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

Primary Purpose

Tinnitus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Inhibitor™ Tinnitus Masking Device
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Inhibitor Device, SCN9 gene, Ringing in the ears, Milwaukee, Medical College of Wisconsin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Froedtert & The Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tinnitus

No tinnitus

Arm Description

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.

Individuals without tinnitus will also be masked with the device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 6, 2011
Last Updated
January 29, 2016
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01412918
Brief Title
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression
Official Title
Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of support to continue
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Inhibitor Device, SCN9 gene, Ringing in the ears, Milwaukee, Medical College of Wisconsin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tinnitus
Arm Type
Experimental
Arm Description
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.
Arm Title
No tinnitus
Arm Type
No Intervention
Arm Description
Individuals without tinnitus will also be masked with the device.
Intervention Type
Device
Intervention Name(s)
The Inhibitor™ Tinnitus Masking Device
Intervention Description
The Inhibitor™ Tinnitus Masking Device
Primary Outcome Measure Information:
Title
Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception
Description
Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.
Time Frame
Single visit (day 1), assessed the day of visit
Secondary Outcome Measure Information:
Title
Percentage of Participants Which Showed Presence of SCN9 Gene Expression.
Description
Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.
Time Frame
Single visit (day 1), evaluated at the time of the genetic collection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Friedland, MD, Ph.D.
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert & The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20212137
Citation
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, Mannikko 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.
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Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression

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