Testing Nystagmus in Adults With Vertigo Using Wearable Augmented Reality Glasses Compared to Standard Exams A Randomized Study

What this Trial Is About

Researchers are evaluating the use of wearable augmented reality AR glasses for nystagmus examination in adults experiencing vertigo. This study compares the AR-based eye movement tests to conventional examination-room methods to determine if both approaches provide equivalent results in distinguishing central versus peripheral vertigo. The study also investigates diagnostic accuracy, patient comfort, and the reliability of AR-based interpretations. It is a prospective, randomized equivalence trial conducted at a single center using a crossover design with evaluator blinding. Participants undergo both AR-based and conventional nystagmus examinations during the same visit in a randomized order, separated by a 30-minute washout period. The AR glasses record eye movements with integrated eye tracking and provide real-time visualization and data storage, replacing traditional Frenzel goggles. Conventional testing uses standard Frenzel goggles without digital recording. A follow-up visit about one week later gathers information on adverse events and patient experience. During the study, participants complete both tests and provide feedback on discomfort through questionnaires. Independent experts review de-identified eye movement recordings without knowledge of the test type to assess diagnostic agreement and reliability. The primary outcome is the equivalence of diagnostic classification between methods. Secondary outcomes include diagnostic accuracy compared to neuroimaging, test-retest and inter-rater reliability, and patient tolerability. Safety is monitored throughout, and data are securely stored with privacy safeguards. The study aims to enroll about 200 adults over approximately two years.

Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients