Actively Recruiting
Acupuncture Therapy for Sudden Sensorineural Hearing Loss
Led by Eye & ENT Hospital of Fudan University · Updated on 2026-05-08
256
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acupuncture Therapy for Sudden Sensorineural Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosed with sudden sensorineural hearing loss (SSNHL) occurring within 72 hours with hearing loss of 30 dB or more in three consecutive frequencies
- Unilateral SSNHL with previously symmetrical hearing in both ears
- Symptom onset to treatment initiation within 14 days
- Clear consciousness and able to understand and complete assessments
- Signed informed consent to participate
You will not qualify if you...
- Confirmed causes such as acoustic neuroma, stroke, trauma, or Hunt syndrome
- History of hearing or balance problems before this episode
- Diseases contraindicating corticosteroid therapy (e.g., uncontrolled diabetes, peptic ulcer, active infection, hepatitis B or C, pancreatitis, severe osteoporosis)
- Received corticosteroid treatment for 10 days or more before enrollment
- Diseases preventing completion of acupuncture (e.g., severe skin disorders)
- Severe organ dysfunction
- Acupuncture treatment within past 12 months
- Pregnant or breastfeeding women
- Other reasons making participation unsuitable, such as low compliance or difficulty completing follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eye and ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
W
Weiming Hao, MD, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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