单侧耳聋患者耳鸣减轻情况：在一项随机对照试验中对人工耳蜗植入、骨传导装置及对侧声音路由助听器的效果进行研究
Tinnitus reduction in patients with single-sided deafness: the effect of cochlear implantation, bone conduction devices, and contralateral routing of sound hearing aids investigated in a randomized controlled trial.
作者信息
Wendrich Anne W, Assouly Kelly K S, van Heteren Jan A A, Peters Jeroen P M, Grolman Wilko, Stokroos Robert J, Versnel Huib, Smit Adriana L
机构信息
Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, Netherlands.
出版信息
Front Neurol. 2024 Jul 23;15:1428106. doi: 10.3389/fneur.2024.1428106. eCollection 2024.
OBJECTIVES
Single-sided deafness (SSD) is often accompanied by tinnitus, resulting in a decreased quality of life. Currently, there is a lack of high level of evidence studies comparing different treatment options for SSD regarding tinnitus reduction. This randomized controlled trial (RCT) evaluated the effect of a cochlear implant (CI), bone conduction device (BCD), contralateral routing of sound (CROS), and no treatment on tinnitus outcomes in SSD patients, with follow-up extending to 24 months.
METHODS
A total of 120 adult SSD patients were randomized to three groups: CI, a trial period with first a BCD on a headband, then a CROS, or vice versa. After the trial periods, patients opted for a BCD, CROS, or no treatment. At the start of follow-up, 28 patients were implanted with a CI, 25 patients with a BCD, 34 patients had a CROS, and 26 patients chose no treatment. The Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire (TQ), the Visual Analog Scale (VAS), and the Hospital Anxiety and Depression Scale (HADS) were completed at baseline and at 3, 6, 12, and 24 months of follow-up.
RESULTS
The CI and BCD groups showed significantly decreased tinnitus impact scores. The CI group showed the largest decrease, which was already observed at 3 months of follow-up. Compared to the baseline, the median THI score decreased by 23 points, the TQ score by 17 points, and the VAS score by 60 points at 24 months. In the BCD group, the TQ score decreased by 9 points, and the VAS decreased by 25 points at 24 months. The HADS anxiety and depression subscale showed no indication for anxiety or depression at baseline, nor at 24 months, for all groups.
CONCLUSION
In this RCT, SSD patients treated with a CI or BCD showed an overall decrease in tinnitus impact scores up to 24 months compared to baseline. The CI group reported a stable and the largest reduction. Cochlear implants appear to be superior to BCD and CROS, and no treatment for achieving partial or complete resolution of tinnitus in patients with SSD.
CLINICAL TRIAL REGISTRATION
Netherlands Trial Register, www.onderzoekmetmensen.nl/nl/trial/26952, NTR4457, trial.
目的
单侧耳聋（SSD）常伴有耳鸣，导致生活质量下降。目前，缺乏关于比较不同SSD治疗方案对耳鸣减轻效果的高水平证据研究。这项随机对照试验（RCT）评估了人工耳蜗（CI）、骨传导装置（BCD）、对侧声音路由（CROS）以及不治疗对SSD患者耳鸣结局的影响，随访期延长至24个月。
方法
共120例成年SSD患者被随机分为三组：CI组、先使用头带式BCD然后使用CROS的试验期组，或反之的试验期组。试验期结束后，患者选择BCD、CROS或不治疗。在随访开始时，28例患者植入了CI，25例患者使用BCD，34例患者使用CROS，26例患者选择不治疗。在基线以及随访的3、6、12和24个月时完成耳鸣障碍量表（THI）、耳鸣问卷（TQ）、视觉模拟量表（VAS）以及医院焦虑抑郁量表（HADS）。
结果
CI组和BCD组的耳鸣影响评分显著降低。CI组降低幅度最大，在随访3个月时就已观察到。与基线相比，在24个月时，CI组的THI中位数评分降低了23分，TQ评分降低了17分，VAS评分降低了60分。在BCD组，24个月时TQ评分降低了9分，VAS降低了25分。所有组在基线时以及24个月时，HADS焦虑和抑郁子量表均未显示焦虑或抑郁迹象。
结论
在这项RCT中，与基线相比，接受CI或BCD治疗的SSD患者在长达24个月的时间里耳鸣影响评分总体下降。CI组报告的下降稳定且幅度最大。对于实现SSD患者耳鸣部分或完全缓解，人工耳蜗似乎优于BCD、CROS以及不治疗。
临床试验注册
荷兰试验注册库，www.onderzoekmetmensen.nl/nl/trial/26952，NTR4457，试验。
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