Nystagmus, AcquiredNCT05176015
Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo
A study testing Frenzel Lens and Diagnostic Algorithm in people with Nystagmus, Acquired and Stroke, Acute, run by CHU de Quebec-Universite Laval at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nystagmus, Acquired, Stroke, Acute
- What is being tested?
- Frenzel Lens and Diagnostic Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Jan 2022to 10 Feb 2025
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days
- Must be able to consent.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Centre Hospitalier d'Amqui
Amqui, Quebec, G5J 2K5
Centre Hospitalier de Matane
Matane, Quebec, G4W 2W5
Centre Hospitalier de Montmagny
Saint Thomas de Montmagny, Quebec, G5V 3R8
Hopital St-Georges
Saint-Georges, Quebec, G5Y4T8
Hopital Notre-Dame-de-Fatima
Ste. Anne de la Pocatière, Quebec, G0R 1Z0
About this study
Official 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
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.
Read the 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
- Being tested
- Frenzel Lens, Diagnostic Algorithm
- Keywords
- nystagmus, stroke, neuroimaging, cardiovascular disease, benign positional paroxystic vertigo
- Medical subject headings
- Nystagmus, Pathologic, Stroke, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frenzel LensDevice
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 AlgorithmDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Frenzel Lens with Diagnostic Algorithm | Experimental | Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and if present describe its main characteristic.
Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging Receives: Device: Frenzel Lens; Diagnostic Test: Diagnostic Algorithm |
| Frenzel Lens without Diagnostic Algorithm | Experimental | Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and describe its main characteristics. No diagnostic algorithm will be used to interpret nystagmus. Receives: Device: Frenzel Lens |
| No Frenzel Lens with Diagnostic Algorithm | Experimental | Nystagmus assessment in different manoeuvres is performed without the use of Frenzel lens.
Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging Receives: Diagnostic Test: Diagnostic Algorithm |
| No Frenzel Lens and No Diagnostic Algorithm | No intervention | The emergency physician is performing the assessment of nystagmus and its interpretation as usual. The Frenzel lens and the diagnostic algorithm are not used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Nystagmus detection per participant
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)
Measured: Day 0
Secondary outcomes (13)
Emergency Department Length of stay
Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours
Measured: Day 0, from triage time to Emergency Department departure (admission or home discharge)
Rate of neuro-imaging per participant
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.
Measured: From day 0 to 12 weeks
Rate of acute stroke per participant
Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging
Measured: From day 0 to 12 weeks
Rate of symptomatic central lesion per participant
Any central lesion diagnosed by computed tomography or magnetic resonance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance
Measured: From day 0 to 12 weeks
Rate of specialised consultations for vertigo/dizziness/imbalance per participant
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.
Measured: From day 0 to 12 weeks
Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant
Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed.
Measured: From day 0 to 12 weeks
Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant
Return visit to the emergency department for vertigo/dizziness/imbalance as chief complaint.
Measured: From day 0 t0 12 weeks
Rate of New Atrial Fibrillation
Atrial fibrillation detected by the initial visit electrocardiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder).
Measured: From day 0 to 12 weeks
Rate of New Stroke 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,
Measured: At 12 weeks
Rate of the use of Particles Repositioning Technique
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.
Measured: Day 0
Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus
Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus: direction, duration
Measured: From day 0 to 12 weeks
Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance
Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.
Measured: Day 0
Adverse Events
Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy
Measured: From day 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start15 Jan 2022
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nystagmus, AcquiredStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre La Rochelle, CHU de Quebec-Universite Laval
- Investigators
- Pierre La Rochelle, MD, MSc, Principal investigator, Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176015
- Sponsor's protocol ID
- MP-CIBSSSBSL-2021-03
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05176015
- Acronym / sponsor ID
- MP-CIBSSSBSL-2021-03
- Conditions
- Nystagmus, Acquired, Stroke, Acute
- Keywords
- nystagmus, stroke, neuroimaging, cardiovascular disease, benign positional paroxystic vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 4 Jan 2022 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Frenzel Lens with Diagnostic Algorithm | Experimental | Device: Frenzel Lens, Diagnostic Test: Diagnostic AlgorithmFrenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and if present describe its main characteristic. Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging |
| Frenzel Lens without Diagnostic Algorithm | Experimental | Device: Frenzel LensFrenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and describe its main characteristics. No diagnostic algorithm will be used to interpret nystagmus. |
| No Frenzel Lens with Diagnostic Algorithm | Experimental | Diagnostic Test: Diagnostic AlgorithmNystagmus assessment in different manoeuvres is performed without the use of Frenzel lens. Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging |
| No Frenzel Lens and No Diagnostic Algorithm | No intervention | –The emergency physician is performing the assessment of nystagmus and its interpretation as usual. The Frenzel lens and the diagnostic algorithm are not used. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days
- Must be able to consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frenzel Lenspair 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. | Device | Frenzel Lens with Diagnostic Algorithm, Frenzel Lens without Diagnostic Algorithm |
| Diagnostic AlgorithmA 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 | Diagnostic test | Frenzel Lens with Diagnostic Algorithm, No Frenzel Lens with Diagnostic Algorithm |
Primary outcome
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)
13 secondary outcomes
Emergency Department Length of stay
Time frame: Day 0, from triage time to Emergency Department departure (admission or home discharge)
Rate of neuro-imaging per participant
Time frame: From day 0 to 12 weeks
Rate of acute stroke per participant
Time frame: From day 0 to 12 weeks
Rate of symptomatic central lesion per participant
Time frame: From day 0 to 12 weeks
Rate of specialised consultations for vertigo/dizziness/imbalance per participant
Time frame: From day 0 to 12 weeks
Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant
Time frame: From day 0 to 12 weeks
Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant
Time frame: From day 0 t0 12 weeks
Rate of New Atrial Fibrillation
Time frame: From day 0 to 12 weeks
Rate of New Stroke at 12 weeks
Time frame: At 12 weeks
Rate of the use of Particles Repositioning Technique
Time frame: Day 0
Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus
Time frame: From day 0 to 12 weeks
Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance
Time frame: Day 0
Adverse Events
Time frame: From day 0 to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Pierre La Rochelle, MD, MSc principal investigator
Universite Laval
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frenzel Lens and Diagnostic Algorithm in people with Nystagmus, Acquired and Stroke, Acute, run by CHU de Quebec-Universite Laval at 5 sites in Canada.
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 2 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Nystagmus detection per participant (time frame: Day 0). 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 18 Mar 2026.