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

NCT ID: NCT01412918

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Tinnitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

The Inhibitor™ Tinnitus Masking Device

Intervention Type: DEVICE

The Inhibitor™ Tinnitus Masking Device

No tinnitus

Individuals without tinnitus will also be masked with the device.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Inhibitor™ Tinnitus Masking Device

The Inhibitor™ Tinnitus Masking Device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Marcia Dewey, AuD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R Friedland, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert & The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20212137 (View on PubMed)

Other Identifiers

PRO00014763

Identifier Type: -

Identifier Source: org_study_id