers of cochlear synaptopathy

  one month from inclusion

Study Arms (3)

Control group

OTHER

Control population

Other: Thorough Hearing assessment

Amnestic MCI Group

EXPERIMENTAL

Patients with amnestic mild cognitive impairment

Other: Thorough Hearing assessment

Parkinson Group

EXPERIMENTAL

Patient with parkinson's disease

Other: Thorough Hearing assessment

Interventions

Thorough Hearing assessment OTHER

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)

Amnestic MCI Group; Control group; Parkinson Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• 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:
• 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.
• Patients will be excluded from the study if one or more of the following criteria are applicable during visit 2:

Sponsors & Collaborators

• Cilcare SAS: lead

Study Sites (4)

CHU Gui de Chauliac

Montpellier, 34080, France

RECRUITING

CHU Nice

Nice, 06000, France

RECRUITING

CHU Carémeau

Nîmes, 30900, France

RECRUITING

Hospices Civils de Lyon, Hôpital des Charpennes

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mathieu SCHUE, PhD

  Cilcare SAS

  STUDY DIRECTOR

Central Study Contacts

Laura BREDA, Master's degree

CONTACT

+33769042226; laura.breda@cilcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligibile patients are included and subject to a thorough hearing assessment

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)