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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 6, 2011 | ||||||||
| Last Updated Date | August 8, 2011 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01412918 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Inhibitor Masking Device & SCN9 Gene Expression | ||||||||
| Official Title ICMJE | Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Tinnitus | ||||||||
| Intervention ICMJE | Device: The Inhibitor™ Tinnitus Masking Device
The Inhibitor™ Tinnitus Masking Device
Other Name: The Inhibitor™ Tinnitus Masking Device |
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| Study Arms |
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| Publications * | 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, Männikkö 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. Epub 2010 Mar 8. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | December 2016 | ||||||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01412918 | ||||||||
| Other Study ID Numbers ICMJE | PRO00014763 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | David Friedland, Medical College of Wisconsin | ||||||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Medical College of Wisconsin | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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