Neuromod Devices Limited, Dublin, Ireland.
National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, UK.
BMJ Open. 2017 Oct 25;7(10):e018465. doi: 10.1136/bmjopen-2017-018465.
INTRODUCTION: Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. Bimodal neuromodulation is emerging as a promising treatment for this condition. The main objectives of this study are to investigate the relevance of interstimulus timing and the choices of acoustic and tongue stimuli for a proprietary bimodal (auditory and somatosensory) neuromodulation device, as well as to explore whether specific subtypes of patients are differentially responsive to this novel intervention for reducing the symptoms of chronic tinnitus. METHODS AND ANALYSIS: This is a two-site, randomised, triple-blind, exploratory study of a proprietary neuromodulation device with a pre-post and 12-month follow-up design. Three different bimodal stimulation parameter sets will be examined. The study will enrol 342 patients, split 80:20 between two sites (Dublin, Ireland and Regensburg, Germany), to complete 12 weeks of treatment with the device. Patients will be allocated to one of three arms using a stepwise stratification according to four binary categories: tinnitus tonality, sound level tolerance (using loudness discomfort level of <60 dB SL as an indicator for hyperacusis), hearing thresholds and presence of a noise-induced audiometric profile. The main indicators of relative clinical efficacy for the three different parameter sets are two patient-reported outcomes measures, the Tinnitus Handicap Inventory and the Tinnitus Functional Index, after 12 weeks of intervention. Clinical efficacy will be further explored in a series of patient subtypes, split by the stratification variables and by presence of a somatic tinnitus. Evidence for sustained effects on the psychological and functional impact of tinnitus will be followed up for 12 months. Safety data will be collected and reported. A number of feasibility measures to inform future trial design include: reasons for exclusion, completeness of data collection, attrition rates, patient's adherence to the device usage as per manufacturer's instructions and evaluation of alternative methods for estimating tinnitus impact and tinnitus loudness. ETHICS AND DISSEMINATION: This study protocol is approved by the Tallaght Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland, and by the Ethics Committee of the University Clinic Regensburg, Germany. Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences. TRIAL REGISTRATION NUMBER: The trial is registered on ClinicalTrials.gov (NCT02669069) Pre-results.
简介:耳鸣是指在没有相应外部声刺激的情况下感知到声音。双模态神经调节作为一种有前途的治疗方法,正在出现。本研究的主要目的是研究刺激间定时以及声音和舌刺激选择对于专有双模态(听觉和躯体感觉)神经调节设备的相关性,并探讨特定类型的患者是否对这种新的干预措施有不同的反应,以减轻慢性耳鸣的症状。
方法和分析:这是一项在爱尔兰都柏林和德国雷根斯堡的两个地点进行的、随机、三盲、探索性研究,采用前后和 12 个月随访设计。将检查三种不同的双模态刺激参数集。该研究将招募 342 名患者,根据四个二进制类别(耳鸣音调、声音水平耐受(使用响度不适水平<60dB SL 作为超敏的指标)、听力阈值和噪声诱导的听力图特征)按 80:20 的比例在两个地点之间分配到三个臂中的一个。患者将根据四个二进制类别(耳鸣音调、声音水平耐受(使用响度不适水平<60dB SL 作为超敏的指标)、听力阈值和噪声诱导的听力图特征),采用逐步分层法分配到三个臂中的一个,使用响度不适水平<60dB SL 作为超敏的指标)、听力阈值和噪声诱导的听力图特征),采用逐步分层法分配到三个臂中的一个。使用响度不适水平<60dB SL 作为超敏的指标)、听力阈值和噪声诱导的听力图特征),采用逐步分层法分配到三个臂中的一个。三种不同参数集的相对临床疗效的主要指标是两种患者报告的结果测量,即耳鸣障碍量表和耳鸣功能指数,在 12 周的干预后进行测量。通过按分层变量和躯体性耳鸣的存在进行患者亚组划分,进一步探讨临床疗效。将对耳鸣的心理和功能影响的持续效果进行 12 个月的随访。将收集和报告安全性数据。为了为未来的试验设计提供信息,还将进行一些可行性措施,包括:排除原因、数据收集的完整性、失访率、患者对设备使用的依从性(根据制造商的说明)以及评估替代方法来估计耳鸣影响和耳鸣响度。
伦理和传播:本研究方案经爱尔兰都柏林 Tallaght 医院/圣詹姆斯医院联合研究伦理委员会和德国雷根斯堡大学诊所伦理委员会批准。研究结果将通过在同行评议和大众科学期刊上发表文章以及在科学和临床会议上发表演讲,向相关的研究、临床、卫生服务和患者群体传播。
试验注册号:该试验在 ClinicalTrials.gov 上注册(NCT02669069)预结果。
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