Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07185061

Interventional Treatment of Chronic Tinnitus With Acoustic Stimulation

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-09-22

200

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The《Clinical practice guideline: tinnitus》defines tinnitus as the perception of sound without an external source, with patients lasting six months or longer classified as chronic tinnitus. Epidemiological studies indicate that tinnitus affects up to 25% of the global population. With a worldwide estimated 7.2 billion people affected, which translates to approximately 1.8 billion individuals impacted. Among these, 33% (about 590 million people) experience varying degrees of hearing impairment, and severely disrupting their work, daily life, and social interactions. Furthermore, 10%-15% of patients (approximately 180~270 million) require medical treatment or intervention. Notably, tinnitus prevalence increases with age: it affects about 29.7% of those over 60 and rises to 33% for those aged 65 and above. These statistics demonstrate that tinnitus has become one of the most significant global health challenges. In recent years, many studies have proposed an innovative therapeutic approach for tinnitus based on new research advancements in its pathogenesis. The methods termed Active Tinnitus Stimulation Therapy (ATST) and focuses on central mechanisms of tinnitus, abnormal neuronal discharges, and neural plasticity in related brain regions. The therapy tailors acoustic stimulation protocols according to individual hearing loss severity and tinnitus characteristics. Specifically, tailored acoustic signals are converted into electrical impulses in the cochlea, transmitted through auditory pathways to thalamic and auditory cortex nuclei. This process actively modulates auditory pathways, enhances filtering of chaotic signals, and activates auditory neurons. By synchronizing the self-discharge of neurons with nearby captured sound signals, ATST disrupts tinnitus generation and suppresses amplification, thereby reducing patients 'perception of tinnitus sounds. The approach comprehensively analyzes patients' hearing thresholds and tinnitus characteristics to generate personalized acoustic stimuli. Through targeted neuronal stimulation, it regulates neural plasticity, reduces abnormal discharges, and achieves active neuromodulation. Although some studies suggest that long-term periodic acoustic stimulation therapy may weaken tinnitus-related EEG networks, indicating potential improvement in chronic tinnitus, there remains a lack of large-scale clinical evidence confirming the effectiveness of this treatment for chronic tinnitus.

CONDITIONS

Official Title

Interventional Treatment of Chronic Tinnitus With Acoustic Stimulation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 have stopped treatment for over three months
  • Mentally alert and stable
  • Able to answer questions fluently from doctors and research team members
Not Eligible

You will not qualify if you...

  • Presence of organic lesions in auditory pathways 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 within the last 3 months
  • Inability to cooperate with medical procedures or answer questions
  • Participants who dropped out or lost contact within 3 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

L

Lei Cheng, PhD,MD

CONTACT

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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