Acupuncture Therapy for Sudden Sensorineural Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Acupuncture
Procedure/SurgeryMain 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)
Sham acupuncture
Procedure/SurgeryThe 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.
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: Acupuncture combined with corticosteroids groupExperimental treatment 1 intervention
Group B: Sham acupuncture combined with corticosteroids groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hearing improvement
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 8Secondary outcomes
1
Hearing outcomes at multiple time points
Changes in PTA at weeks 1, 2, 4, 8, and 12
Time frame
week 1, 2, 4, 8, and 122
Word Recognition Score (WRS)
Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12
Time frame
weeks 1, 2, 4, 8, and 123
Sudden hearing loss recovery grade
Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria
Time frame
weeks 1, 2, 4, 8, and 124
TCM symptom score
Change from baseline to week 8 using the pattern-specific TCM symptom scale
Time frame
week 8Sponsors and contacts
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Source ClinicalTrials.gov