[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449725":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":166,"collaborators":168,"id":195,"slug":196,"hasResults":197,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":197,"sex":203,"minAge":204,"maxAge":25,"enrollmentInfo":205,"targetDuration":25,"studyType":208,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"University of Melbourne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","This trial of PSG-assisted commencement of non-invasive ventilation (NIV) in motor neurone disease (MND) follows the methodology of our previous single-site study (Hannan et al 2019 ERJ), with the addition of an open label cohort that extends until (the earlier of) 12 months or death.\n\nAfter empirical NIV set-up and an acclimatisation period (3 weeks), participants will undergo single night in-laboratory polysomnography (PSG). The PSG will be performed and supervised by a sleep scientist. In the intervention group, the \"intervention\" PSG results will be used to adjust\u002Ftitrate NIV settings to optimize ventilation and improve synchrony between the patient and the NIV device. Participants will be asked to continue to use NIV as prescribed for the subsequent 7 week intervention period.",[13],"Other: Intervention polysomnography",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","The participants allocated to the control group will also be asked to attend a single night in-laboratory PSG. The NIV settings will not be adjusted throughout the PSG (\"sham\" PSG). Participants in the control group will retain their original settings after the sham PSG, and will be asked to continue to use NIV in this manner for the subsequent 7 week intervention period.",[19],"Other: Sham polysomnography",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Intervention polysomnography","Please refer to 'Arms: Intervention' section.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham polysomnography","Please refer to 'Arms: Control' section.",[15],[31],{"name":32,"affiliation":5,"role":33},"Abbey Sawyer, PhD","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"David Berlowitz, PhD","CONTACT","+613 9496 3871","david.berlowitz@austin.org.au",[41,56,67,78,90,98,106,113,121,128,139,150,158],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Flinders Medical Centre","NOT_YET_RECRUITING","Adelaide","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],138.59863,-34.92866,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr Vinod Aiyappan",{"facility":57,"status":43,"city":58,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"The Prince Charles Hospital","Brisbane",{"type":48,"coordinates":60},[61,62],153.02809,-27.46794,{"lat":62,"lon":61},[65],{"name":66,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr Deanne Curtin",{"facility":68,"status":43,"city":69,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Motor Neurone Disease Australia","Canberra",{"type":48,"coordinates":71},[72,73],149.12807,-35.28346,{"lat":73,"lon":72},[76],{"name":77,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr Gethin Thomas",{"facility":79,"status":80,"city":81,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Austin Health","RECRUITING","Melbourne",{"type":48,"coordinates":83},[84,85],144.96332,-37.814,{"lat":85,"lon":84},[88],{"name":89,"role":37,"phone":25,"phoneExt":25,"email":25},"Associate Professor Mark Howard",{"facility":91,"status":43,"city":81,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Australian MND Registry",{"type":48,"coordinates":93},[84,85],{"lat":85,"lon":84},[96],{"name":97,"role":37,"phone":25,"phoneExt":25,"email":25},"A\u002FProfessor Paul Talman",{"facility":99,"status":43,"city":81,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"FightMND",{"type":48,"coordinates":101},[84,85],{"lat":85,"lon":84},[104],{"name":105,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr Bec 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Berlowitz",{"facility":129,"status":43,"city":130,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Sir Charles Gairdner Hospital","Perth",{"type":48,"coordinates":132},[133,134],115.8614,-31.95224,{"lat":134,"lon":133},[137],{"name":138,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr Bhajan Singh",{"facility":140,"status":43,"city":141,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Macquarie University","Sydney",{"type":48,"coordinates":143},[144,145],151.20732,-33.86785,{"lat":145,"lon":144},[148],{"name":149,"role":37,"phone":25,"phoneExt":25,"email":25},"Professor Dominic Rowe",{"facility":151,"status":43,"city":141,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Royal Prince Alfred Hospital",{"type":48,"coordinates":153},[144,145],{"lat":145,"lon":144},[156],{"name":157,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr Amanda Piper",{"facility":159,"status":43,"city":141,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"Westmead Hospital",{"type":48,"coordinates":161},[144,145],{"lat":145,"lon":144},[164],{"name":165,"role":37,"phone":25,"phoneExt":25,"email":25},"Dr John Wheatley",{"type":167,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[169,171,173,175,177,180,182,184,185,186,187,188,189,191,193],{"name":170,"class":6},"Austin Hospital, Melbourne Australia",{"name":172,"class":6},"Institute for Breathing and Sleep, Australia",{"name":174,"class":6},"Royal Prince Alfred Hospital, Sydney, Australia",{"name":176,"class":6},"Macquarie University, Australia",{"name":178,"class":179},"Macquarie Health","UNKNOWN",{"name":181,"class":6},"Western Sydney Local Health District",{"name":42,"class":183},"OTHER_GOV",{"name":129,"class":6},{"name":57,"class":183},{"name":114,"class":6},{"name":68,"class":179},{"name":99,"class":6},{"name":190,"class":179},"Australian Motor Neurone Disease Registry",{"name":192,"class":179},"Calvary Bethlehem",{"name":194,"class":6},"Perron Institute for Neurological and Translational Science","100449725","polysomnographic-titration-of-non-invasive-ventilation-in-motor-neurone-disease-100449725",false,"NCT05136222","Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease","A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])","3TLA","Inclusion Criteria:\n\n* Age \\>18 years\n* Clinical indication to commence long term NIV\n* Confirmed clinical diagnosis of underlying condition\n\nExclusion Criteria:\n\n* Medically unstable\n* Hypoventilation attributable to medications with sedative\u002Frespiratory depressant side- effects\n* Use of NIV for more than 1 month in the previous 3 months\n* Inability to provide informed consent\n* Previous intolerance of NIV","ALL","18 Years",{"count":206,"type":207},244,"ESTIMATED","INTERVENTIONAL",[210],"NA","A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.",[213],"Motor Neuron Disease \u002F Amyotrophic Lateral Sclerosis",[215,216,217,218,219],"Non-invasive ventilation","Polysomnography","Sleep study","Amyotrophic lateral sclerosis","Chronic respiratory failure","2022-06-19",{"date":222,"type":223},"2022-06-23","ACTUAL",{"date":225,"type":223},"2021-12-15",{"date":227,"type":207},"2028-02-28",{"name":5,"class":6},13]