Benign Paroxysmal Positional VertigoBPPV-TeachingNCT06314581
Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
An observational study of Benign Paroxysmal Positional Vertigo, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Acute vertigo accounts for around 4% of emergency room visits. Triggered episodic vestibular syndrome is the most commonly encountered symptomatic context. BPPV (Benign Paroxysmal Positional Vertigo) is the main cause, representing 40-50% of the vertigo cases assessed in emergency departments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- How many people
- 382 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 1 Dec 2024
- 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: Patient older than 18 , visiting the emergency room for vertigo
Who may be able to join
- age >18
- A triggered episodic vestibular syndrome defined by vertigo that may be associated with nausea or vomiting, brief (< 1 minute) and transient, triggered by changes in head or body position;
- Or brief episodes of vertigo with no obvious cause and no spontaneous nystagmus.
- French speaking
Who cannot join
- Existence of one or more BPPV diagnostic non-compliance criteria i.e. impaired alertness (Glasgow Coma Score <15), nystagmus present in spontaneous or lateral gaze (without or with Frenzel glasses), headache or neck pain, hypoacusis concomitant with vertigo, any central neurological sign, otalgia, tinnitus, alcohol intoxication;
- Existence of one or more contraindications to performing the Dix-Hallpike test, i.e. vertebro-basilar insufficiency, recent fracture or dislocation of a cervical vertebra, cervical arthritis, recent cervical surgery, history of sino-carotid syncope;
- Patient under court protection;
- Patient under guardianship or curatorship;
- Patient deprived of liberty;
- Patients who object to the use of their data.
Trial locations and contacts
1 site in 1 country.
About this study
Acute vertigo accounts for around 4% of emergency room visits. Triggered episodic vestibular syndrome is the most commonly encountered symptomatic context. BPPV (Benign Paroxysmal Positional Vertigo) is the main cause, representing 40-50% of the vertigo cases assessed in emergency departments. It results from the migration of calcium carbonate particles (otoliths), from the sticky membrane of the utricle and saccule of the inner ear, to one of the 3 semicircular canals (SCC), posterior, horizontal or lateral, and anterior. It occurs idiopathically with head movement, through degeneration, or following head trauma. The otolith impulse causes the endolymph to move, temporarily and aberrantly displacing the cup of the affected canal, resulting in the transmission of erroneous information to the vestibular nuclei. This leads to the sudden onset of vertigo and eye deviation, resulting in transient nystagmus. The location of the displaced otoliths determines the variant of BPPV: BPPV of the posterior semicircular canal is the most common (around 65% of BPPVs), followed by BPPV of the horizontal canal, while BPPV of the anterior canal is rare, as it resolves spontaneously and rapidly. Although a benign condition, BPPV leads 9 times out of 10 to a medical consultation, interruption of daily activities, or sick leave. Untreated, it will usually recur, and can impact on patients' quality of life.
Read the detailed description
Recommendations for the appropriate management of vertigo in emergency departments published in 2023 reaffirmed that the management of BPPV is based solely on the clinic. There is no imaging test that can confirm the presence of otoliths migrating to a semicircular canal during head movement. BPPV should be suspected in the presence of an episodic vestibular syndrome triggered by head movements, and more broadly, in the presence of brief vertigo without a clear cause and without spontaneous or lateral facing nystagmus. The diagnosis of posterior BPPV is made when vertigo is accompanied by transient vertical torsional nystagmus on the Dix-Hallpike test. In some cases of BPPV, the Dix-Hallpike test produces vertigo, but not transient nystagmus. This phenomenon is known as "subjective BPPV", and may affect up to a quarter of patients suspected of having BPPV. It can be explained by a low otolith load in the affected canal, by spontaneous healing by otolith egress from the canal , but also by poor technique on the part of the clinician (slow maneuver or faulty final position). In patients with a typically positive Dix-Hallpike result or subjective BPPV, 1st-line treatment is based on a canalith repositioning maneuver. The modified Epley maneuver is the recommended one, and its efficacy is supported by numerous meta-analyses. It is significantly associated with complete resolution of symptoms after 7 days. Horizontal BPPV should be suspected by the presence of transient horizontal nystagmus in the Dix-Hallpike test. The Supine Head Roll test then confirms the diagnosis, with the appearance of vertigo and transient horizontal geo- or ageo-tropic nystagmus. The preferred treatment maneuver is Lempert's "Barbecue" maneuver. This management strategy can be summarized in a decision tree. As posterior BPPV is the most common, the appropriate use of the Dix-Hallpike and Epley maneuvers has a positive effect on a large majority of BPPV patients in emergency departments In terms of clinical decision rules, the management of vertigo has been mentioned as the 1st priority of emergency physicians . However, numerous studies have highlighted the fact that their clinical approach is often inappropriate and leads to underdiagnosis of BPPV. Under-diagnosis is generally due to failure to verify the existence of spontaneous nystagmus, under-use of the Dix-Hallpike test, or its misuse. While BPPV is a common and easily treatable condition, its diagnosis and treatment are largely delayed by a lack of theoretical knowledge and clinical skills among physicians.
