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

NCT05967065 | Suspended

• 1 other identifier: RegionStockholm
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Superior Canal Dehiscence Syndrome; Vestibular Disorder

Outcome Measures

Primary Outcomes (1)

• measure of eye movements

  angular velocity of eye movements during skull vibration.

  through study completion, an average of 18 months

Study Arms (2)

Vestibular disorders

OTHER

Patients uppfilling vestibular disorders diagnostic criterias

Diagnostic Test: vibration induced nystagmus test

healthy control subjects

OTHER

Patients without past or ongoing vestibular or balance disorders

Diagnostic Test: vibration induced nystagmus test

Interventions

vibration induced nystagmus test DIAGNOSTIC_TEST

Vibration induced nystagmus test by bone transducer B250.

Vestibular disorders; healthy control subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by certain vestibular disorders.

You may not qualify if:

• Patients with vertigo and dizziness without certain diagnosis.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital, Hearing and Balance Unit

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Semicircular Canal Dehiscence; Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: August 1, 2023
• Study Start: July 20, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

SE (1)