NCT05176015

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nystagmus, Acquired
• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Frenzel Lens	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_TEST	Diagnostic Algorithm	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

Timeline

• Start date: 2022-01-15
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2022-01-04
• Last updated: 2026-03-18

Locations

5 sites across 1 country: Canada