Acupuncture Therapy for Sudden Sensorineural Hearing Loss (SSNHL-Acu)

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Sudden Sensorineural Hearing Loss (SSNHL)

Treatments: Procedure: Sham acupuncture; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07575334

SSHNL-Acupuncture-Trial

Details and patient eligibility

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• Clear consciousness and logical responses, able to understand the scale items and complete the assessments;
• Agrees to participate in the trial and signs a written informed consent form.

Exclusion criteria

• 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;
• Presence of other diseases (e.g., severe skin disorders) that preclude completion of acupuncture treatment;
• Presence of severe organ dysfunction;
• Received acupuncture treatment within the past 12 months;
• Pregnant or breastfeeding women;
• Other reasons deemed by the investigator as unsuitable for participation in this clinical study (e.g., high anticipated difficulty in completing follow-up, obvious low compliance, etc.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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256 participants in 2 patient groups

Acupuncture combined with corticosteroids group

Experimental group

Description:

Participants in this group will receive real acupuncture 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks.

Treatment:

Procedure: Acupuncture

Sham acupuncture combined with corticosteroids group

Sham Comparator group

Description:

Participants in this group will receive sham acupuncture (applied to the same acupoint locations as in the experimental group, while the needle tip does not penetrate the skin) 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks.

Treatment:

Procedure: Sham acupuncture