This multicenter, randomized, sham-controlled clinical trial will evaluate the efficacy and safety of acupuncture for patients with subjective idiopathic tinnitus. A total of 226 eligible participants will be randomly assigned to receive either acupuncture or sham acupuncture. Both groups will receive treatment for 5 weeks. The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus loudness, tinnitus severity, sleep quality, anxiety, depression, audiological assessments, and adverse events. Exploratory neuroimaging outcomes include functional magnetic resonance imaging and magnetoencephalography measures.
Tinnitus as the primary complaint, meeting the diagnostic criteria for subjective idiopathic tinnitus.
Tinnitus duration of at least 6 months.
Patent external auditory canal and intact tympanic membrane.
Bilateral pure tone average no greater than 80 decibels hearing level (dB HL).
Inner ear or auditory nerve disorders, including sudden sensorineural hearing loss, Meniere disease, otosclerosis, or acoustic neuroma.
External or middle ear diseases, including otitis externa, foreign body in the external auditory canal, eczema of the external auditory canal, cerumen impaction, acute or chronic otitis media with effusion, or acute or chronic suppurative otitis media.
Non-otogenic tinnitus caused by acute or chronic systemic diseases involving hematologic, endocrine, renal, or other major organ systems.
Objective tinnitus, including myogenic, vascular, or patulous eustachian tube-related tinnitus.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Collaborator