Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorCilcare SAS
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Thorough Hearing assessment
Treatment groups
309 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov