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

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: Vestibular Disorder; Superior Canal Dehiscence Syndrome
• Intervention / Treatment: Diagnostic test: vibration induced nystagmus test

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	angular velocity of eye movements during skull vibration.	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: Region Stockholm

Study record dates

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: Otorhinolaryngologic Diseases; Ear Diseases; Labyrinth Diseases; Semicircular Canal Dehiscence; Vestibular Diseases
• 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