Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Equivalence of Diagnostic Agreement (Central vs Peripheral) Between AR-Based and Conventional Examinations, Assessed by Cohen's Kappa [Срок оценки: Day 1 (immediately after completion of both AR-based and conventional examinations)]

Вторичные конечные точки (5)

• Diagnostic Accuracy of AR-Based Examination Compared to Neuroimaging (Sensitivity, Specificity, PPV, NPV) [Срок оценки: 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) [Срок оценки: Day 1 - within 1 hour after completion of the initial AR-based examination]
• Patient Discomfort Measured by Visual Analog Scale (VAS) [Срок оценки: Day 1 - immediately after completion of AR-based and conventional examinations]
• Patient Discomfort Measured by Cybersickness Questionnaire for Virtual Reality (CSQ-VR) [Срок оценки: Day 1 - immediately after completion of AR-based and conventional examinations]
• Inter-Rater Reliability of Diagnostic Interpretations (Cohen's Kappa; Fleiss' Kappa if applicable) [Срок оценки: Following Day 1 (baseline visit), blinded offline review of examination recordings prior to database lock]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Тайвань · 1 центр

• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung

Идентификаторы

NCT: NCT07238387 · 202500606B0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