Diagnostic Accuracy of Benign Paroxysmal Positional Vertigo Diagnostics With Two Different Mechanical Rotation Chairs With Two Separate Diagnostic Criteria.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Difference in the ability to diagnose BPPV
研究概览
简要总结
This study aims to investigate whether the diagnosis of benign paroxysmal positional vertigo (BPPV) is equally good with two different mechanical rotation chairs (MRCs) (TRV rotary chair and the Rotundum rotary chair). In the study, two different diagnostic criteria will be used (the international Bárány criteria and the American Academy of Otolaryngology-Head and Neck surgery (AAO-HNS) criteria) with both MRCs.
Patients with BPPV experience brief attacks of positional vertigo. Typically, this vertigo is provoked by changes in head position relative to gravity, e.g. laying down or turning to the side from the supine position.
Previous studies on the use of MRCs have shown that MRCs offer very precise and accurate BPPV diagnostics. With MRCs it is possible to determine 1) laterality (left/right), 2) specific location (specific semicircular canal), and 3) BPPV subtype (canalolithiasis/cupulolithiasis). Treatment-wise, these MRCs have also shown to be very efficient with treatment success rates being above ninety percent. The two MRCs used in this study do not offer the exact same features (e.g. design, portability, fixed positions, and the possibility of adding kinetic energy). To the knowledge of the authors, no studies exist on direct comparison of separate MRCs. The Rotundum rotary chair, which is also the newest of the two MRCs included, has so far not been included in many studies. However, the hypothesis of the current study is that the Rotundum rotary chair and the TRV rotation chair are equally good in terms of BPPV diagnostics.
详细描述
The primary aim is to investigate whether diagnostics of benign paroxysmal positional vertigo (BPPV) is equally good with two different MRCs, using both the international Bárány Society criteria and the American AAO-HNS criteria with both MRCs. Whether or not these two MRCs may be considered equally good will be evaluated based on the number of identified BPPV cases with each MRC as well as laterality (right/left), semicircular canal location (anterior/posterior/lateral) and subtype of BPPV (canalithiasis/cupulolithiasis). The participants in this study are patients with a typical BPPV history that have been referred to a University Hospital based tertiary dizziness outpatient clinic.
The following mechanical rotation chairs will be used:
- TRV® rotary chair (Interacoustics©, Middelfart, Danmark).
- Rotundum® rotary chair (balcare GmbH©, Küsnacht, Schweiz).
With MRC testing, advanced videonystagmography (VNG) glasses are used to visualize, monitor, and register eye movements. With the TRV chair, VF405® (Interacoustics©, Middelfart, Denmark) will be used with the software Micromedical VisualEyes™ (version 3.1.0.203, Interacoustics©, Middelfart, Denmark). With the Rotundum chair, the ICS Impulse® (Natus Inc©, Middleton, WA, USA) will be used with the software OTOsuite (4.88®, Natus Inc©, Middleton, WA, USA).
The same diagnostic procedure will be performed with each MRC. This includes the supine position, bilateral supine roll tests (SRTs), bilateral Dix-Hallpike tests, and, if lateral canal BPPV is ambigious, the bow and lean test. Initial MRC will be randomized.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years of age
- •Typical BPPV history
排除标准
- •Unable to comply with full diagnostic procedure in TRV and Rotundum rotary chair
- •Intake of 1st generation antihistamines within the last 7 days
- •Intake of benzodiazepines within the last 7 days
- •Known cerebral aneurysm
- •Recent cerebral hemorrhagia
- •Weight > 150 kg
结局指标
主要结局
Difference in the ability to diagnose BPPV
时间窗: 40 minutes
Statistically significant difference in the ability to induce nystagmus and/or vertigo between the TRV chair and Rotundum chair.
Agreement on the diagnosis of BPPV in individual semicircular canals and subtype of BPPV
时间窗: 40 minutes
Statistically significant difference in the ability to induce nystagmus and/or vertigo between the TRV chair and Rotundum chair for each individual semicircular canal and for subtype of BPPV i.e. canalolithiasis or cupulolithiasis.
次要结局
未报告次要终点
研究者
Dan Dupont Hougaard
Chief Physician and Associate Professor
Aalborg University Hospital