Different Treatments With the TRV Reposition Chair

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

Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?

To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.

Study Type

Interventional

Enrollment (Actual)

100

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:

  • Age above 18 years of age
  • Medical history compatible with BPPV
  • Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.

Exclusion Criteria:

  • Former treatment with a repositional Chair
  • Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Posterior canalolithiasis
Type of repositional maneuvre
Procedure: Type of repositional maneuvre
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV
EXPERIMENTAL: Lateral cupulolithiasis
Type of repositional maneuvre
Procedure: Type of repositional maneuvre
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation by VNG Measurements
Time Frame: 2 years
Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.
2 years
Subjective vertigo
Time Frame: 2 years
A systematic registration of experienced vertigo during each diagnostic procedure will take place.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory (DHI) questionnaire
Time Frame: 2 years
Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
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, Denmark

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)

January 1, 2018

Primary Completion (ACTUAL)

December 1, 2021

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (ACTUAL)

May 30, 2018

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEST01

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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