Understanding the orientation of the vestibular apparatus and how it is stimulated is difficult learning. Traditional lecture-based learning appears to have little gain in terms of skill acquisition. This approach is tedious and offers little opportunity to acquire clinical skills. Theoretical resources do exist; in particular, the BPPV Viewer software, which offers 3D modeling of the vestibular apparatus, and the demonstration videos by Prof. Peter Johns available on Youtube® could provide a fairly clear theoretical basis. Proposing new teaching methods could be one way of solving the problem of sub-optimal management of BPPV and the resulting under-diagnosis. Two original teaching methods have been published, one using demonstrations involving students to teach vestibular physiology, the other based on Gagne's 9 event. The retention and transfer of knowledge to the bedside needs to be investigated.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BPPV | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
accurate BPPV diagnostics
Percentage of appropriate BPPV diagnoses, i.e., positive diagnostic tests obtained with eligible patients, before and after the educational intervention.
Positive diagnostic tests for BPPV are defined as follows:
- A Dix-Hallpike test producing triggered and transient, vertical and torsional nystagmus or isolated transient and paroxysmal vertigo (subjective BPPV) on the affected side for the appropriate diagnosis of posterior BPPV,
- A Supine Head Roll test producing a triggered and transient horizontal, geotropic or agiotropic nystagmus observed on both sides, but more intense on the healthy side, for the appropriate diagnosis of horizontal BPPV.
Measured: one year
Secondary outcomes (2)
therapeutic maneuvers performed
Percentage of therapeutic maneuvers performed (Epley and Barbecue, respectively) by trained clinicians on patients with a positive diagnostic test for BPPV, before and after the educational intervention.
Measured: 1 year
Satisfaction of clinicians who received the educational interventio
Satisfaction of clinicians who received the educational intervention at the end of their clinical management, assessed on a 5-point Likert scale.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314581
- Sponsor's protocol ID
- 673_BPPV-Teaching
- Acronym
- BPPV-Teaching
- Status last verified
- May 2024
- First submitted
- 11 Mar 2024
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
- ClinicalTrials.gov ID
- NCT06314581
- Acronym / sponsor ID
- BPPV-Teaching / 673_BPPV-Teaching
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (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.
Acute vertigo accounts for around 4% of emergency room visits. Triggered episodic vestibular syndrome is the most commonly encountered symptomatic context. BPPV (Benign Paroxysmal Positional Vertigo) is the main cause, representing 40-50% of the vertigo cases assessed in emergency departments. It results from the migration of calcium carbonate particles (otoliths), from the sticky membrane of the utricle and saccule of the inner ear, to one of the 3 semicircular canals (SCC), posterior, horizontal or lateral, and anterior. It occurs idiopathically with head movement, through degeneration, or following head trauma. The otolith impulse causes the endolymph to move, temporarily and aberrantly displacing the cup of the affected canal, resulting in the transmission of erroneous information to the vestibular nuclei. This leads to the sudden onset of vertigo and eye deviation, resulting in transient nystagmus. The location of the displaced otoliths determines the variant of BPPV: BPPV of the posterior semicircular canal is the most common (around 65% of BPPVs), followed by BPPV of the horizontal canal, while BPPV of the anterior canal is rare, as it resolves spontaneously and rapidly. Although a benign condition, BPPV leads 9 times out of 10 to a medical consultation, interruption of daily activities, or sick leave. Untreated, it will usually recur, and can impact on patients' quality of life.
