Acupuncture plus steroids for sudden sensorineural hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, randomized controlled trial comparing real acupuncture versus sham acupuncture when both are given alongside a standard oral prednisone course for adults with sudden sensorineural hearing loss. Participants receive acupuncture or sham acupuncture three times per week for four weeks while taking prednisone (1 mg/kg/day, maximum 60 mg/day) with a 7-day taper. The primary outcome is hearing recovery measured by pure tone audiometry at 8 weeks, and secondary outcomes include word recognition, vestibular function, tinnitus, sleep quality, anxiety, and quality of life. Eligible adults are 18–70 years old with unilateral SSNHL of ≥30 dB across at least three consecutive frequencies and must start treatment within 14 days of symptom onset.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Eye and ENT Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Weiming Hao, MD, Doctor
• Email: haoweiming1993@163.com
• Phone: 86-18017321721

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.