An interventional study of Acupuncture and Sham Acupuncture in Tinnitus, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
Subjective idiopathic tinnitus is a common otologic condition that may be associated with sleep disturbance, anxiety, depression, and reduced quality of life. Current treatment options often provide limited symptom relief, and high-quality evidence for acupuncture in tinnitus remains insufficient.
This study is designed as a multicenter, randomized, sham-controlled clinical trial to compare acupuncture with non-penetrating sham acupuncture in patients with chronic subjective idiopathic tinnitus. Eligible participants will be adults aged 18 to 80 years with tinnitus as the primary complaint, tinnitus duration of at least 6 months, and a baseline Tinnitus Handicap Inventory score of 38 or higher.
Participants will be randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group. The acupuncture group will receive standardized acupuncture treatment based on the therapeutic principle of invigorating the spleen, tonifying the kidney, and opening the orifices. The sham acupuncture group will receive non-penetrating sham acupuncture at the same acupoints. Both groups will receive treatment for 5 weeks and tinnitus-related health education.
Participants will be assessed at baseline, during treatment, at the end of treatment, and during post-treatment follow-up. The primary endpoint is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus-related visual analog scale scores, Pittsburgh Sleep Quality Index, Self-Rating Anxiety Scale, Self-Rating Depression Scale, pure tone audiometry, tinnitus matching, distortion product otoacoustic emissions, and adverse events. Exploratory outcomes include changes in brain functional connectivity measured by functional magnetic resonance imaging and brain power spectral density measured by magnetoencephalography.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 226 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive standardized acupuncture treatment twice weekly for 5 consecutive weeks, with 10 sessions in total. Acupuncture will be performed at Tinghui (GB2), Shuaigu (GB8), Taixi (KI3), Taibai (SP3), Yifeng (TE17), and Zhigou (TE6). Needles will be retained for 20 minutes. Participants will also receive tinnitus-related health education.
Procedure: Acupuncture
Participants in this arm will receive non-penetrating sham acupuncture twice weekly for 5 consecutive weeks, with 10 sessions in total. The same acupoints as the acupuncture group will be used. Blunt-tip needles will contact the skin surface without skin penetration or manual needle manipulation. Needles will be retained for 20 minutes. Participants will also receive tinnitus-related health education.
Procedure: Sham Acupuncture
Standardized acupuncture treatment will be administered twice weekly for 5 consecutive weeks, with 10 sessions in total. Acupuncture will be performed at Tinghui (GB2), Shuaigu (GB8), Taixi (KI3), Taibai (SP3), Yifeng (TE17), and Zhigou (TE6). Needles will be inserted according to standardized acupoint locations and retained for 20 minutes. Participants will also receive tinnitus-related health education.
Non-penetrating sham acupuncture will be administered twice weekly for 5 consecutive weeks, with 10 sessions in total. The same acupoints as the acupuncture group will be used. Blunt-tip needles will contact the skin surface without skin penetration or manual needle manipulation. Needles will be retained for 20 minutes. Participants will also receive tinnitus-related health education.
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
The Tinnitus Handicap Inventory is a 25-item questionnaire used to assess tinnitus-related handicap. The total score ranges from 0 to 100, with higher scores indicating more severe tinnitus-related handicap. The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5.
Time frame: Baseline and Week 5
Change in Pittsburgh Sleep Quality Index Score
The Pittsburgh Sleep Quality Index is used to assess sleep quality. Higher scores indicate poorer sleep quality. The change from baseline will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Tinnitus Loudness Visual Analog Scale Score
The tinnitus loudness visual analog scale is used to assess perceived tinnitus loudness. Higher scores indicate greater tinnitus loudness. The change from baseline will be compared between groups.
Time frame: Baseline, immediately after the first treatment session, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Tinnitus Severity Visual Analog Scale Score
The tinnitus severity visual analog scale is used to assess the subjective severity or impact of tinnitus. Higher scores indicate greater tinnitus-related severity or impact. The change from baseline will be compared between groups.
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Self-Rating Anxiety Scale Score
The Self-Rating Anxiety Scale is used to assess anxiety symptoms. Higher scores indicate more severe anxiety symptoms. The change from baseline will be compared between groups.
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Self-Rating Depression Scale Score
The Self-Rating Depression Scale is used to assess depressive symptoms. Higher scores indicate more severe depressive symptoms. The change from baseline will be compared between groups.
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Pure Tone Audiometry Thresholds
Pure tone audiometry will be used to assess hearing thresholds. The change from baseline will be compared between the acupuncture and sham acupuncture groups.
Time frame: Baseline ,week1, Week 5
Change in Tinnitus Matching Loudness
Tinnitus matching loudness will be assessed using audiological testing. The change from baseline will be compared between groups.
Time frame: Baseline ,week1, Week 5
Change in Distortion Product Otoacoustic Emissions
Distortion product otoacoustic emissions will be used to evaluate cochlear outer hair cell function. The change from baseline will be compared between groups.
Time frame: Baseline ,week1, Week 5
Incidence of Adverse Events
All adverse events and treatment-related adverse events will be recorded throughout the study. The incidence of adverse events will be compared between the acupuncture and sham acupuncture groups.
Time frame: From baseline through Week 17
Change in Magnetoencephalography (MEG) Power Spectral Density
Magnetoencephalography will be used as an exploratory neuroimaging outcome to assess changes in brain power spectral density from baseline.
Time frame: Baseline, after the first treatment session, and Week 5
Change in Functional Magnetic Resonance Imaging (fMRI) Functional Connectivity
Functional magnetic resonance imaging will be used as an exploratory neuroimaging outcome to assess changes in brain functional connectivity from baseline.
Time frame: Baseline and Week 5
Plan to share: No — Individual participant data will not be shared because the current ethics approval and informed consent do not include a plan for external sharing of de-identified individual participant data. Aggregate study results may be disseminated through academic publications.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →