Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
BMJ Open. 2021 May 18;11(5):e043288. doi: 10.1136/bmjopen-2020-043288.
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.
NL8693; Pre-results.
耳鸣是指没有外部刺激时感知到的声音，通常表现为嗡嗡声或铃声。主观耳鸣被认为源于听觉输入减少或缺失引起的神经活动变化，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，通过耳蜗植入增加听觉输入可能是一种可行的治疗方法。在评估因听力损失而进行耳蜗植入的患者的研究中，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投诉的患者的效果。
本研究为 2021 年 1 月开始在乌得勒支大学医学中心（荷兰）耳鼻喉科进行的一项随机对照试验，将纳入主要抱怨耳鸣的患者。50 名患者（耳鸣功能指数（TFI）32、贝克抑郁指数<19、0.5、1、2 和 4 kHz 纯音平均阈值：双侧阈值在 50 至≤75 dB）将被随机分为耳蜗植入组或无干预组。研究的主要结果是 TFI 测量的耳鸣负担。感兴趣的结果包括耳鸣严重程度、听力表现（耳鸣音调和响度、言语感知）、生活质量、抑郁和患者相关变化。结果将在植入前和手术后 3 个月和 6 个月进行评估。对照组将在随机分组后 3 个月和 6 个月接受问卷调查。我们预计耳蜗植入组与对照组在耳鸣负担方面会有显著差异。
本研究方案已获得乌得勒支大学医学中心机构审查委员会的批准（荷兰 NL70319.041.19，V5.0，2021 年 1 月）。试验结果将在同行评议期刊上向公众公开。
NL8693；预结果。
