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

Not Applicable

Recruiting

• Conditions: Superior Canal Dehiscence Syndrome; Vestibular Disorder
• Interventions: Diagnostic Test: vibration induced nystagmus test

• Registration Number: NCT05967065
• Lead Sponsor: Region Stockholm

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-01
• Status Verified: 2023-07
• Study Start: 2023-07-20
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients affected by certain vestibular disorders.

Exclusion Criteria

Patients with vertigo and dizziness without certain diagnosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy control subjects	vibration induced nystagmus test	Patients without past or ongoing vestibular or balance disorders
Vestibular disorders	vibration induced nystagmus test	Patients uppfilling vestibular disorders diagnostic criterias

Primary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital, Hearing and Balance Unit; 🇸🇪 Stockholm, Sweden