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

This study has been terminated.
(Lack of support to continue)
Sponsor:
Information provided by (Responsible Party):
Marcia Dewey, AuD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01412918
First received: July 6, 2011
Last updated: January 29, 2016
Last verified: January 2016

July 6, 2011
January 29, 2016
September 2011
September 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.
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.
Complete list of historical versions of study NCT01412918 on ClinicalTrials.gov Archive Site
Percentage of Participants Which Showed Presence of SCN9 Gene Expression. [ Time Frame: Single visit (day 1), evaluated at the time of the genetic collection. ] [ Designated as safety issue: No ]
Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.
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.
Not Provided
Not Provided
 
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (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 sodium channel, voltage gated, type IX alpha subunit (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
  • Experimental: Tinnitus

    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.

    Intervention: Device: The Inhibitor™ Tinnitus Masking Device
  • No Intervention: No tinnitus
    Individuals without tinnitus will also be masked with the device.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
January 2014
September 2013   (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   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01412918
PRO00014763
No
No
Not Provided
Marcia Dewey, AuD, 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
January 2016

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