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.
Verified date | May 2024 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital | Aalborg | North Denmark Region |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Denmark,
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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