Acoustic stimulation treatment for chronic tinnitus
Clinical Study on Acoustic Stimulation Intervention in Chronic Tinnitus Patients
This trial will try acoustic sound stimulation to reduce ringing for adults whose tinnitus has lasted six months or longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07185061 on ClinicalTrials.gov |
What this trial studies
This interventional protocol delivers targeted acoustic stimulation to adults with chronic tinnitus and no structural ear lesions. Eligible participants must have had tinnitus for more than six months, be mentally stable, and be off other tinnitus treatments for at least three months. Patients with middle ear disease, temporal bone lesions, recent ototoxic drug exposure, or central nervous system disorders are excluded. Treatments and follow-up are conducted at a single center in Nanjing, with symptom changes used to judge effect.
Who should consider this trial
Good fit: Adults with chronic tinnitus lasting over six months, mentally alert and stable, without organic lesions of the auditory pathway or temporal bone, and who have not used other tinnitus therapies for at least three months.
Not a fit: Patients with otologic structural disease, active middle ear conditions, recent use of tinnitus medications or ototoxic drugs, or central nervous system disorders are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could lessen perceived tinnitus and improve daily functioning for some patients.
How similar studies have performed: Prior sound-based therapies such as notched music and acoustic neuromodulation have produced modest benefit for some people, but results across studies have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronic tinnitus lasting over six months (with or without hearing loss), showing no organic lesions in the auditory conduction pathway or temporal bone, and either not receiving any treatment (including medication or traditional Chinese medicine) or having discontinued therapy for over three months. These patients must be mentally alert, mentally stable, and able to provide fluent responses to all questions from the doctor and research team members. Exclusion Criteria: * Patients with organic lesions in the auditory conduction pathway and temporal bone (e.g., tympanic membrane perforation, ossicular chain disruption), other otological conditions such as Meniere's disease, vertigo, chronic otitis media, middle ear cholesteatoma, or acute/chronic external otitis, history of head trauma or central nervous system disorders, exposure to ototoxic drugs, use of tinnitus medications or traditional Chinese medicine treatments (within 3 months of discontinuation), inability to cooperate with medical procedures or answer questions, or participants who dropped out or lost contact within 3 months.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Lei Cheng, PhD，MD
- Email: chenglei@jsph.org.cn
- Phone: +86 13776620807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.