NL-OMON54676招募中不适用
Tinnitus implant: Tinnitus and cochlear implantation - Tinnitus and cochlear implantation
niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients aged 18 or older
- •Seeking help for tinnitus
- •Subjective tinnitus
- •Tinnitus Functional Index (TFI) > 32
- •Tinnitus duration > 1 year and subjective tinnitus stability > 6 months
- •Hearing level:
- •o Audiometry (Pure Tone Average (PTA) at 0.5,1,2 kHz): bilateral threshold >= 40
- •and <= 80 dB
- •o Hearing thresholds in the ear to be implanted (>= 4 kHz) >= 50 dB
- •o Hearing threshold stability (PTA < 5 dB change for 1 year in each ear)
- •Health status allows general anesthesia and surgery for the cochlear
- •implantation
- •Failure of regular tinnitus care (e.g. psychological or sound therapy)
- •Dutch language proficiency
- •Willingness and ability to participate in all scheduled procedures outlined
- •in the protocol
- •Able to understand and sign informed consent
排除标准
- •Patient primary seeking help for non-tinnitus hearing problems
- •Abnormal cochlear anatomy(i.e. ossification)
- •Comorbidity with an expected survival of less than five years based on
- •medical history as assessed by clinician and in electronical patient file
- •Additional handicaps that would prevent participation in the evaluations
- •Presence of any instable psychiatric condition within 6 months before start
- •of the study
- •Patient with active clinical depression within the 6 months before start of
- •Unrealistic expectations on the part of the patient regarding the possible
- •benefits, risks and limitations that are inherent to the procedure
研究者
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