The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

Aalborg University Hospital

Status: Completed

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

Treatments: Procedure: Manual BPPV diagnostics; Device: TRV chair; Diagnostic Test: BPPV diagnostic; Device: IMU sensor; Device: VNG goggles

Study type: Interventional

Funder types: Other

Identifiers

NCT05846711

20220061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Bedside BPPV diagnostics

Active Comparator group

Description:

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).

Treatment:

Device: IMU sensor

Device: VNG goggles

Diagnostic Test: BPPV diagnostic

Procedure: Manual BPPV diagnostics

TRV BPPV diagnostics

Active Comparator group

Description:

Diagnostics of BPPV using the TRV chair.

Treatment:

Device: VNG goggles

Device: TRV chair

Diagnostic Test: BPPV diagnostic