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The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05846711
Enrollment
215
Registered
2023-05-06
Start date
2023-04-12
Completion date
2024-01-11
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

TRV reposition chair, Dix-Hallpike maneuver, Supine Roll Test

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.

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.

Interventions

DIAGNOSTIC_TESTBPPV diagnostic

Supine Roll Test and Dix-Hallpike Test

DEVICETRV chair

Mechanical rotational chair

DEVICEVNG goggles

Goggles for video nystagmography

DEVICEIMU sensor

A sensor that measures triaxial acceleration and triaxial angular velocity.

PROCEDUREManual BPPV diagnostics

Bedside BPPV diagnostics

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy2 yearSensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.

Secondary

MeasureTime frameDescription
Head angulation during diagnostic bedside examination.2 yearAngulation 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 examination2 yearAngular 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026