Trials / Recruiting
RecruitingNCT07083089
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 309 (estimated)
- Sponsor
- Cilcare SAS · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Thorough Hearing assessment | 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) |
Timeline
- Start date
- 2025-03-24
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-07-24
- Last updated
- 2025-12-09
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT07083089. Inclusion in this directory is not an endorsement.