[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628598":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":46,"centralContacts":51,"locations":45,"responsibleParty":58,"collaborators":45,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":45,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":45,"enrollmentInfo":70,"targetDuration":45,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":45,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":45},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,14,17,22,25,29,32,36],{"label":9,"type":10,"description":11,"interventionNames":12},"NIV using Mask A, with mouth-open","EXPERIMENTAL","Mask A is the investigational mask",[13],"Device: Non-invasive ventilation (NIV)",{"label":15,"type":10,"description":11,"interventionNames":16},"NIV using Mask A, with mouth-closed",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"NIV using Mask B, with mouth-open","ACTIVE_COMPARATOR","Mask B is a comparator mask",[13],{"label":23,"type":19,"description":20,"interventionNames":24},"NIV using Mask B, with mouth-closed",[13],{"label":26,"type":19,"description":27,"interventionNames":28},"NIV using Mask C, with mouth-open","Mask C is a comparator mask",[13],{"label":30,"type":19,"description":27,"interventionNames":31},"NIV using Mask C, with mouth-closed",[13],{"label":33,"type":19,"description":34,"interventionNames":35},"NIV using Mask D, with mouth-open","Mask D is a comparator mask",[13],{"label":37,"type":19,"description":34,"interventionNames":38},"NIV using Mask D, with mouth-closed",[13],[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DEVICE","Non-invasive ventilation (NIV)","Delivery of positive airway pressure to the lungs via an interface, such as a mask",[15,9,23,18,30,26,37,33],null,[47],{"name":48,"affiliation":49,"role":50},"William Good, Medical degree","Middlemore Hospital, New Zealand","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Olivia Kennington","CONTACT","+64(09)5740100","5425","olivia.kennington@fphcare.co.nz",{"type":59,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100628598","the-effect-of-home-and-hospital-mask-designs-on-respiratory-variables-in-healthy-volunteers-100628598",false,"NCT07463716","The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers","The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers: A Pilot Clinical Investigation","Inclusion Criteria:\n\n* Aged 18 years or over\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Unable to tolerate non-invasive ventilation (NIV)\n* Unable to adequately fit an NIV mask\n* Claustrophobia while using NIV\n* Symptoms of cold or flu (including COVID-19) in previous twenty-four hours\n* Chronic Rhinitis or self-reported history of upper airway obstruction\n* Pneumothorax or history of previous pneumothorax\n* Employee in the NIV team at Fisher \\& Paykel Healthcare",true,"ALL","18 Years",{"count":71,"type":72},10,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are:\n\n* To assess if mask design impacts the ventilatory ratio in healthy volunteers.\n* To assess if mask design impacts transcutaneous CO2, respiratory rate, and tidal volume in healthy volunteers.\n\nParticipants will attend five study visits:\n\n* Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.\n* Visit 2. Participants will receive NIV with one of four masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.\n* Visits 3-5. Participants will receive NIV with one of the other three masks, repeating Visit 2.",[78],"Healthy Volunteers",[80,81],"Noninvasive ventilation","Pulmonary","NOT_YET_RECRUITING","2026-03-05",{"date":85,"type":86},"2026-03-11","ACTUAL",{"date":88,"type":72},"2026-03",{"date":90,"type":72},"2026-06",{"name":5,"class":6}]