Benign Paroxysmal Positional Vertigo (BPPV)ROTATENCT07772973
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
An observational study of Benign Paroxysmal Positional Vertigo (BPPV), run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This study aims to investigate whether the diagnosis of benign paroxysmal positional vertigo (BPPV) is equally good with two different mechanical rotation chairs (MRCs) (TRV rotary chair and the Rotundum rotary chair). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV)
- What is being tested?
- TRV® (Interacoustics©, Middelfart, Denmark), mechanical rotational chair and Rotundum® (balcare GmbH©, Küsnacht, Switzerland), mechanical rotational chair.
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2026to 1 Jan 2027
- Phase
- Observational
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
Study population: Subjects are referred by their general practitioner or from a private ENT on the basis of a typical BPPV case history and/or clinical findings suggesting the presence of BPPV to examination in a rotation chair at the investigational site.
Who may be able to join
- ≥ 18 years of age
- Typical BPPV history
Who cannot join
- Unable to comply with full diagnostic procedure in TRV and Rotundum rotary chair
- Intake of 1st generation antihistamines within the last 7 days
- Intake of benzodiazepines within the last 7 days
- Known cerebral aneurysm
- Recent cerebral hemorrhagia
- Weight > 150 kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Otorhinolaryngology, Head & Neck Surgery and Audiology
Aalborg, North Jutland, 9000
About this study
Official title: Diagnostic Accuracy of Benign Paroxysmal Positional Vertigo Diagnostics With Two Different Mechanical Rotation Chairs With Two Separate Diagnostic Criteria.
This study aims to investigate whether the diagnosis of benign paroxysmal positional vertigo (BPPV) is equally good with two different mechanical rotation chairs (MRCs) (TRV rotary chair and the Rotundum rotary chair). In the study, two different diagnostic criteria will be used (the international Bárány criteria and the American Academy of Otolaryngology-Head and Neck surgery (AAO-HNS) criteria) with both MRCs.
Patients with BPPV experience brief attacks of positional vertigo. Typically, this vertigo is provoked by changes in head position relative to gravity, e.g. laying down or turning to the side from the supine position.
Previous studies on the use of MRCs have shown that MRCs offer very precise and accurate BPPV diagnostics. With MRCs it is possible to determine 1) laterality (left/right), 2) specific location (specific semicircular canal), and 3) BPPV subtype (canalolithiasis/cupulolithiasis). Treatment-wise, these MRCs have also shown to be very efficient with treatment success rates being above ninety percent. The two MRCs used in this study do not offer the exact same features (e.g. design, portability, fixed positions, and the possibility of adding kinetic energy). To the knowledge of the authors, no studies exist on direct comparison of separate MRCs. The Rotundum rotary chair, which is also the newest of the two MRCs included, has so far not been included in many studies. However, the hypothesis of the current study is that the Rotundum rotary chair and the TRV rotation chair are equally good in terms of BPPV diagnostics.
Read the detailed description
The primary aim is to investigate whether diagnostics of benign paroxysmal positional vertigo (BPPV) is equally good with two different MRCs, using both the international Bárány Society criteria and the American AAO-HNS criteria with both MRCs. Whether or not these two MRCs may be considered equally good will be evaluated based on the number of identified BPPV cases with each MRC as well as laterality (right/left), semicircular canal location (anterior/posterior/lateral) and subtype of BPPV (canalithiasis/cupulolithiasis). The participants in this study are patients with a typical BPPV history that have been referred to a University Hospital based tertiary dizziness outpatient clinic.
The following mechanical rotation chairs will be used:
- TRV® rotary chair (Interacoustics©, Middelfart, Danmark).
- Rotundum® rotary chair (balcare GmbH©, Küsnacht, Schweiz).
With MRC testing, advanced videonystagmography (VNG) glasses are used to visualize, monitor, and register eye movements. With the TRV chair, VF405® (Interacoustics©, Middelfart, Denmark) will be used with the software Micromedical VisualEyes™ (version 3.1.0.203, Interacoustics©, Middelfart, Denmark). With the Rotundum chair, the ICS Impulse® (Natus Inc©, Middleton, WA, USA) will be used with the software OTOsuite (4.88®, Natus Inc©, Middleton, WA, USA).
The same diagnostic procedure will be performed with each MRC. This includes the supine position, bilateral supine roll tests (SRTs), bilateral Dix-Hallpike tests, and, if lateral canal BPPV is ambigious, the bow and lean test. Initial MRC will be randomized.
For each participant, the following data will be collected:
- Age
- Gender
- Type and duration of symptoms
- Description of nystagmus (direction, duration, a-SPV, latency)
- Subjective vertigo during tests
- Description of BPPV (laterality, semicircular canal localization, subtype)
Sample size assessment Data will be analyzed using Cohen's Kappa. A dropout rate of 10 percent and a power of 90 percent is expected.
- Being tested
- TRV® (Interacoustics©, Middelfart, Denmark), mechanical rotational chair, Rotundum® (balcare GmbH©, Küsnacht, Switzerland), mechanical rotational chair.