Detailed description
Recommendations for the appropriate management of vertigo in emergency departments published in 2023 reaffirmed that the management of BPPV is based solely on the clinic. There is no imaging test that can confirm the presence of otoliths migrating to a semicircular canal during head movement. BPPV should be suspected in the presence of an episodic vestibular syndrome triggered by head movements, and more broadly, in the presence of brief vertigo without a clear cause and without spontaneous or lateral facing nystagmus. The diagnosis of posterior BPPV is made when vertigo is accompanied by transient vertical torsional nystagmus on the Dix-Hallpike test. In some cases of BPPV, the Dix-Hallpike test produces vertigo, but not transient nystagmus. This phenomenon is known as "subjective BPPV", and may affect up to a quarter of patients suspected of having BPPV. It can be explained by a low otolith load in the affected canal, by spontaneous healing by otolith egress from the canal , but also by poor technique on the part of the clinician (slow maneuver or faulty final position). In patients with a typically positive Dix-Hallpike result or subjective BPPV, 1st-line treatment is based on a canalith repositioning maneuver. The modified Epley maneuver is the recommended one, and its efficacy is supported by numerous meta-analyses. It is significantly associated with complete resolution of symptoms after 7 days. Horizontal BPPV should be suspected by the presence of transient horizontal nystagmus in the Dix-Hallpike test. The Supine Head Roll test then confirms the diagnosis, with the appearance of vertigo and transient horizontal geo- or ageo-tropic nystagmus. The preferred treatment maneuver is Lempert's "Barbecue" maneuver. This management strategy can be summarized in a decision tree. As posterior BPPV is the most common, the appropriate use of the Dix-Hallpike and Epley maneuvers has a positive effect on a large majority of BPPV patients in emergency departments In terms of clinical decision rules, the management of vertigo has been mentioned as the 1st priority of emergency physicians . However, numerous studies have highlighted the fact that their clinical approach is often inappropriate and leads to underdiagnosis of BPPV. Under-diagnosis is generally due to failure to verify the existence of spontaneous nystagmus, under-use of the Dix-Hallpike test, or its misuse. While BPPV is a common and easily treatable condition, its diagnosis and treatment are largely delayed by a lack of theoretical knowledge and clinical skills among physicians.
Understanding the orientation of the vestibular apparatus and how it is stimulated is difficult learning. Traditional lecture-based learning appears to have little gain in terms of skill acquisition. This approach is tedious and offers little opportunity to acquire clinical skills. Theoretical resources do exist; in particular, the BPPV Viewer software, which offers 3D modeling of the vestibular apparatus, and the demonstration videos by Prof. Peter Johns available on Youtube® could provide a fairly clear theoretical basis. Proposing new teaching methods could be one way of solving the problem of sub-optimal management of BPPV and the resulting under-diagnosis. Two original teaching methods have been published, one using demonstrations involving students to teach vestibular physiology, the other based on Gagne's 9 event. The retention and transfer of knowledge to the bedside needs to be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPPV | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient older than 18 , visiting the emergency room for vertigo
Key inclusion criteria (4 listed)
- age >18
- A triggered episodic vestibular syndrome defined by vertigo that may be associated with nausea or vomiting, brief (< 1 minute) and transient, triggered by changes in head or body position;
- Or brief episodes of vertigo with no obvious cause and no spontaneous nystagmus.
- French speaking
Key exclusion criteria (6 listed)
- Existence of one or more BPPV diagnostic non-compliance criteria i.e. impaired alertness (Glasgow Coma Score <15), nystagmus present in spontaneous or lateral gaze (without or with Frenzel glasses), headache or neck pain, hypoacusis concomitant with vertigo, any central neurological sign, otalgia, tinnitus, alcohol intoxication;
- Existence of one or more contraindications to performing the Dix-Hallpike test, i.e. vertebro-basilar insufficiency, recent fracture or dislocation of a cervical vertebra, cervical arthritis, recent cervical surgery, history of sino-carotid syncope;
- Patient under court protection;
- Patient under guardianship or curatorship;
- Patient deprived of liberty;
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
accurate BPPV diagnostics
Time frame: one year
Percentage of appropriate BPPV diagnoses, i.e., positive diagnostic tests obtained with eligible patients, before and after the educational intervention. Positive diagnostic tests for BPPV are defined as follows: * A Dix-Hallpike test producing triggered and transient, vertical and torsional nystagmus or isolated transient and paroxysmal vertigo (subjective BPPV) on the affected side for the appropriate diagnosis of posterior BPPV, * A Supine Head Roll test producing a triggered and transient horizontal, geotropic or agiotropic nystagmus observed on both sides, but more intense on the healthy side, for the appropriate diagnosis of horizontal BPPV.
2 secondary outcomes
therapeutic maneuvers performed
Time frame: 1 year
Satisfaction of clinicians who received the educational interventio
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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 Benign Paroxysmal Positional Vertigo, run by Fondation Hôpital Saint-Joseph 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 4 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 30 May 2024. 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?
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?
accurate BPPV diagnostics (time frame: one year). 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 30 May 2024.