Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol (VIN by B250)

July 14, 2025 updated by: Luca Verrecchia, Region Stockholm

Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone

to study the videonystagmography response to a bone conducted vibration on the mastoid by B250 bone transducer in patients affected by vestibular loss, Menieres disease and Superior Semicircular Canal Dehiscence Syndrome vs healthy control subjects

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital, Hearing and Balance Unit

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patients affected by certain vestibular disorders.

Exclusion Criteria:

Patients with vertigo and dizziness without certain diagnosis.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vestibular disorders
Patients uppfilling vestibular disorders diagnostic criterias
Diagnostic test: vibration induced nystagmus test
Vibration induced nystagmus test by bone transducer B250.
Other: healthy control subjects
Patients without past or ongoing vestibular or balance disorders
Diagnostic test: vibration induced nystagmus test
Vibration induced nystagmus test by bone transducer B250.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure of eye movements
Time Frame: through study completion, an average of 18 months
angular velocity of eye movements during skull vibration.
through study completion, an average of 18 months

Collaborators and Investigators

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

Sponsor

Region Stockholm

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)

July 20, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegionStockholm

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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