RecruitingNot ApplicableNCT07575334

Acupuncture Therapy for Sudden Sensorineural Hearing Loss

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


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

256 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Acupuncture and a procedure called Sham acupuncture for people with sudden sensorineural hearing loss (ssnhl). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAcupuncture

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)

PROCEDURESham 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.


Locations(1)

Eye and ENT Hospital of Fudan University

Shanghai, China

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NCT07575334