Vestibular NeuritisNEVRITENCT04926363
Prevalence of Cardiovascular Risk Factors in Upper Vestibular Neuritis
An observational study of Vestibular Neuritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Vestibular neuritis is the second cause of vertigo, it constitutes 5 to 6% of the aetiologies of vertigo in an otoneurological consultation. Infection or reactivation of a neurotropic virus of the herpes group (HSV-1) in the vestibular lymph node is thought to be the cause of the unilateral vestibular deficit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Neuritis
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 4 Feb 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major having presented an episode of upper vestibular neuritis recorded on the Video Head Impulse Test Ulmer device at the HUS between 01/01/2016 and 01/31/2020,
Who may be able to join
None listed.
Who cannot join
- Patient who expressed his opposition to participating in the study,
- Total vestibular neuritis,
- impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
- Subject under safeguard of justice,
- Subject under guardianship or guardianship,
- Lack of video head impulse test data.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service ORL et de CCF - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Anne CHARPIOT, MD, PhD, 33 3 88 12 76 41, anne.charpiot@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Prevalence of Cardiovascular Risk Factors in People With Upper Vestibular Neuritis
Vestibular neuritis is the second cause of vertigo, it constitutes 5 to 6% of the aetiologies of vertigo in an otoneurological consultation.
Infection or reactivation of a neurotropic virus of the herpes group (HSV-1) in the vestibular lymph node is thought to be the cause of the unilateral vestibular deficit.
Read more
Upper vestibular neuritis is more common than lower, or total involvement. Goebel (2) explains this by an anatomical predisposition of the vestibular nerve canal to inflammation, unlike the singular nerve canal which is shorter and wider giving way to a certain degree of edema without consequence on its contents.
However, the innervation territory of the superior vestibular nerve is superimposable on the territory supplied by the anterior vestibular artery. The anterior, lateral semicircular canals and the utricle are affected. Current complementary vestibular and imaging examinations cannot differentiate between inflammatory or vascular involvement in upper vestibular neuritis.
The increased presence of cardiovascular risk factors in patients with upper vestibular neuritis would be an argument in favor of ischemic involvement of the anterior vestibular artery.
- Conditions
- Vestibular Neuritis
- Keywords
- Vestibular neuritis, Anterior vestibular artery
- Medical subject headings
- Vestibular Neuronitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of cardiovascular risk factors in people with upper vestibular neuritis
Measured: Files analysed retrospectively from January 01, 2016 to January 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Feb 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion4 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular NeuritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CHARPIOT, MD, PhD, Study director, Service ORL et de CCF- Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926363
- Sponsor's protocol ID
- 7665
- Acronym
- NEVRITE
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 7 Oct 2021
- 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 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiovascular Risk Factors in People With Upper Vestibular Neuritis
- ClinicalTrials.gov ID
- NCT04926363
- Acronym / sponsor ID
- NEVRITE / 7665
- Conditions
- Vestibular Neuritis
- Keywords
- Vestibular neuritis, Anterior vestibular artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 4 Feb 2022 (estimated)
- First posted
- 15 Jun 2021 (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.
Vestibular neuritis is the second cause of vertigo, it constitutes 5 to 6% of the aetiologies of vertigo in an otoneurological consultation.
Infection or reactivation of a neurotropic virus of the herpes group (HSV-1) in the vestibular lymph node is thought to be the cause of the unilateral vestibular deficit.
Upper vestibular neuritis is more common than lower, or total involvement. Goebel (2) explains this by an anatomical predisposition of the vestibular nerve canal to inflammation, unlike the singular nerve canal which is shorter and wider giving way to a certain degree of edema without consequence on its contents.
However, the innervation territory of the superior vestibular nerve is superimposable on the territory supplied by the anterior vestibular artery. The anterior, lateral semicircular canals and the utricle are affected. Current complementary vestibular and imaging examinations cannot differentiate between inflammatory or vascular involvement in upper vestibular neuritis.
The increased presence of cardiovascular risk factors in patients with upper vestibular neuritis would be an argument in favor of ischemic involvement of the anterior vestibular artery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major having presented an episode of upper vestibular neuritis recorded on the Video Head Impulse Test Ulmer device at the HUS between 01/01/2016 and 01/31/2020,
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patient who expressed his opposition to participating in the study,
- Total vestibular neuritis,
- impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
- Subject under safeguard of justice,
- Subject under guardianship or guardianship,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of cardiovascular risk factors in people with upper vestibular neuritis
Time frame: Files analysed retrospectively from January 01, 2016 to January 31, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
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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.
Anne CHARPIOT, MD, PhD study director
Service ORL et de CCF- Hôpitaux Universitaires de Strasbourg
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 Vestibular Neuritis, run by University Hospital, Strasbourg, France at 1 site in France.
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 0 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Oct 2021. 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 France. 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?
Contact Anne CHARPIOT, MD, PhD (33 3 88 12 76 41, anne.charpiot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of cardiovascular risk factors in people with upper vestibular neuritis (time frame: Files analysed retrospectively from January 01, 2016 to January 31, 2020 will be examined]). 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 7 Oct 2021.