Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Electrode Impedance Development
研究概览
简要总结
This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery.
Adult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety.
The purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.
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
- 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
- 否
入选标准
- •Age 18 years or older
- •Indication for cochlear implantation according to national guidelines
- •Ability to provide written informed consent
排除标准
- •Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician.
结局指标
主要结局
Electrode Impedance Development
时间窗: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.
次要结局
- Behavioural Stimulation Levels(Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively)
- Time to Stable Cochlear Implant Map(At follow-up visits up to 2, 6 and 12 months postoperatively)
- Residual Hearing Preservation(Preoperative baseline and 6 months postoperatively)
- Tinnitus Severity(Through study completion, up to 12 months following cochlear implantation.)
- Cochlear Implant-Related Quality of Life(Through study completion, up to 12 months following cochlear implantation.)
- Patient Experience of Initial Activation(Through study completion, up to 12 months following cochlear implantation.)
- Device- or Wound-Related Complications(Through study completion, up to 12 months following cochlear implantation.)
- Rehabilitation Trajectory(Through study completion, up to 12 months following cochlear implantation.)