[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533739":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":77,"collaborators":10,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Gødstrup Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy children without hearing or balance problems",null,"Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.",[13,14,15,16,17],"Diagnostic Test: video Head Impulse Test","Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential","Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential","Diagnostic Test: Computerized Dynamic Posturography","Other: Dizziness Handicap Inventory for patient caregivers",[19,26,32,38,44],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","video Head Impulse Test","For v-HIT, the Synapsys v-HIT Ulmer device is used.",[9],[25],"vHIT",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Cervical Vestibular Evoked Myogenic Potential","For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.",[9],[31],"cVEMP",{"type":20,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Ocular Vestibular Evoked Myogenic Potential","For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.",[9],[37],"oVEMP",{"type":20,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Computerized Dynamic Posturography","To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used.",[9],[43],"CDP",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Dizziness Handicap Inventory for patient caregivers","DHI is a caregiver-reported 21-item questionnaire. It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap. Scores under 16 are characterized as no limitation or handicap. A score from 16-26 present a mild perceived handicap and mild limitations. A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations.",[9],[49],"DHI-PC",[51],{"name":52,"affiliation":53,"role":54},"Therese Ovesen, Professor","University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK","STUDY_CHAIR",[56],{"name":57,"role":58,"phone":59,"phoneExt":10,"email":60},"Signe F Bønløkke, PhD student","CONTACT","+4541405064","siband@rm.dk",[62],{"facility":63,"status":64,"city":65,"state":10,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Gødstrup Regional Hospital","RECRUITING","Herning","7400","Denmark","DK",{"type":70,"coordinates":71},"Point",[72,73],8.97662,56.13615,{"lat":73,"lon":72},[76],{"name":57,"role":58,"phone":10,"phoneExt":10,"email":60},{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Signe Fiil Bønløkke","Principal Investigator","100533739","normative-data-of-vestibular-and-postural-function-in-danish-children-100533739",false,"NCT06229730","Normative Data of Vestibular and Postural Function in Danish Children","Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)","VASIC","Inclusion Criteria:\n\n* Children in the age of 6 months -10 years\n* Normal hearing\n* No history of dizziness or balance problems\n* Written informed consent from the parents.\n\nExclusion Criteria:\n\n* Premature birth\n* Existing or previous inner ear disease(s) or previous inner ear surgery\n* Cholesteatoma or previous middle ear surgery\n* Known or previous vestibular disorder (Vestibular schwannoma, Mb Meniere, vestibular neuritis or other known)\n* Delayed gross motor development evaluated through milestones.\n* Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.\n* Congenital nystagmus\n* Compromised eye muscle mobility\n* A diagnose of any neurological disease.\n* A diagnose of any psychiatric disease.\n* VEMP-electrode allergy\n* History of symptomatic head or neck trauma\n* Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)",true,"ALL","6 Months","10 Years",{"count":94,"type":95},90,"ESTIMATED","OBSERVATIONAL","The goal of this age-based cohort study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics. The participants will be children in the age of 6 months to 10 years, without any known hearing or balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.",[99,100],"Children, Only","Vestibular Function",[102,103,104,105,106,21,107,39,108],"Vestibular dysfunction","Balance problem","Children","Dizziness","Vestibular assessment","Vestibular Evoked Myogenic Potential","Quality of life","2025-08-21",{"date":111,"type":112},"2025-08-26","ACTUAL",{"date":114,"type":112},"2025-06-01",{"date":116,"type":95},"2027-12",{"name":5,"class":6},1]