Actively Recruiting
Clinical Study on Acoustic Stimulation Intervention in Chronic Tinnitus Patients
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-09-22
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic tinnitus is the perception of sound without any external source lasting six months or more, affecting a significant portion of the global population. It often disrupts hearing and daily life, with many patients requiring medical treatment. Researchers are exploring a new approach called Active Tinnitus Stimulation Therapy (ATST), which targets brain mechanisms involved in tinnitus, aiming to reduce abnormal neuronal activity through personalized acoustic stimulation. The study evaluates the use of acoustic stimulation tailored to each patient’s hearing loss and tinnitus features. This device-generated therapy converts specific sound signals into electrical impulses that modulate auditory pathways and neurons. The therapy is adjusted based on patient responses to find the most comfortable sound range. The intervention period lasts 12 weeks, focusing on active neuromodulation to reduce tinnitus perception. Participants will undergo assessments including the Tinnitus Handicap Inventory, anxiety, depression, and sleep quality scales from enrollment through the 12-week treatment period. Researchers will monitor changes in tinnitus impact and related symptoms. The study is designed to gather evidence on the effectiveness of this acoustic stimulation intervention in managing chronic tinnitus symptoms over the treatment duration.
CONDITIONS
Brief Title
Interventional Treatment of Chronic Tinnitus With Acoustic Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic tinnitus lasting over six months (with or without hearing loss)
- No organic lesions in the auditory conduction pathway or temporal bone
- Not currently receiving treatment or discontinued treatment at least three months ago
- Mentally alert and stable
- Able to communicate clearly and answer all questions from doctors and research staff
You will not qualify if you...
- Presence of organic lesions in auditory conduction pathway or temporal bone (e.g., tympanic membrane perforation, ossicular chain disruption)
- Other ear conditions such as Meniere's disease, vertigo, chronic otitis media, middle ear cholesteatoma, or 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 three months
- Inability to cooperate with medical procedures or answer questions
- Participants who dropped out or lost contact within three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive personalized acoustic stimulation using a device tailored to their tinnitus characteristics, with adjustments based on initial treatment response.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
L
Lei Cheng, PhD，MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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