Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients

Evaluation of Nystagmus Examinations Conducted Using Wearable Augmented Reality Glasses in Vertigo Patients: A Randomized Equivalence Study

Background and Purpose:

Vertigo is common in emergency and outpatient settings, yet standard oculomotor testing usually requires dedicated equipment and exam rooms. This study evaluates whether nystagmus examinations performed with wearable augmented-reality (AR) glasses are equivalent to conventional examination-room testing for classifying central vs. peripheral vertigo. The investigators also assess diagnostic accuracy, patient tolerability, and the reliability of AR-based interpretation (test-retest and inter-rater).

Study Design:

Prospective, single-center, within-subject randomized equivalence study at Kaohsiung Chang Gung Memorial Hospital. Each participant completes both AR-based and conventional oculomotor testing in a randomized order during the same visit, separated by a 30-minute washout. The study uses an evaluator-blind approach: de-identified trajectories are reviewed offline by independent experts who are masked to test modality. A follow-up visit (~1 week) captures adverse events and patient experience.

Participants:

Adults (≥18 years) presenting with vertigo who can tolerate the AR headset and provide consent. Key exclusions include conditions that prevent reliable eye-tracking (e.g., corrected visual acuity <20/40), recent use of vestibular suppressants (within 24 hours), and other factors limiting cooperation or safety.

Interventions and Procedures:

The AR system records eye movements and presents standardized visual stimuli. Conventional testing follows current clinical standards (e.g., Frenzel/oculomotor exam). All recordings are stored securely for blinded review.

Outcomes:

Primary endpoint: Equivalence of diagnostic agreement (central vs. peripheral) between AR-based and conventional methods, quantified by Cohen's kappa (κ) with a predefined equivalence margin.

Secondary endpoints: (1) Diagnostic accuracy of the AR method in a clinically-indicated imaging subgroup (MRI preferred; CT as needed) using a sequential evaluation strategy; (2) Patient discomfort/tolerability using VAS and CSQ-VR, compared between modalities; (3) Test-retest reliability of AR-based classifications; (4) Inter-rater reliability between independent evaluators, with a third reader adjudicating discordant cases; (5) prespecified subgroup analyses by age, medical history, and vestibular function.

Sample Size and Duration:

Approximately 200 participants will be enrolled (target ~180 evaluable after ~10% attrition). Total study duration is ~2 years, including enrollment, follow-up, and analysis.

Risks and Benefits:

Both tests are non-invasive. Potential transient discomfort (e.g., eye strain or cybersickness) will be monitored. There may be no direct benefit to participants; however, results could support broader, more accessible, and standardized vertigo assessment.

Data Security and Privacy:

All data are de-identified, stored on secure platforms with role-based access and audit trails. Safety events are monitored and graded, and protocol deviations are handled per Good Clinical Practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Vertigo; Vestibular Disorder; Nystagmus
• Intervention / Treatment: Device: Wearable Augmented Reality Glasses for Nystagmus Examination; Device: Conventional Nystagmus Examination

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Nung Wu, MD, PhD; Phone Number: +886975369260; Email: taytay@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥18 years with vertigo/dizziness suggestive of a central or peripheral vestibular disorder.
• Able to complete both AR-based and conventional oculomotor testing during the same visit (with ~30-minute washout).
• Provide written informed consent.
• Adequate vision for eye-tracking and calibration (e.g., corrected visual acuity ≥20/40 in each eye).
• Willing and able to return for the follow-up visit.

Exclusion Criteria:

