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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04147156

Enrollment

150

Registered

2019-10-31

Start date

2020-02-27

Completion date

2022-01-01

Last updated

2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPPV

Keywords

Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular diseases, Epley Maneuver, Semont Maneuver, Repositioning chair

Brief 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.

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

Interventions

PROCEDUREEpley's Maneuver

Treatment with Epley's Maneuver in the ROTUNDUM-chair

PROCEDURESemont Maneuver

Treatment with the Semont Maneuver in the ROTUNDUM-chair

PROCEDURE360 degree vertical rotation

Treatment with 360 degree vertical rotation in the ROTUNDUM-chair

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026