The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Benign Paroxysmal Positional Vertigo, BPPV, Vertigo, Vestibular Disorder, Vestibular Diseases, Labyrinth Diseases, Inner Ear Disease

Intervention / Treatment
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* Diagnostic Test: BPPV diagnostic
* Device: TRV chair
* Device: VNG goggles
* Device: IMU sensor
* Procedure: Manual BPPV diagnostics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bedside BPPV diagnostics<br>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). | Diagnostic Test: BPPV diagnostic<br>* Supine Roll Test and Dix-Hallpike Test<br>Device: VNG goggles<br>* Goggles for video nystagmography<br>Device: IMU sensor<br>* A sensor that measures triaxial acceleration and triaxial angular velocity.<br>Procedure: Manual BPPV diagnostics<br>* Bedside BPPV diagnostics<br>|
| Active Comparator: TRV BPPV diagnostics<br>Diagnostics of BPPV using the TRV chair. | Diagnostic Test: BPPV diagnostic<br>* Supine Roll Test and Dix-Hallpike Test<br>Device: TRV chair<br>* Mechanical rotational chair<br>Device: VNG goggles<br>* Goggles for video nystagmography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy | Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head angulation during diagnostic bedside examination. | Angulation of the head during diagnostic bedside examination will be measured using an IMU sensor. Data will be presented as the difference in head angulation compared to the ideal angulation descriped for the diagnostic tests. | 2 year | 
| Angular velocity during diagnostic bedside examination | Angular velocity of the head movements during diagnostic bedside examination will be measured using an IMU sensor. Data will be presented as mean velocity and peak velocity. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TRV reposition chair, Dix-Hallpike maneuver, Supine Roll Test