NCT07575334招募中不适用
Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss：A Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
The study aimed to find out how well corticosteroids alone work versus corticosteroids and GCSF together in treating people with severe alcoholic hepatitisCTRI/2024/09/073866Bharati Vidyapeeth Deemed to be University Medical CollegePune60
已完成
4 期
Comparing the Safety and Efficacy of Insulin GLARGINE and DEGLUDEC in Glucocorticoid Induced HYPERGLYCEMIA in Hospitalized Patients".NCT07599891Max Healthcare Insititute Limited79
招募中
2 期
A Study comparing two steroid medicines Hydrocortisone or Dexamethasone for treating patients with severe PneumoniaCTRI/2025/12/099899AIIMS New Delhi126
招募中
4 期
Metycor study2024-514143-28-00Helse Bergen HF100
尚未招募
Phase 3 4
A Clinical Study to see the Impact of MA2/24 and Caffeine vs. Placebo on Mental and Physical StaminaCTRI/2026/01/101999Akay Natural Ingredients Pvt. Ltd25