The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

NCT ID: NCT05846711

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2024-01-11

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

BPPV diagnostic

Intervention Type DIAGNOSTIC_TEST

Supine Roll Test and Dix-Hallpike Test

VNG goggles

Intervention Type DEVICE

Goggles for video nystagmography

IMU sensor

Intervention Type DEVICE

A sensor that measures triaxial acceleration and triaxial angular velocity.

Manual BPPV diagnostics

Intervention Type PROCEDURE

Bedside BPPV diagnostics

TRV BPPV diagnostics

Diagnostics of BPPV using the TRV chair.

Group Type ACTIVE_COMPARATOR

BPPV diagnostic

Intervention Type DIAGNOSTIC_TEST

Supine Roll Test and Dix-Hallpike Test

TRV chair

Intervention Type DEVICE

Mechanical rotational chair

VNG goggles

Intervention Type DEVICE

Goggles for video nystagmography

Interventions

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BPPV diagnostic

Supine Roll Test and Dix-Hallpike Test

Intervention Type DIAGNOSTIC_TEST

TRV chair

Mechanical rotational chair

Intervention Type DEVICE

VNG goggles

Goggles for video nystagmography

Intervention Type DEVICE

IMU sensor

A sensor that measures triaxial acceleration and triaxial angular velocity.

Intervention Type DEVICE

Manual BPPV diagnostics

Bedside BPPV diagnostics

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Malene Hentze Hansen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malene Hentze Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Head & Neck Surgery and Audiology

Locations

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Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

References

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Hentze M, Hougaard DD, Kingma H. Impact of head orientation and head movement in traditional manual diagnostics of benign paroxysmal positional vertigo: a randomized controlled crossover study. Front Neurol. 2025 Oct 3;16:1654404. doi: 10.3389/fneur.2025.1654404. eCollection 2025.

Reference Type DERIVED
PMID: 41111959 (View on PubMed)

Hentze M, Hougaard DD, Kingma H. The Intra-Examiner Variability in and Accuracy of Traditional Manual Diagnostics of Benign Paroxysmal Positional Vertigo: A Prospective Observational Cohort Study. J Clin Med. 2025 Jan 11;14(2):434. doi: 10.3390/jcm14020434.

Reference Type DERIVED
PMID: 39860440 (View on PubMed)

Hentze M, Hougaard DD, Kingma H. Is diagnostics of Benign Paroxysmal Positional Vertigo with a mechanical rotation chair superior to traditional manual diagnostics? A randomized controlled crossover study. Front Neurol. 2024 Dec 6;15:1519837. doi: 10.3389/fneur.2024.1519837. eCollection 2024.

Reference Type DERIVED
PMID: 39711790 (View on PubMed)

Other Identifiers

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20220061

Identifier Type: -

Identifier Source: org_study_id

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