Inhibitor Masking Device & SCN9 Gene Expression
To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if there is a higher incident of expression of the SCN9 gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression|
- To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device [ Time Frame: Single visit (day 1), assessed at time of visit ] [ Designated as safety issue: No ]The Inhibitor™ Tinnitus Masking Device will be demonstrated for a duration of 60 seconds and may be demonstrated up to 5 times on individuals presenting with tinnitus to evaluation any changes in tinnitus perception. Duration and degree of change will be recorded for each presentation of the device.
- Genetic Sample to look for particular genetic expression. [ Time Frame: Single visit (day 1), evaluated at the time of the genetic collection. ] [ Designated as safety issue: No ]Individuals with and without (to serve as controls) may provide a genetic sample (via blood, buccal swab or saliva) to determine presence of SCN9 gene expression. This genetic expression is associated with chronic pain. Since chronic pain and tinnitus are similar, we are trying to determine if there is a higher incident of expression of the SCN9 gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus. Those without tinnitus will serve as controls.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Individual with tinnitus.
Device: The Inhibitor™ Tinnitus Masking Device
The Inhibitor™ Tinnitus Masking Device
Other Name: The Inhibitor™ Tinnitus Masking Device
No Intervention: No tinnitus
Individuals without 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412918
|Contact: David R Friedland, MD, Ph.D.||firstname.lastname@example.org|
|Contact: Marcia L Dewey, Au.D.||email@example.com|
|Principal Investigator:||David R Friedland, MD, Ph.D.||Medical College of Wisconsin|