Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Vertigo; Nystagmus; Vestibular Disorder

Treatments: Device: Wearable Augmented Reality Glasses for Nystagmus Examination; Device: Conventional Nystagmus Examination

Study type: Interventional

Funder types: Other

Identifiers

NCT07238387

202500606B0

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

AR-First Examination Sequence

Experimental group

Description:

AR-based examination first, then conventional examination

Treatment:

Device: Conventional Nystagmus Examination

Device: Wearable Augmented Reality Glasses for Nystagmus Examination

Conventional-First Examination Sequence

Active Comparator group

Description:

Conventional examination first, then AR-based examination

Treatment:

Device: Conventional Nystagmus Examination

Device: Wearable Augmented Reality Glasses for Nystagmus Examination