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The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. In particular, the sound stimulus will not contain the pitch of the tinnitus, which may increase comfort and usability with the device since it will be customized to their tinnitus. Furthermore, virtual follow-up assessments and/or phone calls will be performed, thus significantly reducing the burden and personnel requirements for in-person visits as originally performed with the current clinic process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized Bimodal Stimulation | Experimental | The study consists of one device per participant and is completed at home by the participant. Participants will be asked that bimodal stimulation is completed for one hour per day, in two 30-minute sessions every day, for the 12-week period. Eligible participants who consent to the study will be trained to use the device at ENROLLMENT. The 12-weeks of stimulation will consist of synchronized bimodal stimulation in which the participants' dominant tinnitus frequency will be removed from the stimulation setting via a programmed notched filter setting. A FINAL visit will be scheduled approximately 12-weeks from ENROLLMENT. Participants will be required to return their device at this visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimodal Neuromodulation | Device | The device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. The sound is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during device fitting. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rate after 12 weeks of bimodal stimulation | Measure compliance rate in terms of the amount of time using the bimodal stimulation device over a 12 week period and demonstrate a similar rate to previous published results. | From enrollment visit to end of bimodal stimulation at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction rate after 12 weeks of bimodal stimulation | Measure satisfaction rate in terms of two satisfaction questions after 12 weeks of bimodal stimulation and to demonstrate a similar rate to previous published results. | From enrollment visit to end of bimodal stimulation at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the stimulation device on tinnitus symptoms after 12 weeks of bimodal stimulation | Tinnitus Handicap Inventory (THI). The THI total scores ranges from 0 to 100, with higher scores reflecting greater severity of tinnitus handicap. | From enrollment visit to end of bimodal stimulation at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Feng | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota - PWB | 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 |