[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625246":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":31,"collaborators":20,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":40,"sex":41,"minAge":42,"maxAge":20,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"ResMed","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"APL Mask system tethered overnight study","EXPERIMENTAL","Participants will use APL mask system with a released PAP device for the treatment of OSA.",[13],"Device: Positive Airway Pressure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Positive Airway Pressure","The investigational intervention is the APL mask system, consisting of a nasal mask cushion integrated into a weighted eye mask and headgear. The system is used in a tethered configuration via a released AirFit™ N20 short tube elbow and AirSense™ 11 ClimateLine™ tubing to a commercially available Resmed AirSense™ 11 PAP therapy device.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Xueling Zhu","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Alisha Middleton, BSc (Sport & Exercise Science)","CONTACT","+61422514889","middleton.alisha@hotmail.com",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100625246","evaluation-of-a-wearable-pap-device-in-a-tethered-configuration-for-the-treatment-of-obstructive-sleep-apnoea-100625246",false,"NCT07420140","Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnoea.","Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnea.","Inclusion Criteria: • Participants willing to give written informed consent\n\n* Participants who ≥ 18 years of age\n* Participants who can trial the APL mask system for up to 7 nights\n* Participants willing and able to complete the specified tasks\n* Participants being treated for Obstructive Sleep Apnea (OSA) for ≥ 3 months\\*\n* Participants on APAP therapy\\*\n* Participants currently using a Resmed AirFit N20 Medium mask\\*\n* Participants who are employees of Resmed\\^\n\n  * Only applicable to participants with OSA \\^ Only applicable to internal participants\n\nExclusion Criteria:\n\n* Participants using Bilevel flow generators\n\n  * Participants who are or may be pregnant\n  * Participants with a preexisting 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 (or participants bed partners) with active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin\u002Finfusion pumps).\n  * Participants (or participants bed partners) with metallic implants\u002Fobjects containing ferromagnetic material (i.e., aneurysm clips\u002Fflow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)\n  * Participants who are currently enrolled in other clinical studies\n  * Participants believed to be unsuitable\\* for inclusion by the researcherꝉ",true,"ALL","18 Years",{"count":44,"type":45},15,"ESTIMATED","INTERVENTIONAL",[48],"NA","Each participant will wear a wearable PAP device, tethered to a released PAP device for up to 7 nights. Objectives include collecting and evaluating participants feedback on seal, comfort and usability of the wearable PAP device.",[51],"OSA - Obstructive Sleep Apnea",[53,54],"OSA","CPAP","NOT_YET_RECRUITING","2026-02-12",{"date":58,"type":59},"2026-02-19","ACTUAL",{"date":61,"type":45},"2026-03",{"date":63,"type":45},"2026-06",{"name":5,"class":6}]