NCT07772973

Brief 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). 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 14, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

Benign Paroxysmal Positional VertigoBPPVMechanical Rotation ChairRotundum rotary chairTRV chairVertigo

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    40 minutes

Study Arms (4)

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.

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.

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.

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.

Device: Rotundum® (balcare GmbH©, Küsnacht, Switzerland), mechanical rotational chair.

Interventions

Diagnostic positioning maneuvers performed using the TRV® MRC to evaluate the presence, affected semicircular canal, and subtype of Benign Paroxysmal Positional Vertigo.

TRV chair - AAO-HNS CriteriaTRV chair - Bárány Criteria

Diagnostic positioning maneuvers performed using the Rotundum® MRC to evaluate the presence, affected semicircular canal, and subtype of Benign Paroxysmal Positional Vertigo.

Rotundum chair - AAO-HNS CriteriaRotundum chair - Bárány Criteria

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ≥ 18 years of age
  • Typical BPPV history

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otorhinolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Jutland, 9000, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 38706261BACKGROUND
  • Pedersen 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.

    PMID: 32784154BACKGROUND
  • Abdulovski 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.

    PMID: 34309558BACKGROUND
  • Hougaard 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.

    PMID: 37662040BACKGROUND
  • Hougaard 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.

    PMID: 36090886BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lucas Toft, BSc in Medicine

    Aalborg University

    STUDY DIRECTOR
  • Jakob M Vandbaek, BSc in Medicine

    Aalborg University

    STUDY DIRECTOR
  • Fredrik Lund, BSc in Medicine

    Aalborg University

    STUDY DIRECTOR
  • Dan D Hougaard, Medical Doctor

    Department of Otorhinolaryngology, Head & Neck Surgery and Audiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician and Associate Professor

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations