The Diagnostic Accuracy of Ankle Audiometry Performed With the B250 for Superior Canal Dehiscence Syndrome in Patients Affected by Pulsatile Tinnitus and/or Autophony Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The detection of SCDS among patients with autophony and/or pulsatile tinnitus.
研究概览
简要总结
The goal of this clinical trial is to learn if the ankle audiometry test performed with the B250 bone conduction transducer can identify patients with superior canal dehiscence syndrome from those without among subjects presenting with autophony (a hearing condition where you hear your own body sounds) and/or pulsatile tinnitus.
The main question it aims to answer:
• Can ankle audiometry performed with B250 identify the condition of superior canal dehiscence syndrome among patients with autophony and/or pulsatile tinnitus, with a significance level of 80% and power level of 15%?
Study participants will undergo ankle audiometry testing with the B250 and the threshold in dB FL (at the ankle) for which the patient hears the sound in the target ear will be measured.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 64 years.
- •Patients with symptoms of autophony and/or pulsatile tinnitus either due to a confirmed diagnosis of SCDS or not due to SCDS.
排除标准
- •Severe sensorineural hearing.
- •Middle ear or ear canal pathologies.
- •Vulnerable patients.
- •Confirmed intolerance or contraindication for body (ankle) vibratory stimulation.
- •Anatomical body anomalies affecting normal testing procedure or interpretation of results.
研究组 & 干预措施
Ankle audiometry testing with B250
The arm consist of 30 consecutive adults (18-64 years) with autophony and/or pulsatile tinnitus, of which at least 15 are affected by superior canal dehiscense syndrome. All subjects will undergo testing with ankle audiometry (intervention) according to the method described in PMID: 36634643
干预措施: Ankle audiometry performed with the B250 transducer (Diagnostic Test)
结局指标
主要结局
The detection of SCDS among patients with autophony and/or pulsatile tinnitus.
时间窗: At the end of the performed ankle audiometry test.
次要结局
未报告次要终点
研究者
Luca Verrecchia
Principal investigator
Region Stockholm