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Completed

NCT Number: NCT05176015

Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo

This pilot study is perfomed to validate and document faisability of the use of Frenzel lens and the use of a diagnostic algorithm for the assessment of a special sign (nystagmus) observe in the eyes of patients consulting in the emergency department (ED) for an acute episode of vertigo/dizziness/imbalance.

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Key information

Conditions

Nystagmus, Acquired Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cranial Nerve Diseases Eye Diseases Nervous System Diseases Nystagmus, Pathologic Ocular Motility Disorders Stroke Stroke, Acute Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Amqui, Amqui, Quebec, Canada

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About this study

This pilot study is a randomized controlled trial 2 by 2 design to allocated randomly the Frenzel lens and the diagnostic algorithm. There is no use of sham lens. The usual care opposed to the diagnostic algorithm will be questioned only on the perception of nystagmus by the clinician and the use of repositioning particles technique. The only blinding will be the patients about the use of the algorithm and the outcomes assessor about the use or not of Frenzel lens and the use or not of the diagnostic algorithm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days
  • Must be able to consent.

Exclusion criteria

  • No traumatic context before symptoms onset
  • No intoxication context
  • Glycemia ≤ 3,0 mmol/L
  • Only one participation is permitted
  • Not able to speak adequately in French or English.
  • Reachable for 3 month follow-up

Treatment and study plan

Frenzel Lens

Device

pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation.

Diagnostic Algorithm

Diagnostic Test

A diagnostic algorithm using the TiTrate approach: continuous, Intermittent, trigger or spontaneous.

The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different maneuvers: HINTS+ battery, Dix-Hallpike test, Supine Roll test.

Different Particle Repositioning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvers.

Risk Score is used to assess stroke risk for transient ischaemic attack (TIA): ABCD2 and the Canadian TIA Risk Score

Primary outcomes

  1. Rate of Nystagmus detection per participant

    Time frame: Day 0

    During eye examination, nystagmus will be characterized according to prominent direction of the fast phase (patients' left, patients' right, up, down, rotational),with their clinical setting or trigger. Overall rate of nystagmus detection by participant. (Rate of typical nystagmus for benign paroxysmal positional vertigo in the Dix-Hallpike maneuver or Supine Head Roll Test. Rate of nystagmus detection in the initial physical exam)

Secondary outcomes

  1. Emergency Department Length of stay

    Time frame: Day 0, from triage time to Emergency Department departure (admission or home discharge)

    Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours

  2. Rate of neuro-imaging per participant

    Time frame: From day 0 to 12 weeks

    Any imaging to investigate acute intra-cerebral lesion and/or the neck/brain vascular. anomaly : computed tomography imaging; computed tomography angiogram; magnetic resonance angiography; magnetic resonance imaging, vascular neck ultrasound imaging.

  3. Rate of acute stroke per participant

    Time frame: From day 0 to 12 weeks

    Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging

  4. Rate of symptomatic central lesion per participant

    Time frame: From day 0 to 12 weeks

    Any central lesion diagnosed by computed tomography or magnetic resonance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance

  5. Rate of specialised consultations for vertigo/dizziness/imbalance per participant

    Time frame: From day 0 to 12 weeks

    Any specialised consultations (neurology, ear nose and throat (ENT), cardiology or similar) to investigate the acute vertigo/dizziness/imbalance with the final diagnosis. Sumarisation of final diagnosis.

  6. Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant

    Time frame: From day 0 to 12 weeks

    Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed.

  7. Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant

    Time frame: From day 0 t0 12 weeks

    Return visit to the emergency department for vertigo/dizziness/imbalance as chief complaint.

  8. Rate of New Atrial Fibrillation

    Time frame: From day 0 to 12 weeks

    Atrial fibrillation detected by the initial visit electrocardiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder).

  9. Rate of New Stroke at 12 weeks

    Time frame: At 12 weeks

    A stroke free status will be assessed by a validated questionnaire by telephone at tree months and all specialised consultations and neuroimaging will be reviewed for acute stroke diagnosis,

  10. Rate of the use of Particles Repositioning Technique

    Time frame: Day 0

    Once Paroxysmal Positional Vertigo diagnosis is being diagnosed with the Dix-Hallpike test or with the Supine Head Roll test, the use of particles repositioning technique, Epley or Gufoni maneuvers, will be noted with their immediate impact on acute vertigo.

  11. Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus

    Time frame: From day 0 to 12 weeks

    Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus: direction, duration

  12. Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance

    Time frame: Day 0

    Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.

  13. Adverse Events

    Time frame: From day 0 to 12 weeks

    Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Randomized Controlled Trial on Nystagmus Assessment for Patients Consulting for Acute Vertigo in the Emergency Department With/Without Frenzel Lens With/Without Form: A Pilot Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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