耳鸣是在没有外部刺激的情况下对声音的感知,通常经历为铃声或嗡嗡声。主观耳鸣被认为是由听觉输入减少或缺乏引起的神经活动变化引起的,例如,由于听力损失。由于听觉剥夺被认为是耳鸣的原因之一,通过人工耳蜗植入增加听觉输入可能是一种可能的治疗方法。在评估听力损失患者人工耳蜗植入的研究中,耳鸣缓解被视为次要结果。因此,我们将评估耳蜗植入对主要有耳鸣的患者的影响。
在这项于2021年1月在UMCUtrecht(荷兰)的ENT部门开始的随机对照试验中,主要主诉耳鸣的患者将包括在内。50名患者(耳鸣功能指数(TFI)>32,贝克抑郁指数<19,0.5、1、2和4kHz的纯音平均值:双侧阈值在50和≤75dB之间)将随机接受人工耳蜗植入或无干预。该研究的主要结果是通过TFI测量的耳鸣负担。感兴趣的结果是耳鸣严重程度,听力表现(耳鸣音调和响度,言语感知),生活质量,抑郁症和患者相关的变化。结果将在植入前和手术后3和6个月进行评估。对照组将在随机化后3个月和6个月接受问卷。我们预计耳蜗植入物接受者和对照组之间的耳鸣负担存在显着差异。
本研究方案经大学医学中心(UMC)乌得勒支(NL70319.041.19,V5.0,2021年1月)的机构审查委员会批准。试验结果将在同行评审期刊上向公众开放。
试验注册号NL8693;预结果。
Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.
In this randomised controlled
trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck\'s Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the
study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.
This research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The
trial results will be made accessible to the public in a peer-review journal.
Trial registration number NL8693; Pre-results.