The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

Vertigo Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05846711
• Other study ID #: 20220061
• Status: Completed
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: May 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• BPPV diagnostic
Supine Roll Test and Dix-Hallpike Test

Device:
• TRV chair
Mechanical rotational chair
• VNG goggles
Goggles for video nystagmography
• IMU sensor
A sensor that measures triaxial acceleration and triaxial angular velocity.

Procedure:
• Manual BPPV diagnostics
Bedside BPPV diagnostics

Locations

Country	Name	City	State
Denmark	Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital	Aalborg	North Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Head angulation during diagnostic bedside examination.	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 year
Secondary	Angular velocity during diagnostic bedside examination	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.	2 year