Eye and ENT Hospital of Fudan University
Shanghai, China
Location status: Recruiting
NCT Number: NCT07575334
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Shanghai, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
Time frame: Week 8
Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group.
Time frame: week 1, 2, 4, 8, and 12
Changes in PTA at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
Time frame: week 8
Change from baseline to week 8 using the pattern-specific TCM symptom scale
Time frame: weeks 1, 2, 4, 8, and 12
Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: weeks 1, 2, 4, 8, and 12
Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12
Time frame: day 14
Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14
Time frame: week 8
Proportion of adverse events in both groups at week 8
Contact information is provided by the study sponsor or research team.
Eye & ENT Hospital of Fudan University
Other
Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss:A Multicenter Randomized Controlled Clinical Trial
Acronym: SSNHL-Acu
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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