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

A

Aalborg University Hospital

Status

Completed

Conditions

BPPV

Treatments

Procedure: 360 degree vertical rotation
Procedure: Epley's Maneuver
Procedure: Semont Maneuver

Study type

Interventional

Funder types

Other

Identifiers

NCT04147156
ROTDUNDUM1

Details and patient eligibility

About

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.

Full 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

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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