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Completed

NCT Number: NCT06646302

Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with subjective tinnitus;
  • Chronic tinnitus: tinnitus course ≥ 1 month;
  • Normal middle ear function;
  • The average hearing threshold (defined as mean of 0.5, 1, 2, and 4 kHz) of the unaffected ear < 60 dB;
  • Tinnitus can be heard under normal circumstances.
  • Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.

Exclusion criteria

  • Acute phase tinnitus;
  • Fluctuating tinnitus loudness;
  • Severe psychiatric disorders;
  • Inability to complete tinnitus testing;
  • Fluctuating or retrocochlear hearing loss;
  • Conductive hearing loss;
  • Currently participating in other research projects that may affect tinnitus;
  • Subjects who are not considered suitable for this clinical trial by the researchers.

Treatment and study plan

Personalized 40 Hz Broadband Stimulation

Other

Broadband acoustic stimulus (125 Hz-12 kHz) amplitude-modulated at 40 Hz with a 50% duty cycle. A polynomial regression and FFT-based algorithm applies individualized frequency weighting, combining population data (70%) and patient-specific responses (30%). Delivered for 60 seconds at 10 dB above the individual minimum masking level (MML).

40 Hz Pure Tone Stimulation

Other

Pure tone stimulus at the optimized frequency (matched to tinnitus characteristics or high-frequency carrier), amplitude-modulated at 40 Hz with a 50% duty cycle. Delivered for 60 seconds at 10 dB above MML.

Continuous Broadband Noise

Other

Continuous broadband noise spanning 125 Hz-12 kHz without 40 Hz modulation. Delivered for 60 seconds at 10 dB above MML as an active control condition.

Primary outcomes

  1. Tinnitus suppression strength

    Time frame: Immediately after the sound stimulation session.

    Residual inhibition depth, 0-100% reduction

  2. Residual inhibition duration

    Time frame: Immediately after the sound stimulation session.

    Time in seconds until tinnitus returns to baseline after stimulation

Secondary outcomes

  1. EEG spectral power changes

    Time frame: measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation)

  2. EEG functional connectivity changes

    Time frame: measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation)

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Neural and Clinical Effects of 40 Hz Burst Stimulation in Tinnitus: a Four-phase Self-controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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