NCT00730834Unknown4 期
Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis
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
- 是
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
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2TinnitusNCT03530306Neuromod Devices Ltd.191
已完成
不适用
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)TinnitusNCT02669069Neuromod Devices Ltd.326
已完成
4 期
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")TinnitusNCT01435317ANM Adaptive Neuromodulation GmbH200
已完成
不适用
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3TinnitusNCT05227365Neuromod Devices Ltd.112
已完成
不适用
Auditory-somatosensory Stimulation to Alleviate TinnitusTinnitusNCT02974543University of Michigan35
