The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

NCT05846711 | Completed

• 1 other identifier: 20220061
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

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

  2 year

Secondary Outcomes (2)

• Head angulation during diagnostic bedside examination.

  2 year

• Angular velocity during diagnostic bedside examination

  2 year

Study Arms (2)

Bedside BPPV diagnostics

ACTIVE COMPARATOR

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; Device: VNG goggles; Device: IMU sensor; Procedure: Manual BPPV diagnostics

TRV BPPV diagnostics

ACTIVE COMPARATOR

Diagnostics of BPPV using the TRV chair.

Diagnostic Test: BPPV diagnostic; Device: TRV chair; Device: VNG goggles

Interventions

BPPV diagnostic DIAGNOSTIC_TEST

Supine Roll Test and Dix-Hallpike Test

Bedside BPPV diagnostics; TRV BPPV diagnostics

TRV chair DEVICE

Mechanical rotational chair

TRV BPPV diagnostics

VNG goggles DEVICE

Goggles for video nystagmography

Bedside BPPV diagnostics; TRV BPPV diagnostics

IMU sensor DEVICE

A sensor that measures triaxial acceleration and triaxial angular velocity.

Bedside BPPV diagnostics

Manual BPPV diagnostics PROCEDURE

Bedside BPPV diagnostics

Bedside BPPV diagnostics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

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

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (3)

• 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.

  PMID: 41111959 DERIVED

• 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.

  PMID: 39860440 DERIVED

• 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.

  PMID: 39711790 DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo; Vestibular Diseases; Labyrinth Diseases

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Malene Hentze Hansen, MD

  Department of Otolaryngology, Head & Neck Surgery and Audiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 6, 2023
• Study Start: April 12, 2023
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)