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NCT Number: NCT07083089

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Gui de Chauliac, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All subjects

  • 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:

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.

Exclusion criteria

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)

Treatment and study plan

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Prevalence of sensorineural hearing loss

    Time frame: within one month from inclusion

    Percentage of patients in each group with elevated hearing thresholds (0.5-4kHz)

  2. Grade of sensorineural hearing loss

    Time frame: within one month from inclusion

    As defined by BIAP criteria : ]20-40 dB nHL] = mild ; ]40 - 55] = moderate ; ]55 - 70] = moderately severe ; ]70 - 90] = severe ; ]90 - 120] = profound ;

Other outcomes

  1. Explore auditory signatures in neurodegenerative disease patients

    Time frame: one month from inclusion

    Determine combination of auditory results that could be discriminatory of patient population versus control group

  2. Identify potential biomarkers of cochlear synaptopathy

    Time frame: one month from inclusion

    correlations between specific auditory findings and disease parameters

Study contacts

Contact information is provided by the study sponsor or research team.

Laura BREDA, Master's degree

CONTACT

[email protected]

+33769042226

Sponsors and collaborators

Lead sponsor

Cilcare SAS

Industry

Registry information

Official study title

Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)

Acronym: SAPHIR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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