Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients

NCT06646302 | Completed

• 1 other identifier: 2024087
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

Tinnitus; 40 Hz stimulation; Acoustic therapy; Residual inhibition; Personalized medicine

Outcome Measures

Primary Outcomes (2)

• Tinnitus suppression strength

  Residual inhibition depth, 0-100% reduction

  Immediately after the sound stimulation session.

• Residual inhibition duration

  Time in seconds until tinnitus returns to baseline after stimulation

  Immediately after the sound stimulation session.

Secondary Outcomes (2)

• EEG spectral power changes

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

• EEG functional connectivity changes

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

Study Arms (3)

Personalized 40 Hz Broadband Stimulation

EXPERIMENTAL

Participants receive personalized broadband acoustic stimulation modulated at 40 Hz. An adaptive equalization algorithm, based on individual and population residual inhibition (RI) responses, is used to weight frequency components across 125 Hz-12 kHz.

Other: Personalized 40 Hz Broadband Stimulation

40 Hz Pure Tone Stimulation

EXPERIMENTAL

Participants receive pure tone stimulation at the individually optimized carrier frequency identified in earlier phases, amplitude-modulated at 40 Hz.

Other: 40 Hz Pure Tone Stimulation

Continuous Broadband Noise

ACTIVE COMPARATOR

Participants receive continuous broadband noise stimulation without 40 Hz modulation.

Other: Continuous Broadband Noise

Interventions

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).

Personalized 40 Hz Broadband Stimulation

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.

40 Hz Pure Tone Stimulation

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.

Continuous Broadband Noise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huawei Li, PhD

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 17, 2024
• Study Start: October 28, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)