Effect of Cochlear Implant Stimulation on Spatial Orientation in Adult Users
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 主要终点
- Change in spatial orientation performance across three CI conditions as measured by the triangle completion task (TCT), rotational spatial orientation task(RSOT), and virtual spatial orientation task (VSOT).
研究概览
简要总结
The goal of this clinical trial is to learn if cochlear implant activation affects spatial orientation in cochlear implant users. The main question[s] it aims to answer are]:
- Does activation of the cochlear implant improve spatial orientation?
- Is this improvement caused by better hearing ability through the cochlear implant?
Participants will:
- Take an online survey including questions about their cochlear implants and clinical questionnaires on dizziness and spatial orientation
- Undergo balance and spatial orientation tests under different cochlear implant conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years
- •Ability to comply with study procedures
- •Use of a CI (unilateral or bilateral) for minimum 12 months
- •Signed, written informed consent
排除标准
- •Vulnerable individuals
- •Cognitive impairment or altered mental status affecting participation
- •Physical conditions signficantly limiting mobility (e.g. severe gait or muscoskeletal disorders)
结局指标
主要结局
Change in spatial orientation performance across three CI conditions as measured by the triangle completion task (TCT), rotational spatial orientation task(RSOT), and virtual spatial orientation task (VSOT).
时间窗: minimum 1 year post CI implantation procedure.
A repeated measures ANOVA will be conducted for each of the three spatial orientation tasks to test the effect of CI condition on the following dependent variables:TCT - relative and absolute distance error, relative and absolute rotation error. RSOT - relative and absolute angular deviation. VSOT - navigation efficiency, relative time deviation, path length
次要结局
- Point Prevalence of Spatial Orientation Disorders in Cochlear Implant Users(minimum 1 year post CI implantation procedure)