Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01412918|
Recruitment Status : Terminated (Lack of support to continue)
First Posted : August 9, 2011
Results First Posted : January 18, 2016
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: The Inhibitor™ Tinnitus Masking Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||January 2014|
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
The Inhibitor™ Tinnitus Masking Device
No Intervention: No tinnitus
Individuals without tinnitus will also be masked with the device.
- Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception [ Time Frame: Single visit (day 1), assessed the day of visit ]Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.
- Percentage of Participants Which Showed Presence of SCN9 Gene Expression. [ Time Frame: Single visit (day 1), evaluated at the time of the genetic collection. ]Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412918
|United States, Wisconsin|
|Froedtert & The Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||David R Friedland, MD, Ph.D.||Medical College of Wisconsin|