ED With VertigoVERTIGONCT07287891
Lost in the Labyrinth: Predicting Central Neurological Causes of Vertigo Dizziness and Unsteadiness in the Emergency Department. A Multicentre Cross-sectional Observational Study
An observational study of ED With Vertigo and Dizziness, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
This study will assess the sensitivity and specificity of the bedside examination algorithm performed by ED physicians. Finally, it aims to identify predictors of a central cause of the symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ED With Vertigo, Dizziness, Unsteadiness
- What is being tested?
- Bedside examination of Vertigo
- How many people
- 825 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2024to 26 Feb 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at the ED with vertigo, dizziness or unsteadiness
Who may be able to join
- Patients presenting at the ED with vertigo, dizziness or unsteadiness
- >= 18 years of age
- Patients able to give their consent
Who cannot join
- Patients with dementia
- Bedridden patients (for causes other than the current symptoms)
- Patients with obvious neurological findings presenting with vertigo but with suspected stroke at triage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Pronto Soccorso e Medicina d'Urgenza, Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Marco Bonzano, MD, +390380502039, m.bonzano@smatteo.pv.it
About this study
This study will assess the sensitivity and specificity of the bedside examination algorithm performed by ED physicians. Finally, it aims to identify predictors of a central cause of the symptoms. This will consequently reduce the rate of misdiagnosis as well as the costs and length of stay due to inappropriate neuroimaging.
- Conditions
- ED With Vertigo, Dizziness, Unsteadiness
- Being tested
- Bedside examination of Vertigo
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside examination of VertigoDiagnostic test
ED visit comprehensive of bedside examination of vertigo performed by trained EP or emergency medicine residents
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting at the ED with vertigo, dizziness, and unsteadiness | Patients presenting to the ED with vertigo/ dizziness Receives: Diagnostic Test: Bedside examination of Vertigo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The AUC of the bedside examination algorithm performed by ED physicians
Measured: up to 36 months
Secondary outcomes (2)
identification of predictors of true positive patients
Predictors of true positive patients can help to stratify patients with vertigo for the risk of stroke.
Measured: up to 36 months
evaluation of number of neuroimaging tests (TC and angio-TC) performed to patients with vertigo in the ED.tests performed
to study the use of ED resources for these patients in terms of number of neuroimaging tests performed.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start26 Jan 2024
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ED With VertigoStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Bonzano, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287891
- Sponsor's protocol ID
- VERTIGO
- Acronym
- VERTIGO
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lost in the Labyrinth: Predicting Central Neurological Causes of Vertigo Dizziness and Unsteadiness in the Emergency Department. A Multicentre Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT07287891
- Acronym / sponsor ID
- VERTIGO / VERTIGO
- Conditions
- ED With Vertigo, Dizziness, Unsteadiness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
This study will assess the sensitivity and specificity of the bedside examination algorithm performed by ED physicians. Finally, it aims to identify predictors of a central cause of the symptoms. This will consequently reduce the rate of misdiagnosis as well as the costs and length of stay due to inappropriate neuroimaging.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting at the ED with vertigo, dizziness, and unsteadiness | – | Diagnostic Test: Bedside examination of VertigoPatients presenting to the ED with vertigo/ dizziness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at the ED with vertigo, dizziness or unsteadiness
Key inclusion criteria (3 listed)
- Patients presenting at the ED with vertigo, dizziness or unsteadiness
- >= 18 years of age
- Patients able to give their consent
Key exclusion criteria (3 listed)
- Patients with dementia
- Bedridden patients (for causes other than the current symptoms)
- Patients with obvious neurological findings presenting with vertigo but with suspected stroke at triage
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 |
|---|---|---|
| Bedside examination of VertigoED visit comprehensive of bedside examination of vertigo performed by trained EP or emergency medicine residents | Diagnostic test | Patients presenting at the ED with vertigo, dizziness, and unsteadiness |
Primary outcome
The AUC of the bedside examination algorithm performed by ED physicians
Time frame: up to 36 months
2 secondary outcomes
identification of predictors of true positive patients
Time frame: up to 36 months
evaluation of number of neuroimaging tests (TC and angio-TC) performed to patients with vertigo in the ED.tests performed
Time frame: up to 36 months
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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.
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 ED With Vertigo and Dizziness, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 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 Italy. 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?
Contact Marco Bonzano, MD (+390382502039, m.bonzano@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AUC of the bedside examination algorithm performed by ED physicians (time frame: up to 36 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 Dec 2025.