Interest of Electro-physiological Findings in the Assessment of Symptoms Severity in Superior Semi-circular Canal Dehiscence Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- EcoG validity - pulsatile tinnitus
研究概览
简要总结
This research aims at assessing the validity of three different electro-physiological tests (Vestibular Evoked Myogenic Potentials, WideBand Tympanometry, Electrocochleography) used in the investigation of the symptoms severity in the case of superior semi-circular canal dehiscence syndrome.
详细描述
Superior semi-circular canal dehiscence (SCD) syndrome can associate several cochlear and vestibular symptoms. Recent systematic reviews identified pulsatile tinnitus, autophony, sound-induced and pressure-induced vertigo as most specific signs of SCD. These signs are rarely all present and the symptomatology remains highly variable from a patient to another, with frequent though less evocative symptoms such as dizziness or ear pressure. A surgical treatment may be proposed when the symptoms become significantly incapacitating. Unfortunately to date, there is no objective marker of this severity and all surgical decisions rely on the importance of patients' complaints. High Resolution Computed Tomography (HRCT) of the temporal bone can confirm the diagnosis. Electro-physiological investigations such as Vestibular Evoked Myogenic potentials (VEMPs) have also been extensively described in the diagnosis of SCD but they have been reported as independent from the symptoms severity. Wideband tympanometry (WBT) and Electrocochleography (EcoG) have only been studied in few reports but the latter appears as a promising tool in the assessment of the symptoms because it explores inner ear biomechanics, directly involved in the pathophysiology of this condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •confirmed unilateral SCD (using specific HRCT settings and reconstructions) with or without SCD symptoms
- •if present, SCD symptoms should be stable
- •patients understanding and reading french
- •affiliated to social security.
排除标准
- •bilateral confirmed SCD
- •doubtful SCD
- •other otologic or neurotologic condition that might mimick SCD symptomatology : middle ear conditions, Meniere disease, vestibular migraine
结局指标
主要结局
EcoG validity - pulsatile tinnitus
时间窗: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (pulsatile tinnitus) assessed by a visual analogue scale (0 to 10)
EcoG validity - autophony
时间窗: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (autophony) assessed by a visual analogue scale (0 to 10)
EcoG validity - dizziness induced by loud sounds
时间窗: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (dizziness induced by loud sounds) assessed by a visual analogue scale (0 to 10)
EcoG validity - dizziness induced by pressure changes
时间窗: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (dizziness induced by pressure changes) assessed by a visual analogue scale (0 to 10)
次要结局
未报告次要终点
