DRKS00012609招募中不适用
Physiological Regulation of Chronic Tinnitus - NeuroTinn
Institute of Medical Psychology and Behavioural Neurobiology0 个研究点目标入组 60 人开始时间: 2017年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years(—)
- 性别
- All
入选标准
- •unilateral, persistent and stable tinnitus for >11 weeks,
- •normal findings using an ear microscope,
- •normal tympanic membrane mobility and stapedial reflex,
- •ability to fill out relevant questionnaires,
- •gap between the sound pressure level in the audiometric tinnitus matching (tinnitus level above
- •threshold) and the tinnitus loudness (Zenner and de Maddalena, 2005).
排除标准
- •pulsatile, intermittent, or non-persistent tinnitus,
- •bilateral tinnitus,
- •tinnitus as a concomitant symptom of a known systemic disease (such as vestibular schwannoma, endolymphatic hydrops, or Menière’s disease),
- •known retrocochlear hearing defect (such as those detected through brainstem evoked response audiometry),
- •conductive hearing loss exceeding 10 dB at two or more frequencies,
- •ear canal or middle ear inflammation or effusion,
- •one or two sided total deafness,
- •status following a craniocerebral trauma,
- •cervicogenic or stomatognatogenic tinnitus,
- •start of therapy with maskers 2 months preceding therapy,
- •start of autogenic training or psychotherapy <4 weeks before therapy,
- •ongoing acupuncture therapy,
- •drug treatment for tinnitus within 24 h preceding therapy,
- •inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine,
- •aminoglycosides) or psychotropic medication prior to entry into the study,
- •Parkinson’s disease,
- •acute allergic disease,
- •neurological or psychiatric disease,
- •drug or alcohol abuse that would interfere with regular completion of the study,
- •consuming diseases,
- •history of a severe ischemic disorder (previous stroke, previous heart attack, peripheral arterial
- •occlusion disease),
- •exposure to an investigational agent within the previous 4 weeks,
- •anticipated non-availability for study visits or procedures,
- •insufficient command of German.
研究者
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