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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Use Lenire device for 1 hour daily |
|
| Control Group | No Intervention | Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenire Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain waves at 6 weeks | Assessed via 32-channel EEG recording | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between change in EBDBE, ABR, THI, and PSS-10 | Assessed via Tinnitus Handicap Inventory (THI) and Perceived Stress Scale (PSS), for which lower scores indicate a better outcome. | Week 6 |
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Treatment Group Inclusion Criteria:
Treatment Group Exclusion Criteria:
Control Group Inclusion Criteria:
Control Group Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yezihalem Mesfin | Contact | 763-742-6236 | mesri001@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peggy Nelson | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |