Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Audiometric tests.
- Кому может быть актуально
- Состояния в реестре: Surdity, the Audiological and Electrophysiological Profile of Hidden Hearing Loss. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Вмешательства
- Диагностический тест Audiometric tests
Audiological and electrophysiological tests will be performed in patients presenting with complaints of hearing difficulties in noisy environments despite normal pure-tone and speech audiometry in quiet.
Первичные конечные точки
- Pure-tone audiometry (air and bone conduction) [Срок оценки: 5 minutes]
- Speech audiometry in quiet [Срок оценки: 10 minutes]
- Framatrix® test (Interacoustics) [Срок оценки: 15 min]
- Transient-evoked otoacoustic emissions (TEOAEs) [Срок оценки: 2 min]
- Distortion product otoacoustic emissions (DPOAEs) [Срок оценки: 5 minutes]
- Electrocochleography [Срок оценки: 10 minutes]
- Auditory brainstem responses (ABR) [Срок оценки: 10 min]
Критерии участия
Критерии включения
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.
-Exclusion criteria :
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 1 центр
- CHU Clermont-Ferrand — Clermont-Ferrand
Идентификаторы
NCT: NCT07738549 · AOI 2023 PUECHMAILLE · 2025-A01827-42