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Completed

NCT Number: NCT05846711

The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

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.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo BPPV Ear Diseases Inner Ear Disease Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases Vestibular Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPPV diagnostic

Diagnostic Test

Supine Roll Test and Dix-Hallpike Test

TRV chair

Device

Mechanical rotational chair

VNG goggles

Device

Goggles for video nystagmography

IMU sensor

Device

A sensor that measures triaxial acceleration and triaxial angular velocity.

Manual BPPV diagnostics

Procedure

Bedside BPPV diagnostics

Primary outcomes

  1. Diagnostic Accuracy

    Time frame: 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 outcomes

  1. Head angulation during diagnostic bedside examination.

    Time frame: 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.

  2. Angular velocity during diagnostic bedside examination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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