NCT06314581

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

March 11, 2024

Last Update Submit

May 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (2)

  • therapeutic maneuvers performed

    1 year

  • Satisfaction of clinicians who received the educational interventio

    one year

Study Arms (1)

BPPV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient older than 18 , visiting the emergency room for vertigo

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

December 1, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations