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临床试验/NCT01412918
NCT01412918终止不适用

Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcia Dewey, AuD

Associate Professor

Medical College of Wisconsin

研究点 (2)

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