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

July 28, 2022 updated by: Dan Dupont Hougaard, Aalborg University Hospital

Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • North Denmark Region
      • Aalborg, North Denmark Region, Denmark, 9000
        • Department of Otolaryngology, Head & Neck Surgery and Audiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success after first treatment
Time Frame: 2 years
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
2 years
Number of treatments
Time Frame: 2 years
Number of treatments necessary to achieve resolution of vertigo and nystagmus
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 2 years
Registration of adverse events
2 years
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 years
Value of liberatory nystagmus
Time Frame: 2 years
Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Dan D Hougaard, MD, Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ROTDUNDUM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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