- Keywords
- Benign Paroxysmal Positional Vertigo, BPPV, Mechanical Rotation Chair, Rotundum rotary chair, TRV chair, Vertigo
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV® (Interacoustics©, Middelfart, Denmark), mechanical rotational chairDevice
Diagnostic positioning maneuvers performed using the TRV® MRC to evaluate the presence, affected semicircular canal, and subtype of Benign Paroxysmal Positional Vertigo.
Rotundum® (balcare GmbH©, Küsnacht, Switzerland), mechanical rotational chair.Device
Diagnostic positioning maneuvers performed using the Rotundum® MRC to evaluate the presence, affected semicircular canal, and subtype of Benign Paroxysmal Positional Vertigo.
| Study group | Role | What they receive |
|---|---|---|
| TRV chair - Bárány Criteria | A group of participants with suspected BPPV who undergo a diagnostic procedure for BPPV in the TRV chair. The diagnosis, laterality, semicircular canal localization, and subtypes in this group are determined according to the diagnostic criteria published by the Bárány Society. Receives: Device: TRV® (Interacoustics©, Middelfart, Denmark), mechanical rotational chair | |
| Rotundum chair - Bárány Criteria | A group of participants with suspected BPPV who undergo a diagnostic procedure for BPPV in the Rotundum chair. The diagnosis, laterality, semicircular canal localization, and subtypes in this group are determined according to the diagnostic criteria published by the Bárány Society. Receives: Device: Rotundum® (balcare GmbH©, Küsnacht, Switzerland), mechanical rotational chair. | |
| TRV chair - AAO-HNS Criteria | A group of participants with suspected BPPV who undergo a diagnostic procedure for BPPV in the TRV chair. The diagnosis, laterality, semicircular canal localization, and subtypes in this group are determined according to the diagnostic AAO-HNS criteria. Receives: Device: TRV® (Interacoustics©, Middelfart, Denmark), mechanical rotational chair | |
| Rotundum chair - AAO-HNS Criteria | A group of participants with suspected BPPV who undergo a diagnostic procedure for BPPV in the Rotundum chair. The diagnosis, laterality, semicircular canal localization, and subtypes in this group are determined according to the diagnostic AAO-HNS criteria. Receives: Device: Rotundum® (balcare GmbH©, Küsnacht, Switzerland), mechanical rotational chair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the ability to diagnose BPPV
Statistically significant difference in the ability to induce nystagmus and/or vertigo between the TRV chair and Rotundum chair.
Measured: 40 minutes
Agreement on the diagnosis of BPPV in individual semicircular canals and subtype of BPPV
Statistically significant difference in the ability to induce nystagmus and/or vertigo between the TRV chair and Rotundum chair for each individual semicircular canal and for subtype of BPPV i.e. canalolithiasis or cupulolithiasis.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional Vertigo (BPPV)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Dupont Hougaard, Aalborg University Hospital
- Investigators
- Lucas Toft, BSc in Medicine, Study director, Aalborg UniversityJakob M Vandbaek, BSc in Medicine, Study director, Aalborg UniversityFredrik Lund, BSc in Medicine, Study director, Aalborg UniversityDan D Hougaard, Medical Doctor, Study director, Department of Otorhinolaryngology, Head & Neck Surgery and Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772973
- Sponsor's protocol ID
- 16-0302-144
- Acronym
- ROTATE
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krzywdzinska S, Rozbicki P, Usowski J, Jurkiewicz D. The use and effectiveness of the TRV Chair - a literature review. Otolaryngol Pol. 2023 Dec 31;77(6):31-36. doi: 10.5604/01.3001.0054.0942.
PubMed 38706261Pedersen MF, Eriksen HH, Kjaersgaard JB, Abrahamsen ER, Hougaard DD. Treatment of Benign Paroxysmal Positional Vertigo with the TRV Reposition Chair. J Int Adv Otol. 2020 Aug;16(2):176-182. doi: 10.5152/iao.2020.6320.
PubMed 32784154Abdulovski S, Klokker M. Repositioning Chairs in the Diagnosis and Treatment of Benign Paroxysmal Positional Vertigo - A Systematic Review. J Int Adv Otol. 2021 Jul;17(4):353-360. doi: 10.5152/iao.2021.9434.
PubMed 34309558Hougaard DD, Duch K, Bech MW. Treatment of posterior Benign Paroxysmal Positional Vertigo is efficient and safe with a new Mechanical Rotational Chair. Front Neurol. 2023 Aug 17;14:1239959. doi: 10.3389/fneur.2023.1239959. eCollection 2023.
PubMed 37662040Hougaard DD, Valsted SH, Bruun NH, Bech MW, Talebnasab MH. Seven years of experience with treatment of benign paroxysmal positional vertigo with a mechanical rotational chair. Front Neurol. 2022 Aug 25;13:981216. doi: 10.3389/fneur.2022.981216. eCollection 2022.
PubMed 36090886