NL-OMON23880招募中不适用
Tinnitus and cochlear implantation
Department of Otorhinolaryngology and Head & Neck Surgery University Medical Center Utrecht, Utrecht, The Netherlands0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
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
入选标准
- •Patients aged 18 or older
- •- Seeking help for tinnitus
- •- Subjective tinnitus
- •- Tinnitus Functional Index (TFI) > 32
- •- Tinnitus duration > 1 and tinnitus stability > 6 months
- •- Hearing level (measured with a maximum of 3 months before eligibility assessment):
- •> Audiometry (Pure Tone Average (PTA) at 0.5,1,2,4 kHz): bilateral threshold between 50 and < 75 dB
- •> Hearing threshold stability (PTA < 5 dB change for 1 year in each ear)
- •- Becks Depression Inventory (BDI) <19
- •- 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 1 year before start of the study
- •- 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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