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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05846711
Other study ID # 20220061
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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