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Acupuncture Therapy for Sudden Sensorineural Hearing Loss

Study acronym: SSNHL-Acu
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07575334
Lead Sponsor Eye & ENT Hospital of Fudan University
Conditions
(from sponsor)
Sudden Sensorineural Hearing Loss (SSNHL)
Related terms Hearing Loss, Sudden
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov