jRCTs032200430
招募中
不适用
Cochlear implantation for unilateral severe to profound hearing loss
未提供0 个研究点目标入组 38 人开始时间: 待定最近更新:
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 主要终点
- speech perception test by using 67S Japanese monosyllable word table under the SoNnh, SN+0dB noise condition
概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 6age old over 至 No limit（—）
- 性别
- All
入选标准
- •General criteria
- •(1) Patient agreed to participate in the study and signed to the informed consent document.
- •(if patient is a monor, patiens or legal guardians sign to the informed consent document.)
- •(2) Age of 6 years or older when agreed.
- •Audiological criteria
- •(1) The patient withbpost-lingual onset unilateral severe to profound sensorineural hearing loss.
- •(2) The pure tone average (500Hz, 1000Hz, 2000Hz, and 4000Hz) of affected side was 70dBHL or more, or 30% or less speech perception score in affected ear with hearing aid.
- •(3) The onset of hearing loss was 6 months or more and expect the insufficient improvement of hearing ability by conventional treatment.
- •(4) The pure tone average (500Hz, 1000Hz, 2000Hz, and 4000Hz) of contralateral side was 40dBHL oe less.
排除标准
- •The patients with below situations were exclude from this study.
- •(1) Hearing recovery was observed in past 6 month greater than 15dB.
- •(2) Cochear ossification in patients with hearing loss (meningitis, otosclerosis).
- •(3) Severe malformation and cochlear obstraction.
- •(4) Severe outer ear malformation and does not wear audioprosessor.
- •(5) High risk for general anesthesia.
- •(6) Active middle eat infection.
- •(7) Clearly evidenced retro-labryinthine hearing loss adult.
- •(8) Severe mental retardation adult.
结局指标
主要结局
speech perception test by using 67S Japanese monosyllable word table under the SoNnh, SN+0dB noise condition
时间窗: before operation and 12 months after CI fitting
Marked recovery is defined as the average improvement of CI intervention group is significantly better than that of non-treated historical control group (N=17, average improvement: 10.9%, standard deviation: 24.4) by t-test or Wilcoxon signed-rank test.
次要结局
- Marked recovery
研究者
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