[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459424":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":53,"collaborators":19,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":19,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":19,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"ResMed","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"New generation CPAP mask","EXPERIMENTAL","The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released.",[13],"Device: New generation CPAP mask",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","All participants entered into the study will be couriered a new generation ResMed mask system to be used with their own CPAP machine and in place of their own mask.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jeff Armistead, PhD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Xueling Zhu, BHSc (Nursing), RN","CONTACT","02 8884 2265","Xueling.Zhu@resmed.com.au",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Ross Deas, PhD","02 8884 1703","ross.deas@resmed.com.au",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Medical Affairs ResMed","RECRUITING","Sydney","New South Wales","2153","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],151.20732,-33.86785,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":52,"phoneExt":19,"email":19},"Jeff Armitstead, PhD","61488840000",{"type":54,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100459424","post-market-clinical-follow-up-of-resmed-mask-systems-100459424",false,"NCT05262439","Post Market Clinical Follow up of ResMed Mask Systems","Inclusion Criteria:\n\n* Participants willing to give written informed consent\n* Participants who can read and comprehend English\n* Participants who ≥ 18 years of age\n* Participants being treated for OSA for ≥ 6 months\n* Participants currently using a suitable mask system\n* Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards\n\nExclusion Criteria:\n\n* Participants using Bilevel flow generators\n* Participants who are or may be pregnant\n* Participants with a pre-existing lung disease\u002F condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\\\u003C 2years) case of pneumonia or lung infection; lung injury.\n* Participants believed to be unsuitable for inclusion by the researcher\n* Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)","ALL","18 Years","100 Years",{"count":65,"type":66},500,"ESTIMATED","INTERVENTIONAL",[69],"NA","Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .",[72],"Obstructive Sleep Apnea","2026-04-23",{"date":75,"type":76},"2026-04-29","ACTUAL",{"date":78,"type":76},"2022-05-26",{"date":80,"type":66},"2027-06",{"name":5,"class":6},1]