The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

Not Applicable

Completed

• Conditions: Vertigo; BPPV; Vestibular Disorder; Labyrinth Diseases; Benign Paroxysmal Positional Vertigo; Vestibular Diseases; Inner Ear Disease
• Interventions: Diagnostic Test: BPPV diagnostic; Device: VNG goggles; Device: TRV chair; Device: IMU sensor; Procedure: Manual BPPV diagnostics

• Registration Number: NCT05846711
• Lead Sponsor: Aalborg University Hospital

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.

Study Timeline

• Study Start: 2023-04-12
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bedside BPPV diagnostics	BPPV diagnostic	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).
Bedside BPPV diagnostics	Manual 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).
Bedside BPPV diagnostics	VNG goggles	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).
TRV BPPV diagnostics	BPPV diagnostic	Diagnostics of BPPV using the TRV chair.
TRV BPPV diagnostics	TRV chair	Diagnostics of BPPV using the TRV chair.
Bedside BPPV diagnostics	IMU sensor	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).
TRV BPPV diagnostics	VNG goggles	Diagnostics of BPPV using the TRV chair.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital; 🇩🇰 Aalborg, North Denmark Region, Denmark