TinnitusNCT07700069
Acupuncture Versus Sham Acupuncture for Tinnitus
A study testing Acupuncture in people with Tinnitus, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 3 sitesChina
- Study dates
- 10 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200011
Yun Li, MD, 0086-021-021-63138341, liyuncmm@126.com
Yu G Liu, PHD
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Hui J Lan, MD, 0086-021-64385700, lanjh_ent@163.com
Hui J Lan, MD
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Ling J Zhang, PHD, 0086-021-65161782, eternityz@sina.com
Ying J Tan, MD
About this study
Official title: Efficacy and Safety of Acupuncture Versus Sham Acupuncture in the Treatment of Tinnitus: A Randomized Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Tinnitus
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Subjective Idiopathic Tinnitus, Acupuncture, Sham Acupuncture, Randomized Controlled Trial, Tinnitus Handicap Inventory, Magnetoencephalography
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
Sham AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Procedure: Acupuncture |
| Sham Acupuncture | Sham comparator | 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. Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 5
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline through Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized in a 1:1 ratio to receive either acupuncture or sham acupuncture. Both groups will receive treatment for 5 weeks and will be followed during and after treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, Longhua Hospital
- Responsible party
- Sponsor
- Investigators
- Yun Li, MD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700069
- Sponsor's protocol ID
- SH9H-2026-T202-1
- Other IDs
- 2025CROC07
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture Versus Sham Acupuncture in the Treatment of Tinnitus: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07700069
- Acronym / sponsor ID
- SH9H-2026-T202-1
- Conditions
- Tinnitus
- Keywords
- Subjective Idiopathic Tinnitus, Acupuncture, Sham Acupuncture, Randomized Controlled Trial, Tinnitus Handicap Inventory, Magnetoencephalography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, Longhua Hospital
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized in a 1:1 ratio to receive either acupuncture or sham acupuncture. Both groups will receive treatment for 5 weeks and will be followed during and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureParticipants 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. |
| Sham Acupuncture | Sham comparator | Procedure: Sham AcupunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureStandardized 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. | Procedure or surgery | Acupuncture |
| Sham AcupunctureNon-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. | Procedure or surgery | Sham Acupuncture |
Primary outcome
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
Time frame: Baseline and 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.
9 secondary outcomes
Change in Pittsburgh Sleep Quality Index Score
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Tinnitus Loudness Visual Analog Scale Score
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
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Self-Rating Anxiety Scale Score
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Self-Rating Depression Scale Score
Time frame: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
Change in Pure Tone Audiometry Thresholds
Time frame: Baseline ,week1, Week 5
Change in Tinnitus Matching Loudness
Time frame: Baseline ,week1, Week 5
Change in Distortion Product Otoacoustic Emissions
Time frame: Baseline ,week1, Week 5
Incidence of Adverse Events
Time frame: From baseline through Week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun Li, MD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Tinnitus, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Li, MD (0086-021-63138341, liyuncmm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5 (time frame: Baseline and Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.