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Lack of support to continue
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To evaluate the effectiveness of the Inhibitorâ„¢ Tinnitus Masking Device. To determine if there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.
Up to 50 million Americans have tinnitus on a regular basis with between 2-3 million suffering from tinnitus where it affects daily living. The Inhibitorâ„¢ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitorâ„¢ Tinnitus Masking Device. Patients may provide a genetic sample (typically via saliva sample) to look for expression of a particular genetic marker that may be associated with tinnitus. The investigators will be collect samples from both people with tinnitus and those without tinnitus to use as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tinnitus | Experimental | Individual with tinnitus. Intervention: inhibitor device demonstration. The Inhibitorâ„¢ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitorâ„¢ Tinnitus Masking Device. |
|
| No tinnitus | No Intervention | Individuals without tinnitus will also be masked with the device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Inhibitorâ„¢ Tinnitus Masking Device | Device | The Inhibitorâ„¢ Tinnitus Masking Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Percentage of Participants for Which the Inhibitorâ„¢ Tinnitus Masking Device Effected Tinnitus Perception | Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitorâ„¢ Tinnitus Masking Device. | Single visit (day 1), assessed the day of visit |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Which Showed Presence of SCN9 Gene Expression. | Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression. | Single visit (day 1), evaluated at the time of the genetic collection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Friedland, MD, Ph.D. | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert & The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20212137 | Background | Reimann F, Cox JJ, Belfer I, Diatchenko L, Zaykin DV, McHale DP, Drenth JP, Dai F, Wheeler J, Sanders F, Wood L, Wu TX, Karppinen J, Nikolajsen L, Mannikko M, Max MB, Kiselycznyk C, Poddar M, Te Morsche RH, Smith S, Gibson D, Kelempisioti A, Maixner W, Gribble FM, Woods CG. Pain perception is altered by a nucleotide polymorphism in SCN9A. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5148-53. doi: 10.1073/pnas.0913181107. Epub 2010 Mar 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tinnitus | Individual with tinnitus. The Inhibitorâ„¢ Tinnitus Masking Device: The Inhibitorâ„¢ Tinnitus Masking Device |
| FG001 | No Tinnitus | Individuals without tinnitus. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline participants with tinnitus demonstrating the Inhibitorâ„¢ Tinnitus Masking Device.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tinnitus | Individual with tinnitus. The Inhibitorâ„¢ Tinnitus Masking Device: The Inhibitorâ„¢ Tinnitus Masking Device |
| BG001 | No Tinnitus | Individuals without tinnitus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Determine the Percentage of Participants for Which the Inhibitorâ„¢ Tinnitus Masking Device Effected Tinnitus Perception | Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitorâ„¢ Tinnitus Masking Device. | Posted | Number | percentage of participants | Single visit (day 1), assessed the day of visit |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tinnitus | Individual with tinnitus. Intervention: inhibitor device demonstration. The Inhibitorâ„¢ Tinnitus Masking Device: The Inhibitorâ„¢ Tinnitus Masking Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Friedland | Medical College of Wisconsion | 414-805- | dfriedland@mcw.edu |
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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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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Percentage of Participants Which Showed Presence of SCN9 Gene Expression. | Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression. | Posted | Number | % of participants with gene expression | Single visit (day 1), evaluated at the time of the genetic collection. |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | No Tinnitus | Individuals without tinnitus. | 0 | 1 | 0 | 1 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |