Same-Day Cochlear Implant Activation (SDA-CI) (SDA-CI)
Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Louise Devantier, MD, PhD
- 电话号码：+45 78450000
- 邮箱：Louise.Devantier@aarhus.rm.dk
学习地点
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Aarhus、丹麦、8200
- Aarhus University Hospital
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接触：
- Louise Devantier, MD, PhD
- 电话号码：+45 7845000
- 邮箱：Louise.Devantier@aarhus.rm.dk
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 years or older
- Indication for cochlear implantation according to national guidelines
- Ability to provide written informed consent
Exclusion Criteria: - 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.
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Same-Day Activation
Participants randomized to this arm will have their cochlear implant activated on the day of surgery once clinically stable.
Following activation, participants will continue with routine cochlear implant programming and rehabilitation according to standard clinical practice.
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Activation of the cochlear implant sound processor on the day of surgery after the participant is fully awake and clinically stable.
Initial activation is performed according to routine clinical practice and followed by standard cochlear implant programming and rehabilitation.
其他名称：
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有源比较器：Standard Day-14 Activation
Participants randomized to this arm will have their cochlear implant activated approximately 14 days after surgery according to current standard clinical practice.
Following activation, participants will continue with routine cochlear implant programming and rehabilitation according to standard clinical practice.
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Activation of the cochlear implant sound processor approximately 14 days after surgery according to current standard clinical practice.
Subsequent programming and rehabilitation follow routine cochlear implant care pathways.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Electrode Impedance Development
大体时间：Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.
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Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Behavioural Stimulation Levels
大体时间：Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming.
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Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Time to Stable Cochlear Implant Map
大体时间：At follow-up visits up to 2, 6 and 12 months postoperatively
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Time from initial cochlear implant activation to achievement of a stable clinical cochlear implant map, defined as no clinically relevant need for further adjustment of stimulation levels at routine programming visits.
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At follow-up visits up to 2, 6 and 12 months postoperatively
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Residual Hearing Preservation
大体时间：Preoperative baseline and 6 months postoperatively
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Change in pure-tone audiometric thresholds following cochlear implantation.
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Preoperative baseline and 6 months postoperatively
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Tinnitus Severity
大体时间：Through study completion, up to 12 months following cochlear implantation.
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Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)
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Through study completion, up to 12 months following cochlear implantation.
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Cochlear Implant-Related Quality of Life
大体时间：Through study completion, up to 12 months following cochlear implantation.
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Quality of life assessed using the QOL-CI-35 questionnaire
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Through study completion, up to 12 months following cochlear implantation.
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Patient Experience of Initial Activation
大体时间：Through study completion, up to 12 months following cochlear implantation.
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Patient-reported experience of first cochlear implant activation and activation-related discomfort assessed using visual analogue scales (VAS)
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Through study completion, up to 12 months following cochlear implantation.
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Device- or Wound-Related Complications
大体时间：Through study completion, up to 12 months following cochlear implantation.
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Frequency of postoperative complications related to the cochlear implant device or surgical wound
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Through study completion, up to 12 months following cochlear implantation.
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Rehabilitation Trajectory
大体时间：Through study completion, up to 12 months following cochlear implantation.
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Duration of rehabilitation and functional rehabilitation level obtained from municipal hearing and communication centres
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Through study completion, up to 12 months following cochlear implantation.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- AUH-CI-SDA-ADULT_2026
- 1-10-72-53-26 (注册表标识符：VEK Region Midt)
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