Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV

NCT04147156 — Not applicable, Completed, 150 participants, Aalborg University Hospital

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Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) in Treating BPPV

Registry	NCT04147156
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	150 (Actual)
Sponsor	Aalborg University Hospital (Other)
Conditions	BPPV
Interventions	Epley's Maneuver, Semont Maneuver, 360 degree vertical rotation (Procedure)
Dates	start 2020-02-27, primary completion 2022-01-01, completion 2022-01-01, first posted 2019-10-31, last updated 2022-07-29
Locations	1 site in Denmark

-Summary

A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.

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+Detailed description

Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair:

1. Epley's maneuver
2. Semont maneuver
3. 360 degree vertical rotation

+Arms and interventions

Arm	Type	Interventions	Description
Epley's Maneuver	Active comparator	Procedure: Epley's Maneuver	Treatment of posterior canal BPPV with Epley's maneuver in the ROTUNDUM-chair.
Semont Maneuver	Experimental	Procedure: Semont Maneuver	Treatment of posterior canal BPPV with the Semont maneuver in the ROTUNDUM-chair.
360 degree vertical rotation	Active comparator	Procedure: 360 degree vertical rotation	Treatment of posterior canal BPPV with a 360 degree vertical rotation in the ROTUNDUM-chair.

Epley's Maneuver (Procedure): Treatment with Epley's Maneuver in the ROTUNDUM-chair
Semont Maneuver (Procedure): Treatment with the Semont Maneuver in the ROTUNDUM-chair
360 degree vertical rotation (Procedure): Treatment with 360 degree vertical rotation in the ROTUNDUM-chair

+Outcome measures

Primary outcomes

Number of treatments [2 years]: Number of treatments necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment [2 years]: Number of subjects achieving resolution of vertigo and nystagmus after one treatment

Secondary outcomes

Dizziness Handicap Inventory (DHI) questionnaire [2 years]: Comparison of pre- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition
Adverse events [2 years]: Registration of adverse events
Value of liberatory nystagmus [2 years]: Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Characteristic (for BPPV) positional nystagmus
* Positive Dix-Hallpike Test
* Medical history compatible with BPPV

Exclusion Criteria:

* Treatment in a mechanical rotational chair within the last 6 months
* Exclusion of BPPV diagnosis
* Lack of treatment cooperation
* Known cerebral aneurism or cerebral hemorrhage
* Treated for BPPV within the past month

+Locations (1)

Facility	City	Country	Status
Department of Otolaryngology, Head & Neck Surgery and Audiology	Aalborg, North Denmark	Denmark

+Publications

Results publication: Hougaard DD, Vorm B, Skals RG, Holm J, Thrane JF, Luscher M. A mechanical rotation chair provides superior diagnostics of benign paroxysmal positional vertigo amongst elderly. Front Neurol. 2026 Jul 15;17:1873559. doi: 10.3389/fneur.2026.1873559. eCollection 2026. PMID 42529276

+Investigators

Dan D Hougaard, MD, Principal investigator, Aalborg University Hospital