• Use of vestibular-suppressant medications within 24 hours prior to testing (e.g., benzodiazepines, antihistamines, anticholinergics).
• Ocular conditions that would interfere with reliable eye tracking (e.g., corrected visual acuity <20/40, dense cataract, severe ptosis/strabismus, active ocular infection/inflammation).
• History of photosensitive epilepsy or seizure disorder triggered by visual stimuli.
• Severe motion sickness/cybersickness or inability to tolerate the AR headset.
• Significant cognitive impairment or psychiatric condition precluding informed consent or protocol compliance.
• Pregnant or breastfeeding (per investigator judgment and IRB policy).
• Any other condition that, in the investigator's opinion, would make participation unsafe or confound study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR-First Examination Sequence; AR-based examination first, then conventional examination	Device: Wearable Augmented Reality Glasses for Nystagmus Examination; Intervention 1 - Wearable Augmented Reality Glasses for Nystagmus Examination Participants undergo a standardized nystagmus examination using wearable augmented reality (AR) glasses equipped with an integrated eye-tracking system. The AR-based system records real-time eye movements in both light and dark conditions, allowing for simultaneous examiner visualization and data storage. This method eliminates the need for traditional Frenzel goggles and provides automated signal quality assessment.; Device: Conventional Nystagmus Examination; Intervention 2 - Conventional Nystagmus Examination Participants undergo a conventional clinical nystagmus examination performed by an otolaryngologist using standard Frenzel goggles under similar test conditions. Eye movements are visually assessed without integrated digital recording or automated signal analysis.
Active Comparator: Conventional-First Examination Sequence; Conventional examination first, then AR-based examination	Device: Wearable Augmented Reality Glasses for Nystagmus Examination; Intervention 1 - Wearable Augmented Reality Glasses for Nystagmus Examination Participants undergo a standardized nystagmus examination using wearable augmented reality (AR) glasses equipped with an integrated eye-tracking system. The AR-based system records real-time eye movements in both light and dark conditions, allowing for simultaneous examiner visualization and data storage. This method eliminates the need for traditional Frenzel goggles and provides automated signal quality assessment.; Device: Conventional Nystagmus Examination; Intervention 2 - Conventional Nystagmus Examination Participants undergo a conventional clinical nystagmus examination performed by an otolaryngologist using standard Frenzel goggles under similar test conditions. Eye movements are visually assessed without integrated digital recording or automated signal analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence of Diagnostic Agreement (Central vs Peripheral) Between AR-Based and Conventional Examinations, Assessed by Cohen's Kappa	Cohen's Kappa (κ) will be used to evaluate diagnostic agreement between AR-based and conventional examinations. κ ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates chance-level agreement, and negative values indicate worse-than-chance agreement. Higher κ values represent better diagnostic consistency.	Day 1 (immediately after completion of both AR-based and conventional examinations)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of AR-Based Examination Compared to Neuroimaging (Sensitivity, Specificity, PPV, NPV)		Within 30 days after Day 1 (baseline examination), for participants undergoing clinically indicated MRI (preferred) or CT
Test-Retest Reliability of AR-Based Examination (Cohen's Kappa)	Test-retest reliability of AR-based examination will be assessed using Cohen's Kappa coefficient (κ). κ ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates chance-level agreement, and negative values indicate worse-than-chance agreement. Higher κ values indicate better reliability.	Day 1 - within 1 hour after completion of the initial AR-based examination
Patient Discomfort Measured by Visual Analog Scale (VAS)	Visual Analog Scale (VAS) will be used to assess patient-reported discomfort immediately after each test. The VAS ranges from 0 to 10, where 0 indicates no discomfort and 10 indicates the worst imaginable discomfort. Higher scores represent greater discomfort.	Day 1 - immediately after completion of AR-based and conventional examinations
Patient Discomfort Measured by Cybersickness Questionnaire for Virtual Reality (CSQ-VR)	Patient discomfort will also be measured using the Cybersickness Questionnaire for Virtual Reality (CSQ-VR). The CSQ-VR assesses cybersickness symptoms across multiple domains (e.g., nausea, oculomotor strain, disorientation). Scores range from 6 to 42, with higher scores indicating more severe discomfort.	Day 1 - immediately after completion of AR-based and conventional examinations
Inter-Rater Reliability of Diagnostic Interpretations (Cohen's Kappa; Fleiss' Kappa if applicable)	Inter-rater reliability of diagnostic interpretations will be assessed using Cohen's Kappa coefficient (κ) for two raters, and Fleiss' Kappa for three or more raters. Cohen's Kappa (κ): Ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates agreement equivalent to chance, and negative values indicate worse-than-chance agreement. Higher values represent better inter-rater reliability. Fleiss' Kappa: Ranges from -1.0 to 1.0, with the same interpretation as Cohen's Kappa.	Following Day 1 (baseline visit), blinded offline review of examination recordings prior to database lock

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Labyrinth Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vestibular Diseases; Vertigo; Nystagmus, Pathologic
• Other Study ID Numbers: 202500606B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the primary and secondary outcome results will be made available to qualified researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and for up to 5 years thereafter. Requests should be directed to the principal investigator via institutional email and must include a methodologically sound proposal and a signed data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No