Acupuncture Versus Sham Acupuncture for Tinnitus (NCT07700069) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acupuncture Versus Sham Acupuncture for Tinnitus
China226 participantsStarted 2026-07-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
Timeframe: Baseline and Week 5
Trial details
NCT IDNCT07700069
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
. 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.