Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients

Last updated: September 5, 2025
Sponsor: Eye & ENT Hospital of Fudan University
Overall Status: Completed

Phase

N/A

Condition

Tinnitus

Treatment

Continuous Broadband Noise

Tinnitus frequency-centered narrowband noise stimulation

Personalized 40 Hz Broadband Stimulation

Clinical Study ID

NCT06646302
2024087
  • Ages 18-70
  • All Genders

Study Summary

Tinnitus affects 10-15% of adults and is frequently associated with impaired quality of life, anxiety, and sleep disturbance. Conventional sound therapies based on continuous masking provide inconsistent and short-lived relief, and the neural mechanisms underlying residual inhibition (RI) remain unclear.

This study aims to determine whether 40 Hz burst stimulation with high-frequency carriers can achieve longer-lasting RI than continuous sound, and to explore its underlying neural mechanisms using EEG.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with subjective tinnitus;

  2. Chronic tinnitus: tinnitus course ≥ 1 month;

  3. Normal middle ear function;

  4. The average hearing threshold (defined as mean of 0.5, 1, 2, and 4 kHz) of theunaffected ear < 60 dB;

  5. Tinnitus can be heard under normal circumstances.

  6. Subjects are able to understand the purpose of the study, volunteer to participateand cooperate with the instructors to complete the experiment, and be willing tosign the informed consent.

Exclusion

Exclusion Criteria:

  1. Acute phase tinnitus;

  2. Fluctuating tinnitus loudness;

  3. Severe psychiatric disorders;

  4. Inability to complete tinnitus testing;

  5. Fluctuating or retrocochlear hearing loss;

  6. Conductive hearing loss;

  7. Currently participating in other research projects that may affect tinnitus;

  8. Subjects who are not considered suitable for this clinical trial by the researchers.

Study Design

Total Participants: 265
Treatment Group(s): 5
Primary Treatment: Continuous Broadband Noise
Phase:
Study Start date:
October 28, 2024
Estimated Completion Date:
July 18, 2025

Study Description

Residual inhibition (RI) refers to the temporary reduction or disappearance of tinnitus following sound stimulation and provides an important clue for identifying patients who may benefit from acoustic therapy. However, the effects of different sound stimulation strategies on RI remain poorly understood.

This study evaluates whether 40 Hz burst-modulated sound achieves stronger and longer RI compared with conventional continuous stimulation. The trial follows a four-phase design:

Phase 1: Exploratory testing of burst versus continuous tones at different frequencies.

Phase 2: Large-scale validation in 265 patients. Phase 3: Development of a personalized stimulation protocol using adaptive spectral optimization.

Phase 4: EEG investigation of neural mechanisms, focusing on gamma oscillations and functional connectivity changes.

The primary outcomes are the strength and duration of tinnitus suppression. Secondary outcomes include EEG markers such as γ-band power spectral density and phase-locking value.

By combining behavioral and neurophysiological measures, this study aims to establish 40 Hz burst stimulation as a novel rhythm-based sound therapy and to provide mechanistic insights that may enable more effective, personalized tinnitus management.

Connect with a study center

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai 200031
    China

    Site Not Available

  • Eye & ENT Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200031
    China

    Site Not Available

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