Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Electrocochleography
研究概览
简要总结
This study aims to investigate the underlying mechanisms of speech-in-noise difficulties in patients with normal conventional pure-tone and speech audiometry. Participants presenting with complaints of impaired speech understanding in noisy environments will undergo a comprehensive audiological assessment, including extended high-frequency audiometry, electrocochleography (EcoG), distortion product otoacoustic emissions (DPOAEs), auditory brainstem responses (ABR), and central auditory processing evaluation. The study seeks to identify cochlear, neural, and central auditory abnormalities that may contribute to hidden hearing loss and improve its clinical characterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (age > 18 years). Patients affiliated with a social security/health insurance system. Patients consulting the ENT department for hearing difficulties despite normal conventional pure-tone and speech audiometry performed in quiet.
- •Patients whose native language is French. Patients who have received oral and written information about the study and have provided free and informed consent.
- •Normal otoscopic examination:
- •No external auditory canal obstruction. No history of middle ear surgery (except childhood tympanostomy tube placement).
- •Presence of a translucent tympanic membrane in at least one quadrant, with no tympanic membrane perforation.
- •No signs of active otitis infection. No signs of cholesteatoma. Well-ventilated middle ear cavity confirmed by conventional tympanometry at 226 Hz.
- •- Inclusion criteria for the control group:
- •Adult patients aged between 18 and 25 years. Patients seen during an ENT consultation at Clermont-Ferrand University Hospital, without any hearing complaints.
- •Patients with normal conventional pure-tone audiometry performed in quiet, defined as hearing thresholds between 0 and 20 dB HL across frequencies from 0.25 to 8 kHz, according to BIAP 2017 criteria.
- •No selection bias is expected, as normal hearing is defined as hearing thresholds between 0 and 20 dB HL (BIAP 2017). This age range was selected because it provides the highest likelihood of including individuals with normal auditory function.
排除标准
- •Patients under legal guardianship, curatorship, judicial protection, or deprived of liberty.
- •Pregnant or breastfeeding women. History of language disorders.
- •Abnormal pure-tone audiometry in quiet, defined as:
- •Mean pure-tone hearing loss > 20 dB HL, or At least one frequency threshold > 20 dB HL.
- •Abnormal speech audiometry, defined as:
- •Speech reception threshold on Lafon disyllabic word lists (male voice) > 20 dB HL, and/or Maximum speech intelligibility score of 100% obtained at a level > 40 dB HL. Refusal to participate in the study.
结局指标
主要结局
Electrocochleography
时间窗: 10 minutes
Auditory brainstem responses (ABR)
时间窗: 10 min
Pure-tone audiometry (air and bone conduction)
时间窗: 5 minutes
Speech audiometry in quiet
时间窗: 10 minutes
Framatrix® test (Interacoustics)
时间窗: 15 min
Transient-evoked otoacoustic emissions (TEOAEs)
时间窗: 2 min
Distortion product otoacoustic emissions (DPOAEs)
时间窗: 5 minutes
次要结局
未报告次要终点