Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression

Study Overview
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Brief Summary
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To evaluate the effectiveness of the Inhibitor™ 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.

Detailed Description
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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 Inhibitor™ 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 Inhibitor™ 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.

Official Title
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Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression

Conditions
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Tinnitus

Intervention / Treatment
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* Device: The Inhibitor™ Tinnitus Masking Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years, has tinnitus Exclusion Criteria: Pacemaker, pregnancy, metal implants in head or neck, thrombosis, migraines/headaches, metal bonded retainer, surgeries within the last 6 months which patient is still recovering from, any medical reason your physician would advise against the use of this device, under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tinnitus<br>Individual with tinnitus. Intervention: inhibitor device demonstration. The Inhibitor™ 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 Inhibitor™ Tinnitus Masking Device. | Device: The Inhibitor™ Tinnitus Masking Device<br>* The Inhibitor™ Tinnitus Masking Device<br>|
| No Intervention: No tinnitus<br>Individuals without tinnitus will also be masked with the device. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception | Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. | Single visit (day 1), assessed the day of visit | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, Inhibitor Device, SCN9 gene, Ringing in the ears, Milwaukee, Medical College of Wisconsin