The Accuracy of Manual BPPV Diagnostics: A Randomized Crossover Study With Comparison of Manual Diagnostic and Diagnostic in TRV Chair, When Using VNG Goggles in Both Scenarios.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
The aim is to investigate the accuracy of manual diagnostics of benign paroxysmal positional vertigo (BPPV) by comparing it to BPPV diagnostics in mechanical rotational chair (TRV chair). VNG (videonystagmography) goggles will be used in both scenarios.
Furthermore, the investigators will examine the importance of angulation and velocity in relation to the diagnostic outcome.
详细描述
Open-label, randomized controlled trial with cross over comparing manual bedside BPPV diagnostics with diagnostics in a mechanical rotational chair (TRV chair) when using VNG goggles in both scenarios.
Patients with a history of positional vertigo will be considered for enrollment and randomized to which diagnostic modality they begin with. Each subject will wait for minimum 30 minutes between the two diagnostics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age above 18 years
- •Classic BPPV-patient history (short lasting (<1 minute) positional rotatory vertigo, no accompanying tinnitus or hearing loss, and no focal neurological findings.
- •Understand written and spoken Danish
排除标准
- •Pregnancy
- •Weight ≥ 150 kg and or Height ≥ 2m
- •Neck and spine immobility to a degree where MD on examination bed is impossible
- •Insufficient cooperation during diagnostic testing
- •Sedative antihistamines taken within the past seven days
- •Comorbidities: Heart failure (EF < 40), known cerebral aneurysm, cerebrovascular events (<3 months) or dissection disease
- •Spontaneous or gaze evoked nystagmus
研究组 & 干预措施
Bedside BPPV diagnostics
Diagnostics of BPPV with manual tests using VNG goggles. The goggles will be added an IMU sensor detecting angulation and velocity (the physician will not get feedback from the sensor during the examination. This will only be used in later analysis).
干预措施: BPPV diagnostic (Diagnostic Test)
Bedside BPPV diagnostics
Diagnostics of BPPV with manual tests using VNG goggles. The goggles will be added an IMU sensor detecting angulation and velocity (the physician will not get feedback from the sensor during the examination. This will only be used in later analysis).
干预措施: VNG goggles (Device)
Bedside BPPV diagnostics
Diagnostics of BPPV with manual tests using VNG goggles. The goggles will be added an IMU sensor detecting angulation and velocity (the physician will not get feedback from the sensor during the examination. This will only be used in later analysis).
干预措施: IMU sensor (Device)
Bedside BPPV diagnostics
Diagnostics of BPPV with manual tests using VNG goggles. The goggles will be added an IMU sensor detecting angulation and velocity (the physician will not get feedback from the sensor during the examination. This will only be used in later analysis).
干预措施: Manual BPPV diagnostics (Procedure)
TRV BPPV diagnostics
Diagnostics of BPPV using the TRV chair.
干预措施: BPPV diagnostic (Diagnostic Test)
TRV BPPV diagnostics
Diagnostics of BPPV using the TRV chair.
干预措施: TRV chair (Device)
TRV BPPV diagnostics
Diagnostics of BPPV using the TRV chair.
干预措施: VNG goggles (Device)
结局指标
主要结局
Diagnostic Accuracy
时间窗: 2 year
Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.
次要结局
- Head angulation during diagnostic bedside examination.(2 year)
- Angular velocity during diagnostic bedside examination(2 year)
研究者
Malene Hentze Hansen
Principal Investigator
Aalborg University Hospital