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RecruitingNCT07185061Updated Sep 22, 2025

Interventional Treatment of Chronic Tinnitus With Acoustic Stimulation

An interventional study of Acoustic Stimulation in Chronic Tinnitus, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2024, registered Sep 2025).
  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Tinnitus
03

In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Chronic tinnitus

    Device: Acoustic Stimulation

Interventions

  • DeviceAcoustic Stimulation

    Using hearing loss detection and tinnitus matching data as input parameters, the system automatically generates personalized sound stimulation audio signals through composite signal amplitude, frequency, phase control processing, and notch filtering. The audio tone is fine-tuned based on the patient's initial treatment response to identify their most comfortable range.

06

What researchers measure

Primary outcomes

  1. Scores of Tinnitus Handicap Inventory

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  1. Scores of Self-rating Anxiety Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Scores of Pittsburgh sleep quality index

    Time frame: From enrollment to the end of treatment at 12 weeks

  3. Scores of Self-ratingDepression Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 210029, China
    • The First Affiliated Hospital with Nanjing Medical University · Contact · jsphkj@163.com · 025 68636360
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07185061
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Sep 22, 2025
Start date
Oct 1, 2024
Primary completion
Jul 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 22, 2025

Study contacts

Lei Cheng, PhD,MD
Contact
chenglei@jsph.org.cn
+86 13776620807

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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