Inhibitor Masking Device & SCN9 Gene Expression

This study is not yet open for participant recruitment.
Verified May 2011 by Medical College of Wisconsin
Sponsor:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01412918
First received: July 6, 2011
Last updated: August 8, 2011
Last verified: May 2011

July 6, 2011
August 8, 2011
September 2011
September 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01412918 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Inhibitor Masking Device & SCN9 Gene Expression
Clinical Evaluation of the Inhibitor Tinnitus Treatment 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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tinnitus
Device: The Inhibitor™ Tinnitus Masking Device
The Inhibitor™ Tinnitus Masking Device
Other Name: The Inhibitor™ Tinnitus Masking Device
  • Experimental: Tinnitus
    Individual with tinnitus.
    Intervention: Device: The Inhibitor™ Tinnitus Masking Device
  • No Intervention: No tinnitus
    Individuals without tinnitus.
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. doi: 10.1073/pnas.0913181107. Epub 2010 Mar 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
December 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: David R Friedland, MD, Ph.D. 414-805-5625 dfriedland@mcw.edu
Contact: Marcia L Dewey, Au.D. 4148-5-5680 mdewey@mcw.edu
Not Provided
 
NCT01412918
PRO00014763
No
David Friedland, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: David R Friedland, MD, Ph.D. Medical College of Wisconsin
Medical College of Wisconsin
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP