Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Residual hearing
研究概览
简要总结
This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.
详细描述
Rationale: Preserving residual hearing in cochlear implant (CI) surgery has gained significant attention. It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation, enhancing sound localization, music appreciation, and speech recognition in noisy environments. Using the Cochlear™ Nucleus® CI with Slim Modiolar electrode (Cochlear Ltd., Sydney, Australia), potential sites of residual hearing loss in surgery include approaches to the cochlear lumen, potential damage during entry, and damage during electrode insertion. Studies comparing different surgical approaches (cochleostomy (CO) and extended round window (eRW)) show varied results. Electrocochleography (ECochG) can be used to indicate intracochlear damage during electrode insertion, however, the variability observed in ECochG responses during cochlear implantation remains significant. Moreover, ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery, including the insertion of the sheath or stabilization of the electrode lead.
Objective
The aim of this study is to investigate whether the type of surgical approach to the cochlea; CO or eRW using the CI632 affects the final residual hearing and secondarily, intracochlear trauma and electrode position, as determined by pure tone audiometry, EcochG and imaging.
Study population: Adult CI candidates with post-lingual onset of severe to profound hearing loss, who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of <80 decibel (dB) hearing level at 500 Hz in the ear to be implanted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
- •CI candidate based on local or national reimbursement criteria.
- •Cochlear implantation with a CI
- •Preoperative 500 Hz pure-tone air conduction threshold <80 dB hearing level (HL) in the ear to be implanted.
- •Willing and able to provide written informed consent.
排除标准
- •Previous or existing CI recipient.
- •Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
- •Abnormal cochlear nerve anatomy on preoperative CT or MRI.
- •Subjects who are unable to undergo CT or MRI.
- •Deafness due to acoustic nerve or central auditory pathway lesions.
- •Diagnosis of auditory neuropathy.
- •Active middle ear infection.
- •Additional handicaps that would prevent participation in study evaluations.
- •Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.
- •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
结局指标
主要结局
Residual hearing
时间窗: 3-months postoperatively
The difference in residual hearing per group (eRW or CO) between pre- and postoperative pure tone thresholds, averaged at 500, 750 and 1000 Hz (PTAlow).
次要结局
- Intracochlear electrode position(3-months postoperatively)
- ECochG thresholds after multiple surgery stages(Intraoperatively)