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

Tinnitus Clinical Trial

Official title:

Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01412918
• Other study ID #: PRO00014763
• Status: Terminated
• Phase: N/A
• First received: July 6, 2011
• Last updated: January 29, 2016
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2016
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• The Inhibitor™ Tinnitus Masking Device
The Inhibitor™ Tinnitus Masking Device

Locations

Country	Name	City	State
United States	Froedtert & The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception	Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.	Single visit (day 1), assessed the day of visit	No
Secondary	Percentage of Participants Which Showed Presence of SCN9 Gene Expression.	Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.	Single visit (day 1), evaluated at the time of the genetic collection.	No