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)
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The MCL threshold, the objective response threshold (eSRT), the eSRT response
概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Incident CI Cohort (Prospective Adults)
Adults ≥18 scheduled for first-time unilateral cochlear implantation within 3 months; followed post-op at M1, M3, M6, M9, M12. Objective measures on ≥3 electrodes (basal, middle, apical): eCAP via CI software; eABR via evoked-potential system; eSRT via tympanometer. No experimental intervention (routine programming only). Main interest: associations between objective metrics and behavioral MCL, with key analyses at M6 and M12.
干预措施: Objective electrophysiological measures (eCAP, eABR, eSRT) (Diagnostic Test)
Prevalent CI Cohort (Cross-Sectional Adults)
Adults ≥18 with unilateral cochlear implant use ≥12 months; single annual follow-up visit. Same objective measures (eCAP, eABR, eSRT) on ≥3 electrodes using standard clinical equipment; no intervention. Purpose: cross-sectional correlations and comparison with the incident cohort.
干预措施: Objective electrophysiological measures (eCAP, eABR, eSRT) (Diagnostic Test)
结局指标
主要结局
The MCL threshold, the objective response threshold (eSRT), the eSRT response
时间窗: 15 months
"The MCL threshold, expressed in CU (charge unit) units, corresponds to the maximum level of stimulation of the implant required to obtain a sound level considered comfortable by the patient. It will be recorded at each post-operative check-up (M1, M3, M6, M9, and M12). The objective response threshold (eSRT), expressed in CU units, corresponds to the minimum level of implant stimulation required to elicit a stapedial reflex. It will be recorded at each post-operative assessment (M1, M3, M6, M9, and M12). The eSRT response will be collected using a tympanometry probe (commonly used to measure ear impedance in patients during a standard hearing assessment) in the patient's external auditory canal, ipsilateral or contralateral to the implanted side. The tympanometer will continuously record ear impedance during electrical stimulation until a significant variation is obtained, indicating the presence of the stapedial reflex."
次要结局
- Correlation between behavioral MCL and eABR threshold(Month 6 and Month 12 post-operative follow-up visits (incident cohort))
- Correlation between behavioral MCL and eCAP threshold(M1, M3, M6, M9, M12 post-operative visits (incident cohort).)
- Correlation between eSRT and eABR thresholds(M6 and M12 post-operative visits (incident cohort).)
- Correlation between eSRT and eCAP thresholds(M1, M3, M6, M9, M12 post-operative visits (incident cohort).)
- Correlation between eABR and eCAP thresholds(Month 6 and Month 12 after cochlear implantation (incident cohort))
- Agreement between intraoperative eSRT by tympanometer vs visual stapedius reflex(ntraoperative (single time point during CI surgery).)
- Probe frequencies eliciting eSRT(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)(From Month 1 to Month 12 after cochlear implantation (incident cohort))
- Cross-sectional associations among MCL and objective measures in prevalent users(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(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.)