改良耳鸣缓解声（MTRS）治疗慢性耳鸣的临床效果：一项随机对照试验方案。
The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial.
机构信息
ENT Institute and Otorhinolaryngology Department of Eye & ENT Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, Shanghai, 200031, People's Republic of China.
NHC Key Laboratory of Hearing Medicine, Fudan University, Shanghai, 200031, People's Republic of China.
出版信息
Trials. 2023 Jun 2;24(1):372. doi: 10.1186/s13063-023-07389-8.
INTRODUCTION
Chronic subjective tinnitus has become an increasingly serious hazard that affects the health-related quality of life for millions of people. Due to the lack of curative treatment strategies, this study aims to introduce a novel acoustic therapy named the modified tinnitus relieving sound (MTRS) for tinnitus and to evaluate the efficacy of MTRS in comparison with unmodified music (UM) which served as a control.
METHODS AND ANALYSIS
A randomized, double-blinded, controlled, clinical trial will be carried out. Sixty-eight patients with subjective tinnitus will be recruited and randomly allocated into two groups in 1:1 ratio. The primary outcome is Tinnitus Handicapped Inventory (THI); the secondary outcomes are the Hospital Anxiety and Distress Scale (HADS; HADS subscales for Anxiety (HADS-A) and Depression (HADS-D)), Athens Insomnia Scale (AIS), the visual analog scale (VAS) for tinnitus, and tinnitus loudness matched by sensation level (SL). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months. Data collected during the intervention process will be analyzed and compared to baseline.
ETHICS AND DISSEMINATION
This trial received ethical approval from the Institutional Review Board (IRB) of Eye & ENT Hospital of Fudan University (No. 2017048). The study results will be disseminated via academic journals and conferences.
FUNDING
This study is supported by the Shanghai Shenkang Development Program (SHDC12019119), the Excellent Doctors-Excellent Clinical Researchers Program (SYB202008), the Shanghai Rising-Star Program (23QC1401200), the Shanghai Rising Stars of Medical Talent Youth Development Program (2021-99), the National Natural Science Foundation of China (81800912), and the National Natural Science Foundation of Shanghai (21ZR1411800).
TRIAL REGISTRATION
ClinicalTrials.gov NCT04026932. Registered on 18 July 2019.
简介
慢性主观性耳鸣已成为影响数百万人健康相关生活质量的日益严重的危害。由于缺乏有效的治疗策略，本研究旨在引入一种新的声学疗法，即改良耳鸣缓解音（MTRS），用于治疗耳鸣，并将其疗效与作为对照的未改良音乐（UM）进行比较。
方法和分析
将开展一项随机、双盲、对照、临床试验。将招募 68 名主观性耳鸣患者，并以 1:1 的比例随机分为两组。主要结局是耳鸣残疾量表（THI）；次要结局是医院焦虑和抑郁量表（HADS；HADS 焦虑分量表（HADS-A）和抑郁分量表（HADS-D））、雅典失眠量表（AIS）、耳鸣视觉模拟量表（VAS）和感觉水平匹配的耳鸣响度（SL）。评估将在随机分组前和随机分组后 1、3、9 和 12 个月进行。声音刺激将持续到随机分组后 9 个月，最后三个月中断。在干预过程中收集的数据将进行分析，并与基线进行比较。
伦理和传播
本试验得到了复旦大学附属眼耳鼻喉科医院机构审查委员会（IRB）的伦理批准（编号：2017048）。研究结果将通过学术期刊和会议进行传播。
资金
本研究得到了上海市申康发展计划（SHDC12019119）、优秀医生-优秀临床研究人员计划（SYB202008）、上海新星计划（23QC1401200）、上海医学人才青年发展计划新星计划（2021-99）、国家自然科学基金（81800912）和上海市自然科学基金（21ZR1411800）的支持。
试验注册
ClinicalTrials.gov NCT04026932。注册于 2019 年 7 月 18 日。
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