An interventional study of Wearable Augmented Reality Glasses for Nystagmus Examination and Conventional Nystagmus Examination in Vertigo, Vestibular Disorder and Nystagmus, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Diagnostic
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.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 138 interventional studies indexed under Vertigo.
Browse Vertigo studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AR-based examination first, then conventional examination
Device: Wearable Augmented Reality Glasses for Nystagmus Examination · Device: Conventional Nystagmus Examination
Conventional examination first, then AR-based examination
Device: Wearable Augmented Reality Glasses for Nystagmus Examination · Device: Conventional 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.
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.
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.
Time frame: Day 1 (immediately after completion of both AR-based and conventional examinations)
Diagnostic Accuracy of AR-Based Examination Compared to Neuroimaging (Sensitivity, Specificity, PPV, NPV)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Following Day 1 (baseline visit), blinded offline review of examination recordings prior to database lock
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 60 non-industry interventional studies with no phase under Vertigo, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 35 months is above that.
Counting every sponsor, half of 64 studies reached it within 19 months; a quarter within 6 and three quarters within 28.
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