The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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). |
Diagnostic Test: BPPV diagnostic
Supine Roll Test and Dix-Hallpike Test
Device: VNG goggles
Goggles for video nystagmography
Device: IMU sensor
A sensor that measures triaxial acceleration and triaxial angular velocity.
Procedure: Manual BPPV diagnostics
Bedside BPPV diagnostics
|
| Active Comparator: TRV BPPV diagnostics Diagnostics of BPPV using the TRV chair. |
Diagnostic Test: BPPV diagnostic
Supine Roll Test and Dix-Hallpike Test
Device: TRV chair
Mechanical rotational chair
Device: VNG goggles
Goggles for video nystagmography
|
Outcome Measures
Primary Outcome Measures
- Diagnostic Accuracy [2 year]
Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.
Secondary Outcome Measures
- Head angulation during diagnostic bedside examination. [2 year]
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.
- Angular velocity during diagnostic bedside examination [2 year]
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.
Eligibility Criteria
Criteria
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:
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Pregnancy
-
Weight ≥ 150 kg and or Height ≥ 2m
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Neck and spine immobility to a degree where MD on examination bed is impossible
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Insufficient cooperation during diagnostic testing
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Sedative antihistamines taken within the past seven days
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Comorbidities: Heart failure (EF < 40), known cerebral aneurysm, cerebrovascular events (<3 months) or dissection disease
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Spontaneous or gaze evoked nystagmus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital | Aalborg | North Denmark Region | Denmark | 9000 |
Sponsors and Collaborators
- Aalborg University Hospital
Investigators
- Principal Investigator: Malene Hentze Hansen, MD, Department of Otolaryngology, Head & Neck Surgery and Audiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220061