Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AdventHealth
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Low-Frequency Pure Tone Average (LFPTA)
研究概览
简要总结
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use.
The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care.
This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cochlear implant candidates >18 years of age
- •LFPTA (125Hz, 250Hz, 500Hz) <80dB
排除标准
- •Pediatric patients (below the age of 18)
- •LFPTA (125Hz, 250Hz, 500Hz) >80dB
- •Revision cases
- •Severe comorbidities that contraindicate surgery.
- •Preexisting cochlear anomalies.
- •Do not speak English or Spanish
结局指标
主要结局
Change in Low-Frequency Pure Tone Average (LFPTA)
时间窗: Baseline (pre-op) to 12 months post-activation
Change in unaided pure tone thresholds at 125, 250, and 500 Hz from baseline to 12 months post-activation. The average of these frequencies will be computed for each participant.
Speech Recognition Using CNC Word Test
时间窗: 3, 6, and 12 months post-activation
Participants' ability to recognize individual spoken words will be assessed using the Consonant-Nucleus-Consonant (CNC) word test in both quiet and noise conditions. Outcome is based on the percent of key words correctly repeated.
Speech Recognition Using AzBio Sentence Test
时间窗: 3, 6, and 12 months post-activation
Participants' ability to recognize spoken sentences will be assessed using the AzBio sentence test in quiet and noise. Outcome is based on the percent of key words correctly repeated in standardized sentence lists.
Degree of Low-Frequency Hearing Preservation
时间窗: Baseline to 12 months post-activation
Subjects will be categorized based on change in LFPTA into: * Full preservation (\<15 dB loss) * Partial preservation (15-30 dB loss) * Significant loss (\>30 dB loss)
次要结局
- Impedance Measurements(CI activation (6-8 weeks post-op))