Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT07158034
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in brain waves at 6 weeks', 'timeFrame': 'Week 6', 'description': 'Assessed via 32-channel EEG recording'}], 'secondaryOutcomes': [{'measure': 'Correlation between change in EBDBE, ABR, THI, and PSS-10', 'timeFrame': 'Week 6', 'description': 'Assessed via Tinnitus Handicap Inventory (THI) and Perceived Stress Scale (PSS), for which lower scores indicate a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Treatment Group Inclusion Criteria:\n\n* 18 years and over at time of consent\n* Ability to read and understand English\n* Willing and able to provide and understand informed consent\n* Willing to commit to the full duration of the investigation\n* Subjective tinnitus\n* Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group)\n* Baseline THI score from 40 to 76 (only for participants in treatment group)\n* Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)\n\nTreatment Group Exclusion Criteria:\n\n* Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group)\n* Objective tinnitus\n* Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting\n* Began wearing hearing aids within the past 3 months\n* A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss.\n* History of auditory hallucinations\n* Tumor on the hearing or balance nervous systems\n* Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months\n* Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.\n* Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.\n* Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.\n* Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)\n* Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)\n* Participant with a pacemaker or other electro-active implanted device\n* Participant previously diagnosed with psychosis or schizophrenia\n* Participants diagnosed with Burning Mouth Syndrome\n* A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered\n* Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus\n* Inability to physically or comprehensively use the device\n* Oral piercings that cannot or will not be removed\n* Pregnancy per patient report\n* Prisoner\n* PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.\n\nControl Group Inclusion Criteria:\n\n* 18 years and over at time of consent\n* Ability to read and understand English\n* Willing and able to provide and understand informed consent\n* Willing to commit to the full duration of the investigation\n\nControl Group Exclusion Criteria:\n\n* Began wearing hearing aids within the past 3 months\n* Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months\n* Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.\n* Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.\n* Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.\n* Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)\n* Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)\n* Participant previously diagnosed with psychosis or schizophrenia\n* A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered\n* Prisoner\n* PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided."}, 'identificationModule': {'nctId': 'NCT07158034', 'briefTitle': 'Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation', 'orgStudyIdInfo': {'id': 'STUDY00025649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Use Lenire device for 1 hour daily', 'interventionNames': ['Device: Lenire Device']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.'}], 'interventions': [{'name': 'Lenire Device', 'type': 'DEVICE', 'description': 'The Lenire device is a non-invasive stimulation system designed to reduce the symptoms of chronic subjective tinnitus. It includes a controller that is connected to headphones for sound delivery to the ears and a mouthpiece that provides mild electrical stimulation to the surface of the tongue. Users are recommended to use the device for 60 minutes daily, either in two consecutive 30-minute sessions or at different times throughout the day, for a minimum of 36 hours.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yezihalem Mesfin', 'role': 'CONTACT', 'email': 'mesri001@umn.edu', 'phone': '763-742-6236'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Yezihalem Mesfin', 'role': 'CONTACT', 'email': 'mesri001@umn.edu', 'phone': '763-742-6236'}], 'overallOfficials': [{'name': 'Peggy Nelson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}