Benign Paroxysmal Positional VertigoNCT05846711
The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.
A study testing BPPV diagnostic, TRV chair and VNG goggles in people with Benign Paroxysmal Positional Vertigo and BPPV, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo, BPPV, Vertigo
- What is being tested?
- BPPV diagnostic, TRV chair and VNG goggles
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Apr 2023to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
Aalborg, North Denmark, 9000
About this study
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.
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.
- Conditions
- Benign Paroxysmal Positional Vertigo, BPPV, Vertigo, Vestibular Disorder, Vestibular Diseases, Labyrinth Diseases
- Being tested
- BPPV diagnostic, TRV chair, VNG goggles, IMU sensor, Manual BPPV diagnostics
- Keywords
- TRV reposition chair, Dix-Hallpike maneuver, Supine Roll Test
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo, Vestibular Diseases, Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPPV diagnosticDiagnostic test
Supine Roll Test and Dix-Hallpike Test
TRV chairDevice
Mechanical rotational chair
VNG gogglesDevice
Goggles for video nystagmography
IMU sensorDevice
A sensor that measures triaxial acceleration and triaxial angular velocity.
Manual BPPV diagnosticsProcedure or surgery
Bedside BPPV diagnostics
| Study group | Role | What they receive |
|---|---|---|
| Bedside BPPV diagnostics | Active comparator | 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). Receives: Diagnostic Test: BPPV diagnostic; Device: VNG goggles; Device: IMU sensor; Procedure: Manual BPPV diagnostics |
| TRV BPPV diagnostics | Active comparator | Diagnostics of BPPV using the TRV chair. Receives: Diagnostic Test: BPPV diagnostic; Device: TRV chair; Device: VNG goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.
Measured: 2 year
Secondary outcomes (2)
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.
Measured: 2 year
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start12 Apr 2023
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Hentze Hansen, Aalborg University Hospital
- Investigators
- Malene Hentze Hansen, MD, Principal investigator, Department of Otolaryngology, Head & Neck Surgery and Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846711
- Sponsor's protocol ID
- 20220061
- Status last verified
- May 2024
- First submitted
- 17 Apr 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hentze M, Hougaard DD, Kingma H. Impact of head orientation and head movement in traditional manual diagnostics of benign paroxysmal positional vertigo: a randomized controlled crossover study. Front Neurol. 2025 Oct 3;16:1654404. doi: 10.3389/fneur.2025.1654404. eCollection 2025.
PubMed 41111959Hentze M, Hougaard DD, Kingma H. The Intra-Examiner Variability in and Accuracy of Traditional Manual Diagnostics of Benign Paroxysmal Positional Vertigo: A Prospective Observational Cohort Study. J Clin Med. 2025 Jan 11;14(2):434. doi: 10.3390/jcm14020434.
PubMed 39860440Hentze M, Hougaard DD, Kingma H. Is diagnostics of Benign Paroxysmal Positional Vertigo with a mechanical rotation chair superior to traditional manual diagnostics? A randomized controlled crossover study. Front Neurol. 2024 Dec 6;15:1519837. doi: 10.3389/fneur.2024.1519837. eCollection 2024.
PubMed 39711790
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05846711
- Acronym / sponsor ID
- 20220061
- Conditions
- Benign Paroxysmal Positional Vertigo, BPPV, Vertigo, Vestibular Disorder, Vestibular Diseases, Labyrinth Diseases
- Keywords
- TRV reposition chair, Dix-Hallpike maneuver, Supine Roll Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedside BPPV diagnostics | Active comparator | Diagnostic Test: BPPV diagnostic, Device: VNG goggles, Device: IMU sensor, Procedure: Manual BPPV diagnosticsDiagnostics 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). |
| TRV BPPV diagnostics | Active comparator | Diagnostic Test: BPPV diagnostic, Device: TRV chair, Device: VNG gogglesDiagnostics of BPPV using the TRV chair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPPV diagnosticSupine Roll Test and Dix-Hallpike Test | Diagnostic test | Bedside BPPV diagnostics, TRV BPPV diagnostics |
| TRV chairMechanical rotational chair | Device | TRV BPPV diagnostics |
| VNG gogglesGoggles for video nystagmography | Device | Bedside BPPV diagnostics, TRV BPPV diagnostics |
| IMU sensorA sensor that measures triaxial acceleration and triaxial angular velocity. | Device | Bedside BPPV diagnostics |
| Manual BPPV diagnosticsBedside BPPV diagnostics | Procedure or surgery | Bedside BPPV diagnostics |
Primary outcome
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.
2 secondary outcomes
Head angulation during diagnostic bedside examination.
Time frame: 2 year
Angular velocity during diagnostic bedside examination
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 41111959Hentze M, Hougaard DD, Kingma H. Impact of head orientation and head movement in traditional manual diagnostics of benign paroxysmal positional vertigo: a randomized controlled crossover study. Front Neurol. 2025 Oct 3;16:1654404. doi: 10.3389/fneur.2025.1654404. eCollection 2025.
- Derived from this study: PubMed 39860440Hentze M, Hougaard DD, Kingma H. The Intra-Examiner Variability in and Accuracy of Traditional Manual Diagnostics of Benign Paroxysmal Positional Vertigo: A Prospective Observational Cohort Study. J Clin Med. 2025 Jan 11;14(2):434. doi: 10.3390/jcm14020434.
- Derived from this study: PubMed 39711790Hentze M, Hougaard DD, Kingma H. Is diagnostics of Benign Paroxysmal Positional Vertigo with a mechanical rotation chair superior to traditional manual diagnostics? A randomized controlled crossover study. Front Neurol. 2024 Dec 6;15:1519837. doi: 10.3389/fneur.2024.1519837. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malene Hentze Hansen, MD principal investigator
Department of Otolaryngology, Head & Neck Surgery and Audiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPPV diagnostic, TRV chair and VNG goggles in people with Benign Paroxysmal Positional Vertigo and BPPV, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846711, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.