[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100318432":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":52,"centralContacts":57,"locations":62,"responsibleParty":79,"collaborators":45,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":45,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":45,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":65,"whyStopped":45,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Lund University","OTHER",[8,14,19,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo medication and sham stimulation","ACTIVE_COMPARATOR","Patients will be randomly chosen to the group who will get a combination of placebo and sham stimulation.",[13],"Device: Sham stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Active medication","Patients are randomly chosen to the group who will get active medication without stimulation.",[18],"Drug: Active medication",{"label":20,"type":21,"description":22,"interventionNames":23},"Active stimulation","SHAM_COMPARATOR","Patients are randomly chosen to the group who will get acitive stimulation without taking medicine.",[24],"Device: Stochastic Vestibular Stimulation",{"label":26,"type":10,"description":27,"interventionNames":28},"Controls with sham stimulation","Controls without ADHD are randomly chosen to the group who will get sham stimulation.",[13],{"label":30,"type":21,"description":31,"interventionNames":32},"Controls with active stimulation","Controls without ADHD are randomly chosen to the group who will get active stimulation.",[24],[34,41,46],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DEVICE","Stochastic Vestibular Stimulation","Stochastic vestibular stimulation will be given by electric stimulation through electrodes place over the mastoid processes behind each ear. Auditory stimulation with stochastic white noise will be administrated through ear phones.",[20,30],[40],"Auditory white noise stimulation",{"type":35,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Sham stimulation","Patients will receive sham stimulation in place of active vestibular stimulation.",[26,9],null,{"type":47,"name":15,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Patients will be examined with and without medication.",[15],[51],"Concerta, Ritalin, Methylphenidate, Equasym or Medikinet",[53],{"name":54,"affiliation":55,"role":56},"Peik Gustafsson, MD, PhD","Department of clinical sciences, Lund Uniersity","PRINCIPAL_INVESTIGATOR",[58],{"name":54,"role":59,"phone":60,"phoneExt":45,"email":61},"CONTACT","+46736250674","Peik.Gustafsson@med.lu.se",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University","RECRUITING","Lund","Skåne County","221 85","Sweden","SE",{"type":72,"coordinates":73},"Point",[74,75],13.19321,55.70584,{"lat":75,"lon":74},[78],{"name":54,"role":59,"phone":60,"phoneExt":45,"email":61},{"type":80,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100318432","acoustic-and-vestibular-noise-as-possible-non-pharmacological-treatment-of-adhd-in-school-children-100318432",false,"NCT03425669","Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children","Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children","Inclusion Criteria: Children and adolescents with a diagnosis of ADHD and control children without at diagnosis.\n\n\\-\n\nExclusion Criteria: Intellectual disability, psychosis, severe depression or anxiety\n\n\\-",true,"ALL","9 Years","18 Years",{"count":93,"type":94},70,"ESTIMATED","INTERVENTIONAL",[97],"NA","Noise benefit in ADHD Auditory noise benefit: The original findings from our research group, that auditory noise enhances cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis, have been replicated several times (Baijot et al., 2016; Söderlund et al., 2016; Söderlund \\& Nilsson Jobs, 2016; Söderlund et al., 2007). In a new study, the benefit of noise was shown to be in parity with or even larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic word recall and visuo-spatial working memory task. In the study a group of children diagnosed with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent environments while performing the tasks (Söderlund, Björk et al., 2016).\n\nParticipants and recruitment: Participants with an ADHD diagnosis using medication will be recruited from Child and Adolescent Psychiatry in Lund and Malmö. Typically developing children (TDC) and inattentive children without diagnosis will be recruited from schools in collaboration with the municipality.\n\nExperimental design: All participants will perform a double-blind placebo cross over control study. ADHD participants will perform the entire test battery at three occasions with 2-3 weeks intermission in between tests. One occasion with placebo medication and sham SVS stimulation; one occasion with active SVS stimulation; and one occasion with active medication. TD children will only be tested twice while they will not be given any medication or placebo and just perform under SVS vs. sham conditions.\n\nTest battery: 1) Episodic memory will be tested trough Auditory Verbal Learning Test (AVLT) (e.g. Dige et al., 2008). 2) Visuo-spatial working memory will be tested through the Spanboard task (Westerberg et al., 2004). 3) Motor-neurological investigation. 4) A finger tapping task. 5) Evaluation of an iPhone auditory noise application in a normal school setting. Our research group has developed an iPhone application (www.smartnoise.se) that is available at App-store right now. The study will last for about 5 months and participants will be 50 voluntary secondary school pupils that have documented attention difficulties as judged by their teachers. The application will be evaluated both by pupils, teachers and parents.",[100],"ADHD",[102],"Acoustic and vestibular noise stimulation","2023-10-10",{"date":105,"type":106},"2023-10-11","ACTUAL",{"date":108,"type":106},"2019-05-01",{"date":110,"type":94},"2027-05-31",{"name":5,"class":6},1]