Tinnitus
Conditions
Keywords
Tinnitus, Inhibitor Device, SCN9 gene, Ringing in the ears, Milwaukee, Medical College of Wisconsin
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.
Interventions
DEVICEThe Inhibitor™ Tinnitus Masking Device
The Inhibitor™ Tinnitus Masking Device
Sponsors
Medical College of Wisconsin
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception | Single visit (day 1), assessed the day of visit | Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Which Showed Presence of SCN9 Gene Expression. | Single visit (day 1), evaluated at the time of the genetic collection. | Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tinnitus Individual with tinnitus.
The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device | 20 |
| No Tinnitus Individuals without tinnitus. | 1 |
| Total | 21 |
Baseline characteristics
| Characteristic | Tinnitus | No Tinnitus | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 0 Participants | 20 Participants |
| Sex: Female, Male Female | 9 Participants | 0 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 1 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 1 |
| serious Total, serious adverse events | 0 / 20 | 0 / 1 |
Outcome results
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.
Time frame: Single visit (day 1), assessed the day of visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tinnitus | Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception | 76 percentage of participants |
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.
Time frame: Single visit (day 1), evaluated at the time of the genetic collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tinnitus | Percentage of Participants Which Showed Presence of SCN9 Gene Expression. | 0 % of participants with gene expression |
| No Tinnitus | Percentage of Participants Which Showed Presence of SCN9 Gene Expression. | 0 % of participants with gene expression |