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Enrolling by invitation

NCT Number: NCT07772973

Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.

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.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo (BPPV) Benign Paroxysmal Positional Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Otorhinolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Jutland, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • Typical BPPV history

Exclusion criteria

  • 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

Treatment and study plan

TRV® (Interacoustics©, Middelfart, Denmark), mechanical rotational chair

Device

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.

Primary outcomes

  1. Difference in the ability to diagnose BPPV

    Time frame: 40 minutes

    Statistically significant difference in the ability to induce nystagmus and/or vertigo between the TRV chair and Rotundum chair.

  2. Agreement on the diagnosis of BPPV in individual semicircular canals and subtype of BPPV

    Time frame: 40 minutes

    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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Diagnostic Accuracy of Benign Paroxysmal Positional Vertigo Diagnostics With Two Different Mechanical Rotation Chairs With Two Separate Diagnostic Criteria.

Acronym: ROTATE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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