Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.

Официальное название

BREEDBAND TYMPANOMETRIE ALS EEN NIET-GEDRAGSMATIGE TEST VAN DE SPRAAK-GEWOGEN MIDDENOOR TRANSFER FUNCTIE.

Обзор

There is a need for a non-behavioral clinical test that provides an assessment of how speech is conducted through the middle ear for the optimization of middle ear implants. These implants utilize the functionality of the human middle ear and require adequate speech conduction through the middle ear chain. Consequently, the clinical test of this degree of speech transfer can contribute to the pre-operative indication for middle ear implants. Wideband Tympanometry (WT) is a non-invasive diagnostic tool for the clinical assessment of the condition of the middle ear. Unlike classical tympanometry, WT tests the impedance of the middle ear system as a function of both pressure and frequencies. Consequently, a WT measurement contains many times more information about the functionality of the middle ear than classical tympanometry and is ideally suited as a diagnostic tool for the clinical assessment of speech transfer through the middle ear. The WT measurements will be correlated with the Speech Intelligibility Index (SII) collected in normally hearing individuals and patients with isolated conductive hearing loss. This index is a measure of speech transfer through the middle ear. Consequently, a correlation of the WT measurements with the SII addresses the need for a non-behavioral clinical test of speech transfer through the middle ear. Additionally, WT measurements will be performed longitudinally in cochlear implant candidates, one of the populations that can benefit from the developed clinical test. These longitudinal WT measurements, which will be performed both pre- and post-operatively, allow for the evaluation of the impact of middle ear surgery on the predicted SII.

Вмешательства

• Устройство Wideband Tympanometry
  Wideband Tympanometry evaluates the condition of the middle ear by measuring the middle ear's acoustic response in function of pressure and frequency. To this end, a probe containing a speaker, microphone and pressure pomp is gently inserted into the external ear canal. Tests are performed with a CE approved device.

Первичные конечные точки

• Wideband Absorbance as measured with Wideband Tympanometry [Срок оценки: 5 minutes]

Критерии участия

Критерии включения

• NH subjects
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the ICF.
• Pure tone audiometry:
• Air-conduction hearing threshold at all frequencies ≤15dB.
• No air-bone-gap.
• Normal classical tympanometry: Jerger A (see fig. 1)
• CHL subjects
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the ICF.
• Pure tone audiometry:
• Bone-conduction threshold at all frequencies ≤20dB.
• Two exceptions:

• Age-related hearing loss: bone-conduction threshold ≤40dB in the higher frequencies (> 2kHz).
• Carhart notch: bone-conduction threshold >20dB around 2kHz. air-bone-gap ≥10dB at ≥ 1 frequency.
• CI recipients
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the ICF.
• Ear is planned for CI surgery by treating ENT surgeon.
• Normal classical tympanometry: Jerger A.

Критерии исключения

• NH subjects
• Patient has history of extensive middle ear disease.
• Patient has history of middle ear surgery.
• Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion.
• Severe otitis externa or occlusion of the external auditory canal
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• CHL subjects
• Patient has history of middle ear surgery.
• Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion.
• Signs of structural pathological processes such as tumors, cysts or cholesteatoma.
• Severe otitis externa or occlusion of the external auditory canal
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• CI recipients
• ear has history of extensive middle ear disease.
• ear has history of middle ear surgery.
• Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion.
• Severe otitis externa or occlusion of the external auditory canal

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 1 центр

• UZ Leuven — Leuven

Идентификаторы

NCT: NCT07557771 · S70272 · 1S16625N · 1804826N · HBC.2023.0899

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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