Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT07185061
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventional Treatment of Chronic Tinnitus With Acoustic Stimulation
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
Study Overview
Official Title:
Clinical Study on Acoustic Stimulation Intervention in Chronic Tinnitus Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: