[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605093":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":18,"id":52,"slug":18,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":18,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Use Lenire device for 1 hour daily",[13],"Device: Lenire Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Lenire Device","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.",[9],[26],{"name":27,"affiliation":5,"role":28},"Peggy Nelson","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Yezihalem Mesfin","CONTACT","763-742-6236","mesri001@umn.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Minneapolis","Minnesota","55455","United States",{"type":43,"coordinates":44},"Point",[45,46],-93.26384,44.97997,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100605093",false,"NCT07158034","Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation","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.",true,"ALL","18 Years",{"count":61,"type":62},24,"ESTIMATED","INTERVENTIONAL",[65],"NA","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.",[68],"Tinnitus","2025-10-09",{"date":71,"type":72},"2025-10-14","ACTUAL",{"date":74,"type":72},"2025-10-03",{"date":76,"type":62},"2026-06-30",{"name":5,"class":6},1]