Superior Canal Dehiscence SyndromeVIN by B250NCT05967065
Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol
A study testing vibration induced nystagmus test in people with Superior Canal Dehiscence Syndrome and Vestibular Disorder, run by Region Stockholm at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Superior Canal Dehiscence Syndrome, Vestibular Disorder
- What is being tested?
- vibration induced nystagmus test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients affected by certain vestibular disorders.
Who cannot join
- Patients with vertigo and dizziness without certain diagnosis.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital, Hearing and Balance Unit
Stockholm, 14186
About this study
Official title: 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
- Being tested
- vibration induced nystagmus test
- Medical subject headings
- Semicircular Canal Dehiscence, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibration induced nystagmus testDiagnostic test
Vibration induced nystagmus test by bone transducer B250.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular disorders | Other | Patients uppfilling vestibular disorders diagnostic criterias Receives: Diagnostic Test: vibration induced nystagmus test |
| healthy control subjects | Other | Patients without past or ongoing vestibular or balance disorders Receives: Diagnostic Test: vibration induced nystagmus test |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of eye movements
angular velocity of eye movements during skull vibration.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start20 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Technical issues in testing procedure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Canal Dehiscence SyndromeStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luca Verrecchia, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967065
- Sponsor's protocol ID
- RegionStockholm
- Acronym
- VIN by B250
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone
- ClinicalTrials.gov ID
- NCT05967065
- Acronym / sponsor ID
- VIN by B250 / RegionStockholm
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Technical issues in testing procedure
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular disorders | Other | Diagnostic Test: vibration induced nystagmus testPatients uppfilling vestibular disorders diagnostic criterias |
| healthy control subjects | Other | Diagnostic Test: vibration induced nystagmus testPatients without past or ongoing vestibular or balance disorders |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients affected by certain vestibular disorders.
Key exclusion criteria (1 listed)
- Patients with vertigo and dizziness without certain diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibration induced nystagmus testVibration induced nystagmus test by bone transducer B250. | Diagnostic test | Vestibular disorders, healthy control subjects |
Primary outcome
measure of eye movements
Time frame: through study completion, an average of 18 months
angular velocity of eye movements during skull vibration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
Related trials for Superior Canal Dehiscence Syndrome
Not yet recruiting
The Diagnostic Accuracy of Ankle Audiometry Performed With the B250 for Superior Canal Dehiscence Syndrome in Patients Affected by Pulsatile Tinnitus and/or Autophony Disorders
Superior Canal Dehiscence Syndrome, Autophony
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibration induced nystagmus test in people with Superior Canal Dehiscence Syndrome and Vestibular Disorder, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of eye movements (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.