NCT07083089招募中不适用
Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cilcare SAS
- 入组人数
- 309
- 试验地点
- 8
- 主要终点
- Prevalence of hidden hearing loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects
- •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)
- •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 impairments in episodic memory, defined by a score on the RL/RI 16-item test with a free recall score of less than 18/48 and a total recall score of less than 40/
- •For Parkinson Patients:
- •Established clinical diagnosis of Parkinson's disease according to Postuma et al. 2015 with bradykinesia associated with resting tremor or rigidity, no
排除标准
- •or red flag with MOCA ≥
- •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 ≥
- •Non-inclusion criteria:
- •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
- •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)
结局指标
主要结局
Prevalence of hidden hearing loss
时间窗: within one month from inclusion
Percentage of population in each group that displays normal audiometric thresholds (0.5-4kHz) and impaired speech-in-noise intelligibility
次要结局
- Prevalence of sensorineural hearing loss(within one month from inclusion)
- Grade of sensorineural hearing loss(within one month from inclusion)
研究者
研究点 (8)
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