Acupuncture Therapy for Sudden Sensorineural Hearing Loss

Официальное название

Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss：A Multicenter Randomized Controlled Clinical Trial

Обзор

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: 1. Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks. 2. Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper. 3. 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. 4. Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.

Вмешательства

• Процедура Acupuncture
  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
• Процедура Sham acupuncture
  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.

Первичные конечные точки

• Hearing improvement [Срок оценки: Week 8]

Вторичные конечные точки (12)

• Hearing outcomes at multiple time points [Срок оценки: week 1, 2, 4, 8, and 12]
• Word Recognition Score (WRS) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Sudden hearing loss recovery grade [Срок оценки: weeks 1, 2, 4, 8, and 12]
• TCM symptom score [Срок оценки: week 8]
• Sensory Organization Test [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Insomnia Severity Index (ISI) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Dizziness Handicap Inventory (DHI) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Tinnitus Handicap Inventory (THI) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Quality of life (SF-36) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Aural fullness scale (AFS) [Срок оценки: weeks 1, 2, 4, 8, and 12]
• Salvage treatment rate [Срок оценки: day 14]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye and ENT Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07575334 · SSHNL-Acupuncture-Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