NCT03026829终止不适用
"Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cochlear
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
- •At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
- •Native speaker and fluency in the language used in the assessments (i.e. Dutch)
排除标准
- •Additional handicaps that would prevent participation in evaluations
- •History of psychiatric disorders or depression (on investigator's opinion)
- •Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
- •Pulsatile or diagnosed objective / middle ear tinnitus
研究组 & 干预措施
CART sound therapy
Experimental
干预措施: CART sound therapy (Device)
结局指标
主要结局
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
时间窗: week 7
Visual Analogue Scale (VAS) score on tinnitus
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
时间窗: week 7
次要结局
未报告次要终点
研究者
研究点 (2)
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