Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over 18 years,
- •has tinnitus
排除标准
- •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
结局指标
主要结局
Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception
时间窗: 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.
次要结局
- Percentage of Participants Which Showed Presence of SCN9 Gene Expression.(Single visit (day 1), evaluated at the time of the genetic collection.)
研究者
Marcia Dewey, AuD
Associate Professor
Medical College of Wisconsin
