Acupuncture Versus Sham Acupuncture for Tinnitus

NCT07700069 | Not Yet Recruiting DMC

• 2 other identifiers: SH9H-2026-T202-12025CROC07
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Tinnitus

Keywords

Subjective Idiopathic Tinnitus; Acupuncture; Sham Acupuncture; Randomized Controlled Trial; Tinnitus Handicap Inventory; Magnetoencephalography

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 5

Secondary Outcomes (9)

• Change in Pittsburgh Sleep Quality Index Score

  Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17

• Change in Tinnitus Loudness Visual Analog Scale Score

  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

  Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17

• Change in Self-Rating Anxiety Scale Score

  Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17

• Change in Self-Rating Depression Scale Score

  Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17

Other Outcomes (2)

• Change in Magnetoencephalography (MEG) Power Spectral Density

  Baseline, after the first treatment session, and Week 5

• Change in Functional Magnetic Resonance Imaging (fMRI) Functional Connectivity

  Baseline and Week 5

Study Arms (2)

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.

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.

Procedure: Sham Acupuncture

Interventions

Acupuncture PROCEDURE

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.

Acupuncture

Sham Acupuncture PROCEDURE

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (3)

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

Shanghai, Shanghai Municipality, 200011, China

Location

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yun Li, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Li, MD

CONTACT

0086-021-63138341; liyuncmm@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be masked to group allocation. Acupuncturists cannot be masked due to the nature of the intervention. Randomization personnel will not participate in treatment, outcome assessment, or statistical analysis. Data analysts will remain blinded until the primary analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)