Back to resultsDiagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol (VIN by B250)
Primary Purpose
Superior Canal Dehiscence Syndrome, Vestibular Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
vibration induced nystagmus test
Sponsored by
About this trial
This is an interventional diagnostic trial for Superior Canal Dehiscence Syndrome
Eligibility Criteria
Inclusion Criteria: Patients affected by certain vestibular disorders. Exclusion Criteria: Patients with vertigo and dizziness without certain diagnosis.
Sites / Locations
- Karolinska University Hospital, Hearing and Balance UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Vestibular disorders
healthy control subjects
Arm Description
Patients uppfilling vestibular disorders diagnostic criterias
Patients without past or ongoing vestibular or balance disorders
Outcomes
Primary Outcome Measures
measure of eye movements
angular velocity of eye movements during skull vibration.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05967065
Brief Title
Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol
Acronym
VIN by B250
Official Title
Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Stockholm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superior Canal Dehiscence Syndrome, Vestibular Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vestibular disorders
Arm Type
Other
Arm Description
Patients uppfilling vestibular disorders diagnostic criterias
Arm Title
healthy control subjects
Arm Type
Other
Arm Description
Patients without past or ongoing vestibular or balance disorders
Intervention Type
Diagnostic Test
Intervention Name(s)
vibration induced nystagmus test
Intervention Description
Vibration induced nystagmus test by bone transducer B250.
Primary Outcome Measure Information:
Title
measure of eye movements
Description
angular velocity of eye movements during skull vibration.
Time Frame
through study completion, an average of 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients affected by certain vestibular disorders.
Exclusion Criteria:
Patients with vertigo and dizziness without certain diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Verrecchia, MD PhD
Phone
+46724654523
Email
luca.verrecchia@ki.se
Facility Information:
Facility Name
Karolinska University Hospital, Hearing and Balance Unit
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Verrecchia, MD PhD
Phone
0046724654523
Email
luca.verrecchia@ki.se
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol
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