TinnitusNCT06646302
Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients
A study testing Personalized 40 Hz Broadband Stimulation, 40 Hz Pure Tone Stimulation and Continuous Broadband Noise in people with Tinnitus, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Personalized 40 Hz Broadband Stimulation, 40 Hz Pure Tone Stimulation and Continuous Broadband Noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2024to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Reversible Suppression of a Phantom Percept is Associated With State-dependent Cortical Network Reconfiguration
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.
Read the detailed 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: An independent EEG cohort undergoing a randomized crossover comparison of personalized burst and continuous broadband stimulation to investigate changes in gamma-band functional connectivity associated with residual inhibition.
The primary outcomes are the strength and duration of tinnitus suppression. Secondary outcomes include EEG-derived measures of source-space functional connectivity, quantified using phase-locking value (PLV) in the gamma band (38-42 Hz).
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.
- Conditions
- Tinnitus
- Being tested
- Personalized 40 Hz Broadband Stimulation, 40 Hz Pure Tone Stimulation, Continuous Broadband Noise
- Keywords
- Tinnitus, 40 Hz stimulation, Acoustic therapy, Residual inhibition, Personalized medicine
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized 40 Hz Broadband StimulationOther
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 StimulationOther
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 NoiseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 40 Hz Pure Tone Stimulation |
| Continuous Broadband Noise | Active comparator | Participants receive continuous broadband noise stimulation without 40 Hz modulation. Receives: Other: Continuous Broadband Noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus suppression strength
Residual inhibition depth, 0-100% reduction
Measured: Immediately after the sound stimulation session.
Residual inhibition duration
Time in seconds until tinnitus returns to baseline after stimulation
Measured: Immediately after the sound stimulation session.
Secondary outcomes (1)
EEG functional connectivity changes
Changes in source-space functional connectivity quantified using phase-locking value (PLV) in the gamma band (38-42 Hz), comparing stimulation and post-stimulation periods with baseline.
Measured: measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start28 Oct 2024
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huawei Li, PhD, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646302
- Sponsor's protocol ID
- 2024087
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversible Suppression of a Phantom Percept is Associated With State-dependent Cortical Network Reconfiguration
- ClinicalTrials.gov ID
- NCT06646302
- Acronym / sponsor ID
- 2024087
- Conditions
- Tinnitus
- Keywords
- Tinnitus, 40 Hz stimulation, Acoustic therapy, Residual inhibition, Personalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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: An independent EEG cohort undergoing a randomized crossover comparison of personalized burst and continuous broadband stimulation to investigate changes in gamma-band functional connectivity associated with residual inhibition.
The primary outcomes are the strength and duration of tinnitus suppression. Secondary outcomes include EEG-derived measures of source-space functional connectivity, quantified using phase-locking value (PLV) in the gamma band (38-42 Hz).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized 40 Hz Broadband Stimulation | Experimental | Other: Personalized 40 Hz Broadband StimulationParticipants 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. |
| 40 Hz Pure Tone Stimulation | Experimental | Other: 40 Hz Pure Tone StimulationParticipants receive pure tone stimulation at the individually optimized carrier frequency identified in earlier phases, amplitude-modulated at 40 Hz. |
| Continuous Broadband Noise | Active comparator | Other: Continuous Broadband NoiseParticipants receive continuous broadband noise stimulation without 40 Hz modulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Acute phase tinnitus;
- Fluctuating tinnitus loudness;
- Severe psychiatric disorders;
- Inability to complete tinnitus testing;
- Fluctuating or retrocochlear hearing loss;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized 40 Hz Broadband StimulationBroadband 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). | Other | Personalized 40 Hz Broadband Stimulation |
| 40 Hz Pure Tone StimulationPure 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. | Other | 40 Hz Pure Tone Stimulation |
| Continuous Broadband NoiseContinuous 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. | Other | Continuous Broadband Noise |
Primary outcome
Tinnitus suppression strength
Time frame: Immediately after the sound stimulation session.
Residual inhibition depth, 0-100% reduction
Residual inhibition duration
Time frame: Immediately after the sound stimulation session.
Time in seconds until tinnitus returns to baseline after stimulation
1 secondary outcome
EEG functional connectivity changes
Time frame: measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huawei Li, PhD principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized 40 Hz Broadband Stimulation, 40 Hz Pure Tone Stimulation and Continuous Broadband Noise in people with Tinnitus, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus suppression strength (time frame: Immediately after the sound stimulation session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.