Acupuncture Versus Sham Acupuncture for Tinnitus

Starting soon · Not applicable · Has a placebo group

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT07700069

Run by

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

People needed

226

Starts

2026-07-10

Expected to finish

2027-03-31

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• No contraindications to MRI or MEG scanning, such as claustrophobia or metallic implants.
• Age 18 to 80 years.
• Right-handed.
• Baseline Tinnitus Handicap Inventory score of 38 or higher.
• Able to understand and complete examinations, assessments, and treatment procedures under physician guidance.
• Willing to participate and able to provide written informed consent before treatment.

You may not qualify if…

• 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.
• Cognitive impairment or tinnitus caused by other neurological diseases, including stroke, epilepsy, traumatic brain injury, severe headache history, severe central ischemia, brain tumor, neurasthenia, or post-neurosurgical tinnitus.
• Severe cardiovascular or cerebrovascular disease, intracranial space-occupying disease, tumor, or severe pulmonary, hepatic, renal, or hematopoietic disease.
• Pregnancy or lactation.
• Psychiatric disease, impaired consciousness, or inability to cooperate with examinations or treatment.
• Participation in another conflicting clinical trial within 6 months before enrollment or currently participating in another conflicting clinical trial.

Where it is running

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China
• Longhua Hospital, Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China
• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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