Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
Recruiting now · Not applicable
Conditions studied: Mild Cognitive Impairment (MCI) Amnestic, Parkinson Disease (PD), Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT07083089
- Run by
- Cilcare SAS
- People needed
- 309
- Starts
- 2025-03-24
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-09
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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)
Where it is running
- CHU Gui de Chauliac — Montpellier, France (enrolling)
- CHU Nice — Nice, France (enrolling)
- CHU Carémeau — Nîmes, France (enrolling)
- Hospices Civils de Lyon, Hôpital des Charpennes — Villeurbanne, France (enrolling)
Full record on ClinicalTrials.gov
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