Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Cochlear implant electrode location after surgery
研究概览
简要总结
To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are conducting a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.
详细描述
Cochlear implant procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent on extrinsic and intrinsic factors. Significant predictive factors for hearing outcomes in patients with CIs have been previously reported. These include, but are not limited to, duration of deafness, level of preimplant speech recognition, pre/postlingual status, and the coupling of device electrodes. Recipient age does not appear to have a significant impact on hearing outcomes in elderly candidates.
A number of recent studies have proposed that intraoperative factors may be important determinants of electrode location and possibly of audiological outcome. Preliminary reports suggest that intracochlear electrode position- specifically, placement within the ST-is associated with improved audiological outcomes. Additionally, different surgical techniques have been proposed to minimize trauma during electrode insertion and to increase the likelihood of placement within the ST - namely round window and anteroinferior cochleostomy electrode insertion.
Currently, the best surgical approach for electrode insertion is highly debated, fueled by a lack of strong evidence to support one method over another. While a number of CI centers have begun to utilize a round window approach, many large volume centers in the United States and world wide continue to routinely employ cochleostomy electrode insertions. With an increasing number of patients being implanted with greater degrees of residual hearing, such data will become critical towards reducing intracochlear injury and optimizing patient outcomes. To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are initiating a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.
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
- Double (Participant, Investigator)
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
- •18 years of age or older,
- •less than a 10-year duration of deafness in the ear to be implanted,
- •primary surgery,
- •normal shaped cochleae,
- •no retrocochlear pathology, and
- •grossly normal cognitive function.
排除标准
- •less than 18 years of age,
- •prelingual deafness, or
- •greater than 10-years duration of deafness in the ear to be implanted;
- •prior otologic surgery in the implanted ear (excluding tympanostomy tube placement),
- •inner ear malformation present in the ear to be implanted,
- •retrocochlear pathology present in the auditory system to be implanted,
- •developmental delay or known cognitive impairment, or
- •pregnancy.
研究组 & 干预措施
round window
Half of the participants will be randomized to the round window technique of cochlear implant device electrode insertion. Intervention for participants randomized to the round window arm include having the round window technique used for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.
干预措施: Cochlear implant surgery (Procedure)
cochleostomy
Half of the participants will be randomized to the cochleostomy technique of cochlear implant device electrode insertion. For the participants randomized to the cochleostomy arm, the surgeon will use a cochleostomy technique for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.
干预措施: Cochlear implant surgery (Procedure)
结局指标
主要结局
Cochlear implant electrode location after surgery
时间窗: about three months post op
a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea
次要结局
- Participant levels of speech perception(Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively)
- Participant levels of word recognition scores(Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively)
- Participant levels of sentence recognition scores(Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively)