VertigoBCVEMP By B250NCT05889676
Validation of a Simultaneous Ocular/Cervical VEMP With Mastoid Vibration by B250
An observational study of Vertigo, run by Region Stockholm at 1 site in Sweden.
Trial summary
A Validation study in which the standard separate cVEMP and oVEMP will be compared with a new protocol in which the cVEMP and oVEMP can be recorded simultaneously in response to a mastoid vibration by bone transducer B250 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vertigo
- What is being tested?
- VEMP by bone conduction
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 30 May 2023to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all adult patients attedning the balance laboratory at Karolinska University Hospital after written consent.
Who may be able to join
- -) dizzy patients attending the balance laboratory -
Who cannot join
- -) age < 18 years old
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital, Hearing and Balance Unit
Stockholm, 14186
About this study
A Validation study in which the standard separate cVEMP and oVEMP will be compared with a new protocol in which the cVEMP and oVEMP can be recorded simultaneously in response to a mastoid vibration by bone transducer B250
- Conditions
- Vertigo
- Being tested
- VEMP by bone conduction
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEMP by bone conductionDiagnostic test
New bone conducted VEMP elicited by transducer B250
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start30 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
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
- NCT05889676
- Sponsor's protocol ID
- K2023-3904
- Acronym
- BCVEMP By B250
- Status last verified
- Jul 2025
- First submitted
- 16 May 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Simultaneous Ocular/Cervical VEMP With Mastoid Vibration by B250
- ClinicalTrials.gov ID
- NCT05889676
- Acronym / sponsor ID
- BCVEMP By B250 / K2023-3904
- Conditions
- Vertigo
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 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.
A Validation study in which the standard separate cVEMP and oVEMP will be compared with a new protocol in which the cVEMP and oVEMP can be recorded simultaneously in response to a mastoid vibration by bone transducer B250
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all adult patients attedning the balance laboratory at Karolinska University Hospital after written consent.
Key inclusion criteria (1 listed)
- -) dizzy patients attending the balance laboratory -
Key exclusion criteria (1 listed)
- -) age < 18 years old
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 |
|---|---|---|
| VEMP by bone conductionNew bone conducted VEMP elicited by transducer B250 | Diagnostic test | – |
Primary outcome
response rate
Time frame: during the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
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Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
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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?
An observational study of Vertigo, 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: under way, not looking for participants, as of the sponsor's last update on 15 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?
This study is still under way. Results are not available in the source record yet.
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?
response rate (time frame: during the procedure). 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 15 Jul 2025.