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New treatment option for Mild Cognitive Impairment (MCI) Amnestic
Official title Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
ClinicalTrials.gov ID: NCT07083089
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85. Healthy volunteers may be eligible.
You may be able to join if
- All people
- 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...
- Affiliated to Public Health Insurance (Sécurité Sociale)
You likely can't join if
- 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...
- Known hearing pathologies leading to conductive hearing loss (otosclerosis, a diagnosed pathology of the ear canal, tympanic membrane, ossicles or...
- 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
See the full eligibility criteria
- All people
- 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...
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Nice, France
- Nîmes, France
- Villeurbanne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Nice, France; Nîmes, France; Villeurbanne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.