Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06646302
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2024-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus suppression strength', 'timeFrame': 'Immediately after the sound stimulation session.', 'description': 'Residual inhibition depth, 0-100% reduction'}, {'measure': 'Residual inhibition duration', 'timeFrame': 'Immediately after the sound stimulation session.', 'description': 'Time in seconds until tinnitus returns to baseline after stimulation'}], 'secondaryOutcomes': [{'measure': 'EEG spectral power changes', 'timeFrame': 'measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation)'}, {'measure': 'EEG functional connectivity changes', 'timeFrame': 'measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tinnitus', '40 Hz stimulation', 'Acoustic therapy', 'Residual inhibition', 'Personalized medicine'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nThis 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:\n\nPhase 1: Exploratory testing of burst versus continuous tones at different frequencies.\n\nPhase 2: Large-scale validation in 265 patients. Phase 3: Development of a personalized stimulation protocol using adaptive spectral optimization.\n\nPhase 4: EEG investigation of neural mechanisms, focusing on gamma oscillations and functional connectivity changes.\n\nThe 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.\n\nBy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with subjective tinnitus;\n2. Chronic tinnitus: tinnitus course ≥ 1 month;\n3. Normal middle ear function;\n4. The average hearing threshold (defined as mean of 0.5, 1, 2, and 4 kHz) of the unaffected ear \\< 60 dB;\n5. Tinnitus can be heard under normal circumstances.\n6. 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.\n\nExclusion Criteria:\n\n1. Acute phase tinnitus;\n2. Fluctuating tinnitus loudness;\n3. Severe psychiatric disorders;\n4. Inability to complete tinnitus testing;\n5. Fluctuating or retrocochlear hearing loss;\n6. Conductive hearing loss;\n7. Currently participating in other research projects that may affect tinnitus;\n8. Subjects who are not considered suitable for this clinical trial by the researchers.'}, 'identificationModule': {'nctId': 'NCT06646302', 'briefTitle': 'Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Neural and Clinical Effects of 40 Hz Burst Stimulation in Tinnitus: a Four-phase Self-controlled Study', 'orgStudyIdInfo': {'id': '2024087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized 40 Hz Broadband Stimulation', 'description': '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.', 'interventionNames': ['Other: Personalized 40 Hz Broadband Stimulation']}, {'type': 'EXPERIMENTAL', 'label': '40 Hz Pure Tone Stimulation', 'description': 'Participants receive pure tone stimulation at the individually optimized carrier frequency identified in earlier phases, amplitude-modulated at 40 Hz.', 'interventionNames': ['Other: 40 Hz Pure Tone Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Broadband Noise', 'description': 'Participants receive continuous broadband noise stimulation without 40 Hz modulation.', 'interventionNames': ['Other: Continuous Broadband Noise']}], 'interventions': [{'name': 'Personalized 40 Hz Broadband Stimulation', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Personalized 40 Hz Broadband Stimulation']}, {'name': '40 Hz Pure Tone Stimulation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['40 Hz Pure Tone Stimulation']}, {'name': 'Continuous Broadband Noise', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Continuous Broadband Noise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Eye & ENT Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Huawei Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}