Single-Center, Single-arm, Open, Prospective, Pivotal Clinical Trial for Evaluating the Audiological Efficacy and Safety of Sullivan Cochlear Implantation in Patients With Severe to Profound Bilateral Hearing Loss.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Change in open-set sentence recognition
研究概览
简要总结
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
详细描述
This study is a clinical trial designed to examine the auditory performance improvement in patients with bilateral severe sensorineural hearing loss (70 dB HL or greater) by comparing auditory performance before and after cochlear implant surgery.
Cochlear implants, both imported and domestically manufactured, have already been approved and are in use in the country. These existing devices have also undergone clinical research, comparing and analyzing auditory performance before and after implantation. Therefore, this study is designed as a prospective, single-arm, open-label clinical trial.
Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments.
Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with sensorineural hearing loss of 1 side or both sides (70 dBHL) or higher, aged 19 years or older
- •No previous cochlear implantation history in the ear scheduled for surgery
- •No contraindications to surgery, such as cochlear agenesis or auditory nerve agenesis, as determined by imaging tests
- •Patients without cancer, autoimmune disease, or neurological disease
- •Patients with a general condition that allows general anesthesia
- •Patients with no abnormalities in personality, depression, anxiety, sociality, or problem drinking tests
- •Use Korean
- •Patients who agree to participate in the clinical trial and sign a written consent form However, if the patient is unable to sign, the patient (if able to sign) and guardian (or agent) voluntarily agree to participate in the clinical trial and sign an informed consent form
排除标准
- •Cases where electrode insertion is difficult due to severe internal malformation, cochlear ossification, etc.
- •Cases with cancer or autoimmune disease
- •Cases with a general condition that makes it difficult to tolerate general anesthesia
- •Cases with moderate or higher mental disability or where auditory training is difficult due to the absence of parents or supporters to assist with rehabilitation education
- •Cases deemed inappropriate for this test by the clinical trial manager
结局指标
主要结局
Change in open-set sentence recognition
时间窗: at 12-week and 24-week post-implant
Sentences will be presented before the implant surgery, and at 12- and 24-weeks post implant, to assess and record the patient's sentence recognition ability. A total of 10 sentences, comprising 50 words, will be used for this evaluation. For each sentence, the percentage of correctly recognized words will be calculated out of the total 50 words across the 10 sentences. Sentence recognition abilities for each participant will be assessed at pre-surgery, 12 weeks, and 24 weeks. Improvement in sentence recognition at 12 weeks and 24 weeks will be determined by comparing these post-implant scores with pre-surgery scores.
次要结局
- Change in open-set monosyllabic word recognition(at the 12-week and 24-week post-implant)
- Change in open-set bisyllabic word recognition(at the 12-week and 24-week post-implant)
- Change in pure-tone hearing thresholds(at the 12-week and 24-week post implant)