ClinicalTrials.gg
Sign In
CompletedNCT05846711Updated May 16, 2024

The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

An interventional study of BPPV diagnostic and TRV chair in Benign Paroxysmal Positional Vertigo, BPPV and Vertigo, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • 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
03

In context

Benign Paroxysmal Positional Vertigo

75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's enrollment of 215 is above the median of 78 across 62 interventional studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.

Browse Aalborg University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
215 participants (actual)

Study arms

  • Active comparator
    Bedside BPPV diagnostics

    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

  • Active comparator
    TRV BPPV diagnostics

    Diagnostics of BPPV using the TRV chair.

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

Interventions

  • Diagnostic testBPPV diagnostic

    Supine Roll Test and Dix-Hallpike Test

  • DeviceTRV chair

    Mechanical rotational chair

  • DeviceVNG goggles

    Goggles for video nystagmography

  • DeviceIMU sensor

    A sensor that measures triaxial acceleration and triaxial angular velocity.

  • ProcedureManual BPPV diagnostics

    Bedside BPPV diagnostics

06

What researchers measure

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.

    Time frame: 2 year

Secondary outcomes

  1. 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.

    Time frame: 2 year

  2. 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.

    Time frame: 2 year

07

Study locations

1 site
  • Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
    Aalborg, North Denmark Region 9000, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Jan 2024, 8 months.

Of 38 non-industry interventional studies with no phase under Benign Paroxysmal Positional Vertigo, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's 8 months is below that.

Counting every sponsor, half of 39 studies reached it within 16 months; a quarter within 8 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2023
First posted
May 6, 2023
StartActual
Apr 12, 2023
Primary completionActual
Jan 11, 2024
CompletionActual
Jan 11, 2024
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05846711
Lead sponsor
Aalborg University Hospital
Responsible party
Malene Hentze Hansen (Principal Investigator, Aalborg University Hospital) — Principal investigator
First posted
May 6, 2023
Start date
Apr 12, 2023
Primary completion
Jan 11, 2024
Completion
Jan 11, 2024
Last update
May 16, 2024

Study contacts

Malene Hentze Hansen, MD
principal investigator · Department of Otolaryngology, Head & Neck Surgery and Audiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Benign Paroxysmal Positional Vertigo →

Other studies from this sponsor

Aalborg University Hospital →

Start the discussion