[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Onovis Augenpraxis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100603418","a-quick-and-reliable-eye-movement-test-to-help-diagnose-adhd-in-children-100603418",false,"NCT07136259","A Quick and Reliable Eye Movement Test to Help Diagnose ADHD in Children.","Certified Comprehensive Eye-Movement Examination in Children With Attention Deficit Hyperactivity Disorder: An Objective, Reproducible and Quantitative Diagnosis in 15 Minutes?","ADHDin15?","Inclusion criteria:\n\nFor the ADHD group:\n\n* Clinically confirmed diagnosis of ADHD by an expert (e.g., pediatrician, neuropsychologist, pediatric neurologist)\n* Age between 8 and 16 years\n* Written informed consent from the participant and\u002For legal guardian\n\nFor the control group (non-ADHD):\n\n* Age between 8 and 16 years\n* No suspicion of ADHD\n* Written informed consent from the participant and\u002For legal guardian\n\nExclusion Criteria:\n\nFor both groups:\n\n* Medical conditions known to affect ocular motor behavior (e.g., neurological or ophthalmological disorders)\n* Doubts regarding the accuracy of the ADHD diagnosis (for the ADHD group)\n* Lack of or questionable informed consent\n* Suspicion of ADHD in control group participants (reported by parents, examiner, or physician)",true,"ALL","8 Years","16 Years",{"count":22,"type":23},100,"ESTIMATED","OBSERVATIONAL","Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Early and accurate diagnosis is crucial to ensure timely therapeutic and educational interventions. However, current diagnostic practices rely heavily on clinical interviews and behavioral observations, which are inherently subjective and resource-intensive.\n\nThere is a growing need for objective diagnostic tools that can complement or even partially replace current clinical assessments. One promising approach involves eye-tracking technology, as ADHD is associated with altered oculomotor control and attention-related neural circuits. These changes may be reflected in measurable eye movement parameters, including saccadic latency and fixation stability.\n\nThis clinical investigation uses a certified, CE-marked medical eye-tracking device (neos™) to assess whether specific eye movement parameters can serve as objective biomarkers for ADHD. Although the device was originally designed to assess visual pathway integrity, it also captures parameters related to attention and executive function through standardized protocols. The test is examiner-independent, non-invasive, and takes approximately 10 minutes.\n\nThe study is observational and non-interventional, involving two groups of participants aged 8 to 16: 50 children with a clinically confirmed diagnosis of ADHD and 50 age-matched non-ADHD controls. All participants will complete a single neos™ eye-tracking assessment.\n\nThe primary hypothesis is that children with ADHD will demonstrate greater variability in saccadic latency and a higher frequency of large saccades (\\> 3°) during fixation compared to controls. These differences will be analyzed as potential diagnostic biomarkers. Diagnostic accuracy will be evaluated using receiver operating characteristic (ROC) analysis, with sensitivity, specificity and area under the curve (AUC) values reported.\n\nSecondary hypotheses include:\n\nOculomotor parameters derived from the neos™ system can distinguish between ADHD subtypes (predominantly inattentive, hyperactive-impulsive and combined).\n\nCombined oculomotor metrics correlate with ADHD symptom severity, potentially enabling a quantitative assessment of disease burden.\n\nThe results of this study could pave the way for the clinical adoption of objective, scalable and rapid diagnostic tools for ADHD. Beyond clinical use, such tools may also be adapted for population screening, telemedicine or integration into consumer-grade technologies such as virtual reality headsets. By validating a market-approved device for a new mental health indication, this study represents a critical step toward bridging research and clinical application in ADHD diagnostics.",[27,28],"Attention Deficit Disorder With Hyperactivity (ADHD)","Attention Deficit Disorder (ADD)",[30,31,32,33,34,35,36,37,38],"ADHD","Eye Tracking","Oculomotor Function","Pupillary Response","Pedriatic Neuropsychiatry","Neurodevelopmental Disorders","Neurocognitive Testing","Non-invasive Assessment","Eye Movements","NOT_YET_RECRUITING","2025-08-14",{"date":42,"type":43},"2025-08-22","ACTUAL",{"date":45,"type":23},"2025-09-01",{"date":47,"type":23},"2026-01-31",{"name":49,"class":50},"Onovis Augenpraxis","NETWORK",""]