Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation

Официальное название

Multimodal Objective Measures Help Cochlear Implant Programming: Cross-sectional and Prospective Study Focusing on the Correlations Between eSRT, Behavioural and Other Objective Responses (eABR, eCAP)

Обзор

Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic. In general, adjustment is based on the patient's responses: the patient must inform the technician of their sensations in order to determine the sound level that is comfortable for them (MCL: maximum comfortable level). The adjustment therefore depends on a subjective assessment. The aim of the adjustments is to make the sound pleasant while increasing the stimulation level to the maximum tolerated level in order to achieve good listening dynamics. Objective indicators would therefore be useful in improving the accuracy of the adjustments. The objective measurements that can be taken are: * Electrical compound action potentials (eCAP) * Electrical auditory brainstem response (eABR) * Electrical stapedius reflex threshold (eSRT).

Подробное описание

Observational study of adult patients who are going to receive or have received a cochlear implant. In fact, two groups of patients will be studied:

Incident case cohort: patients included in the cohort will be followed for one year after surgery.

Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the left, right, and central electrodes. Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) in order to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the basal, median, and apical parts of the electrode array. Stimulation will be configured using the software normally used to adjust the implant.

Responses are collected:

* for eCAPs: via the same software * for eABRs: using an auditory evoked potential recording device synchronized with the implant stimulations * for eSRTs: using a tympanometer with the probe inserted into the external auditory canal on the same side or the opposite side to the stimulation. Cross-sectional sample of prevalent cases: The same measurements will be taken in patients who had a cochlear implant some time ago (evaluation more than one year after surgery). The measurements will be taken only once during their annual check-up. This population will enable us to compare data from patients who have recently had an implant with data from a population that already has a minimum of experience and adaptation to the implant.

Вмешательства

• Диагностический тест Objective electrophysiological measures (eCAP, eABR, eSRT)
  Non-invasive electrophysiological recordings obtained during/after routine cochlear-implant programming, using standard clinical equipment: eCAP via CI software, eABR via an evoked-potential system synchronized with the implant, and eSRT via tympanometry. No investigational device or randomization. Measurements are collected for observational correlations with behavioral levels. Schedule: incident cohort at M1, M3, M6, M9, M12; prevalent cohort single annual visit.

Первичные конечные точки

• The MCL threshold, the objective response threshold (eSRT), the eSRT response [Срок оценки: 15 months]

Вторичные конечные точки (10)

• Correlation between behavioral MCL and eABR threshold [Срок оценки: Month 6 and Month 12 post-operative follow-up visits (incident cohort)]
• Correlation between behavioral MCL and eCAP threshold [Срок оценки: M1, M3, M6, M9, M12 post-operative visits (incident cohort).]
• Correlation between eSRT and eABR thresholds [Срок оценки: M6 and M12 post-operative visits (incident cohort).]
• Correlation between eSRT and eCAP thresholds [Срок оценки: M1, M3, M6, M9, M12 post-operative visits (incident cohort).]
• Correlation between eABR and eCAP thresholds [Срок оценки: Month 6 and Month 12 after cochlear implantation (incident cohort)]
• Agreement between intraoperative eSRT by tympanometer vs visual stapedius reflex [Срок оценки: ntraoperative (single time point during CI surgery).]
• Probe frequencies eliciting eSRT [Срок оценки: Post-operative follow-up visits at Month 1, Month 3, Month 6, Month 9, and Month 12 (incident cohort), and 1 year or more after cochlear implantation (prevalent cohort)]
• Longitudinal profile of objective thresholds (eSRT/eABR/eCAP) [Срок оценки: From Month 1 to Month 12 after cochlear implantation (incident cohort)]
• Cross-sectional associations among MCL and objective measures in prevalent users [Срок оценки: At the annual follow-up visit, at least 12 months after cochlear implant surgery.]
• Between-cohort comparison of correlation coefficients (prevalent vs incident) Description: Comparison of correlation coefficients for each pair (MCL-eSRT, MCL-eABR, MCL-eCAP, eSRT-eABR, eSRT-eCAP, eABR-eCAP) between the prevalent cross-section and the in [Срок оценки: Incident cohort: post-operative follow-up visits from Month 1 through Month 12. Prevalent cohort: annual follow-up visit, at least 12 months after cochlear implant surgery.]

Критерии участия

Критерии включения

Incident case cohort:

• Age ≥ 18 years (18 years or older)
• Scheduled for first-time unilateral cochlear implantation within the next 3 months
• Informed about the study and did not object (non-opposition)

Cross-sectional sample of prevalent cases:

• Age ≥ 18 years (18 years or older)
• Underwent unilateral cochlear implantation more than 1 year ago
• Has used the implant for more than 1 year (interval between implantation surgery and study inclusion > 1 year)
• Informed about the study and did not object (non-opposition)

Критерии исключения

Exclusion Criteria - applies to both the incident case cohort and the cross-sectional sample of prevalent cases:

• Prior middle or inner ear surgery
• Cognitive impairment or insufficient comprehension of French that would prevent understanding of study procedures or accurate measurement of comfort thresholds during programming
• Peripheral facial palsy
• Bilateral cochlear implantation
• Patient under legal guardianship/court-ordered protection

Additional exclusion - cross-sectional sample of prevalent cases only:

\- More than half of the electrodes not inserted (i.e., <50% electrode insertion)

Secondary exclusion criteria - Incident case cohort:

• More than half of the electrodes not inserted (<50% electrode insertion)
• Postoperative peripheral facial nerve palsy following the implantation surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07371299 · APHP250486 · 2025-A01446-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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