[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568519":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":70,"collaborators":12,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":12,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":12,"enrollmentInfo":81,"targetDuration":12,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":12,"overallStatus":51,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,13,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Breathing route assessment: Awake and off pressure support","NO_INTERVENTION","Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Breathing route assessment: Awake and on pressure support","EXPERIMENTAL","Awake participants will be placed on their prescribed pressure support settings and will use two different non-invasive ventilation (NIV) masks, each for about 30 minutes.",[18,19],"Other: NIV mask A","Other: NIV mask B",{"label":21,"type":15,"description":22,"interventionNames":23},"Breathing route assessment: Asleep and on pressure support","Participants will be placed on their prescribed pressure support settings and will go to sleep. After 60 minutes, they will be awakened to change their mask. They will use two different non-invasive ventilation (NIV) masks, each for a minimum of 60 minutes",[18,19],[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":12},"OTHER","NIV mask A","Bridge free face mask",[21,14],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":12},"NIV mask B","Full face mask",[21,14],[35],{"name":36,"affiliation":37,"role":38},"William Good, Medical degree","Middlemore Hospital, New Zealand","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":12,"email":44},"Valeria Mereacre, PhD Physiology","CONTACT","0064 2102819036","val.mereacre@fphcare.co.nz",{"name":46,"role":42,"phone":12,"phoneExt":12,"email":47},"Jessica Fogarin","jess.fogarin@fphcare.co.nz",[49],{"facility":50,"status":51,"city":52,"state":12,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Fisher and Paykel Healthcare Sleep Laboratory","RECRUITING","Auckland","2013","New Zealand","NZ",{"type":57,"coordinates":58},"Point",[59,60],174.76349,-36.84853,{"lat":60,"lon":59},[63,65,68],{"name":46,"role":42,"phone":64,"phoneExt":12,"email":47},"7327",{"name":66,"role":67,"phone":12,"phoneExt":12,"email":12},"Valeria Mereacre","SUB_INVESTIGATOR",{"name":69,"role":38,"phone":12,"phoneExt":12,"email":12},"William R Good, Medical degree",{"type":71,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100568519","assessment-of-breathing-pattern-during-niv-100568519",false,"NCT06682286","Assessment of Breathing Pattern During NIV","Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study","Inclusion Criteria:\n\n* Age over 18 years\n* Prescribed nocturnal NIV for COPD or OHS\n* Able to complete an overnight sleep study\n* Comfortable to sleep on a standard double bed\n* Capacity to complete informed consent\n\nExclusion Criteria:\n\n* Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events\u002Fhour off personal NIV device data)\n* Prescribed IPAP above 25 cmH2O\n* Self-reported pregnancy\n* Allergic to adhesive of the sensors\n* Self-reported cold\u002Fflu symptoms","ALL","18 Years",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"NA","COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. The type of mask used for breathing support can greatly affect a patient's comfort and willingness to use it. For conditions like Obstructive Sleep Apnea (OSA), which is a physical blockage of the airway caused by the relaxation of the muscles of the throat, nasal masks are often used because they are comfortable and work well. But for breathing support in the hospital, full face masks are typically used because patients are having significant trouble breathing and tend to breathe through their mouth.\n\nHowever, it's important to note that we don't yet fully understand the best way to provide breathing support for long-term NIV users, like COPD and OHS patients. The understanding of breathing route is currently only established for OSA. However, conditions like COPD affect the lungs and the overall system used for breathing, which is different from the throat blockage seen in OSA. So, the assumptions we make based on conditions like OSA may not apply to these other conditions. More research is needed to understand this better.",[89,90],"COPD (Chronic Obstructive Pulmonary Disease)","Obesity Hypoventilation Syndrome (OHS)","2025-05-07",{"date":93,"type":94},"2025-05-11","ACTUAL",{"date":96,"type":94},"2025-01-24",{"date":98,"type":83},"2025-09",{"name":5,"class":6},1]