[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476291":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":29,"id":55,"slug":29,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":29,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":29,"enrollmentInfo":62,"targetDuration":29,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":29,"overallStatus":39,"whyStopped":29,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Loewenstein Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"speaking valve","EXPERIMENTAL","Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).",[13],"Device: Shiley™ phonate speaking valve",{"label":15,"type":6,"description":16,"interventionNames":17},"control","Respiratory physical therapy treatments conducted without using a speaking valve .",[18],"Other: control",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Shiley™ phonate speaking valve","The device connects to the tracheostomy tube. Usually used to aid vocalization.",[9],[9],{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"no intervention",[15],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Elena Aidinoff, MD","CONTACT","972-9-7654897","aidinofe@clalit.org.il",[37],{"facility":38,"status":39,"city":40,"state":29,"zip":29,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Loewenstein Rehabilitation Hospital","RECRUITING","Raanana","Israel",{"type":43,"coordinates":44},"Point",[45,46],34.87386,32.1836,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":29,"phoneExt":29,"email":29},"Sara Lipkin",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","elena eidinov","Head of Intensive Care for Consciousness Rehabilitation Department","100476291",false,"NCT05482022","Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.","Inclusion Criteria:\n\n* brain injury (traumatic\u002Fnon-traumatic).\n* tracheostomy.\n* unresponsive wakefulness syndrome or minimally conscious state.\n* fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.\n* the legal guardian speaks Hebrew.\n\nExclusion Criteria:\n\n* airway stenosis \u002F inflammation.\n* oxygen saturation \\\u003C90%.","ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.\n\nThe investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.",[70],"Tracheostomy","2025-08-10",{"date":73,"type":74},"2025-08-14","ACTUAL",{"date":76,"type":74},"2022-08-01",{"date":78,"type":64},"2026-01-15",{"name":5,"class":6},1]