Clinical trial NCT01412918: 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
Overall status: TERMINATED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Inhibitor Device
SCN9 gene
Ringing in the ears
Milwaukee
Medical College of Wisconsin
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception
timeFrame: Single visit (day 1), assessed the day of visit
Secondary outcomes:
measure: Percentage of Participants Which Showed Presence of SCN9 Gene Expression.
timeFrame: Single visit (day 1), evaluated at the time of the genetic collection.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert & The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: David R Friedland, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.