[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377804":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":49,"collaborators":10,"id":52,"slug":10,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"University of Oslo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Persons who cannot communicate unequivocally",null,"Persons with intellectual disability, childhood autism, and\u002For cerebral palsy who cannot communicate unequivocally and therefore cannot communicate their needs and wishes, e.g. whether they are uncomfortable, in pain, scared, angry, happy, pleased.",[13],"Device: Heart rate and respiration rate sensors",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Heart rate and respiration rate sensors","The use of sensors to monitor physiological variables (e.g. heart rate, sleep). The design is a before-and-after comparison with respect to whether the use of sensors has changed the caregivers' practice and their (perceived) understanding of the participant. The frequency of participants' self harm or aggressive behavior after as compared to before the introduction of pulse- and respiration monitors will also be charted.",[9],[21],{"name":22,"affiliation":5,"role":23},"Bjørnar Hassel, PhD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","004798829754","bjornar.hassel@medisin.uio.no",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Emilie SM Kildal","004745481949","eskildal@sv.uio.no",[34],{"facility":5,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Oslo","0450","Norway","NO",{"type":41,"coordinates":42},"Point",[43,44],10.74609,59.91273,{"lat":44,"lon":43},[47,48],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},{"type":23,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Bjørnar Hassel","Professor, Senior consultant","100377804",false,"NCT04199299","Sensors for Communication for Persons Who Cannot Communicate Unequivocally","The Use of Sensors to Improve Communication for Persons With Intellectual Disability Who Cannot Communicate Unequivocally","Inclusion Criteria:\n\n* intellectual disability with or without autism and\u002For cerebral palsy that render the participant unable to communicate his\u002Fher needs and reactions unequivocally.\n\nExclusion Criteria:\n\n* allergic skin reaction to chest strap","ALL","5 Years","80 Years",{"count":62,"type":63},100,"ESTIMATED","OBSERVATIONAL","Some persons with intellectual disability or comprehensive cerebral palsy cannot communicate unequivocally how they are, how they react to situations and people, whether they are in pain or experience discomfort, anger or fear. Their modes of communication (sounds, grimacing etc) may be unintelligible or ambiguous to their caregivers.\n\nWith the use of heart and\u002For respiration monitors the investigators aim to give these persons a means to communicate their immediate reactions or responses. The respiration monitor is meant to register sleep at night, so that the participants can communicate whether they have slept well or not the previous night.",[67,68,69],"Intellectual Disability","Autism","Cerebral Palsy","2025-07-01",{"date":72,"type":73},"2025-07-04","ACTUAL",{"date":75,"type":73},"2020-02-01",{"date":77,"type":63},"2032-12-31",{"name":5,"class":6},1]