Skip to main content
OpenTrials
Completed

NCT Number: NCT04147156

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

About this study

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:

  • Epley's maneuver
  • Semont maneuver
  • 360 degree vertical rotation

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Primary outcomes

  1. Number of treatments

    Time frame: 2 years

    Number of treatments necessary to achieve resolution of vertigo and nystagmus

  2. Treatment success after first treatment

    Time frame: 2 years

    Number of subjects achieving resolution of vertigo and nystagmus after one treatment

Secondary outcomes

  1. Dizziness Handicap Inventory (DHI) questionnaire

    Time frame: 2 years

    Comparison of pre- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition

  2. Adverse events

    Time frame: 2 years

    Registration of adverse events

  3. Value of liberatory nystagmus

    Time frame: 2 years

    Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Jul 29, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.