[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nystagmus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nystagmus":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100611269",false,"NCT07238387","Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients","Evaluation of Nystagmus Examinations Conducted Using Wearable Augmented Reality Glasses in Vertigo Patients: A Randomized Equivalence Study","Inclusion Criteria:\n\n* Adults ≥18 years with vertigo\u002Fdizziness suggestive of a central or peripheral vestibular disorder.\n* Able to complete both AR-based and conventional oculomotor testing during the same visit (with \\~30-minute washout).\n* Provide written informed consent.\n* Adequate vision for eye-tracking and calibration (e.g., corrected visual acuity ≥20\u002F40 in each eye).\n* Willing and able to return for the follow-up visit.\n\nExclusion Criteria:\n\n* Use of vestibular-suppressant medications within 24 hours prior to testing (e.g., benzodiazepines, antihistamines, anticholinergics).\n* Ocular conditions that would interfere with reliable eye tracking (e.g., corrected visual acuity \\\u003C20\u002F40, dense cataract, severe ptosis\u002Fstrabismus, active ocular infection\u002Finflammation).\n* History of photosensitive epilepsy or seizure disorder triggered by visual stimuli.\n* Severe motion sickness\u002Fcybersickness or inability to tolerate the AR headset.\n* Significant cognitive impairment or psychiatric condition precluding informed consent or protocol compliance.\n* Pregnant or breastfeeding (per investigator judgment and IRB policy).\n* Any other condition that, in the investigator's opinion, would make participation unsafe or confound study results.","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22],"NA","Background and Purpose:\n\nVertigo 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).\n\nStudy Design:\n\nProspective, 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.\n\nParticipants:\n\nAdults (≥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 \\\u003C20\u002F40), recent use of vestibular suppressants (within 24 hours), and other factors limiting cooperation or safety.\n\nInterventions and Procedures:\n\nThe AR system records eye movements and presents standardized visual stimuli. Conventional testing follows current clinical standards (e.g., Frenzel\u002Foculomotor exam). All recordings are stored securely for blinded review.\n\nOutcomes:\n\nPrimary 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.\n\nSecondary 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\u002Ftolerability 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.\n\nSample Size and Duration:\n\nApproximately 200 participants will be enrolled (target \\~180 evaluable after \\~10% attrition). Total study duration is \\~2 years, including enrollment, follow-up, and analysis.\n\nRisks and Benefits:\n\nBoth 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.\n\nData Security and Privacy:\n\nAll 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.",[25,26,27],"Vertigo","Vestibular Disorder","Nystagmus","NOT_YET_RECRUITING","2025-11-18",{"date":31,"type":32},"2025-11-20","ACTUAL",{"date":34,"type":19},"2026-01-01",{"date":36,"type":19},"2029-12-31",{"name":38,"class":39},"Chang Gung Memorial Hospital","OTHER",""]