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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Thorough Hearing assessment
Other interventionOtoscopy 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)
Treatment groups
309 Participants
are divided into 3 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Amnestic MCI GroupExperimental treatment 1 intervention
Group C: Parkinson GroupExperimental treatment 1 intervention
Trial outcomes
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
Time frame
within one month from inclusionSecondary outcomes
1
Prevalence of sensorineural hearing loss
Percentage of patients in each group with elevated hearing thresholds (0.5-4kHz)
Time frame
within one month from inclusion2
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 ;
Time frame
within one month from inclusionOther outcomes
1
Explore auditory signatures in neurodegenerative disease patients
Determine combination of auditory results that could be discriminatory of patient population versus control group
Time frame
one month from inclusion2
Identify potential biomarkers of cochlear synaptopathy
correlations between specific auditory findings and disease parameters
Time frame
one month from inclusionSponsors and contacts
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Source ClinicalTrials.gov