Acupuncture Therapy for Sudden Sensorineural Hearing Loss (SSNHL-Acu)
Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss:A Multicenter Randomized Controlled Clinical Trial
The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:
Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.
Participants will:
- Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.
- Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper.
- Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12.
- Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Weiming Hao, MD, Doctor
- 电话号码:86-18017321721
- 邮箱:haoweiming1993@163.com
学习地点
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Shanghai、中国
- 招聘中
- Eye and ENT Hospital of Fudan University
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接触:
- Weiming Hao, MD
- 电话号码:86-18017321721
- 邮箱:haoweiming1993@163.com
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首席研究员:
- Yan Chen, PhD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age between 18 and 70 years;
- Meets the diagnostic criteria for sudden sensorineural hearing loss (SSNHL): sudden, unexplained sensorineural hearing loss occurring within 72 hours, with a hearing threshold decrease of ≥30 dB in at least three consecutive frequencies among 250, 500, 1000, 2000, 4000, and 8000 Hz (reference: previous audiologic examination or same frequencies of the contralateral ear);
- Unilateral SSNHL with self-perceived symmetrical hearing in both ears prior to the current episode (or supported by previous audiologic examination reports);
- Time from symptom onset to enrollment and treatment initiation within 14 days;
- Clear consciousness and logical responses, able to understand the scale items and complete the assessments;
- Agrees to participate in the trial and signs a written informed consent form.
Exclusion Criteria:
- Identifiable definite etiology after complete examination, including acoustic neuroma, cerebrovascular accident, trauma, Hunt syndrome, etc.;
- History of hearing abnormality (affected ear) or balance dysfunction prior to the current episode (including previous SSNHL, vestibular migraine, Meniere's disease, benign paroxysmal positional vertigo, congenital/hereditary/syphilitic hearing loss, otosclerosis, etc.);
- Presence of diseases for which systemic corticosteroid therapy is clinically not recommended (e.g., poorly controlled or insulin-dependent diabetes mellitus, history of peptic ulcer, active infection or tuberculosis, history of hepatitis B or C, pancreatitis, severe osteoporosis, osteonecrosis, etc.);
- Received systemic or local corticosteroid therapy for 10 days or more prior to enrollment;
- Presence of other diseases (e.g., severe skin disorders) that preclude completion of acupuncture treatment;
- Presence of severe organ dysfunction;
- Received acupuncture treatment within the past 12 months;
- Pregnant or breastfeeding women;
- Other reasons deemed by the investigator as unsuitable for participation in this clinical study (e.g., high anticipated difficulty in completing follow-up, obvious low compliance, etc.).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Acupuncture combined with corticosteroids group
Participants in this group will receive real acupuncture 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks.
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Main Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally. Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation): External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6) |
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假比较器:Sham acupuncture combined with corticosteroids group
Participants in this group will receive sham acupuncture (applied to the same acupoint locations as in the experimental group, while the needle tip does not penetrate the skin) 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks.
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The same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin.
The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hearing improvement
大体时间:Week 8
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Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group.
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Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hearing outcomes at multiple time points
大体时间:week 1, 2, 4, 8, and 12
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Changes in PTA at weeks 1, 2, 4, 8, and 12
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week 1, 2, 4, 8, and 12
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Word Recognition Score (WRS)
大体时间:weeks 1, 2, 4, 8, and 12
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Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Sudden hearing loss recovery grade
大体时间:weeks 1, 2, 4, 8, and 12
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Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
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weeks 1, 2, 4, 8, and 12
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TCM symptom score
大体时间:week 8
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Change from baseline to week 8 using the pattern-specific TCM symptom scale
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week 8
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Sensory Organization Test
大体时间:weeks 1, 2, 4, 8, and 12
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Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Insomnia Severity Index (ISI)
大体时间:weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Dizziness Handicap Inventory (DHI)
大体时间:weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Tinnitus Handicap Inventory (THI)
大体时间:weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Hospital Anxiety and Depression Scale (HADS)
大体时间:weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Quality of life (SF-36)
大体时间:weeks 1, 2, 4, 8, and 12
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Changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Aural fullness scale (AFS)
大体时间:weeks 1, 2, 4, 8, and 12
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Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12
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weeks 1, 2, 4, 8, and 12
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Salvage treatment rate
大体时间:day 14
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Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
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day 14
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Safety outcome
大体时间:week 8
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Proportion of adverse events in both groups at week 8
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week 8
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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