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临床试验/NCT00730834
NCT00730834Unknown4 期

Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

Neuromonics, Inc.2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
4 期
入组人数
53
试验地点
2
主要终点
Pre and post treatment scores on Tinnitus reaction questionnaire

研究概览

简要总结

Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).

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
None

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

  • 18 years of age,
  • TRQ of at least 17 or above,
  • Able to pay for the treatment,
  • Not using any other treatment for tinnitus,
  • Access to computer and internet,
  • Compliant patient

排除标准

  • Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
  • Not willing to follow the protocol

结局指标

主要结局

Pre and post treatment scores on Tinnitus reaction questionnaire

时间窗: 6, 12, 24, 36 months

次要结局

  • Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,(6, 12, 24, 36 months)

研究者

申办方类型
Industry

研究点 (2)

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