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Recruiting NCT07238387

Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients

Conditions: Vertigo, Vestibular Disorder, Nystagmus

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Chang Gung Memorial Hospital

Location: Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan

Summary

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 \

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07238387). StuddyBuddy aggregates publicly available trial information.