[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590835":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":82,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Noninvasive ventilation (CPAP or bilevel) with the investigational mask","EXPERIMENTAL",null,[13],"Device: Investigational Mask",{"label":15,"type":16,"description":11,"interventionNames":17},"Noninvasive ventilation (CPAP or bilevel) with the conventional mask","ACTIVE_COMPARATOR",[18],"Device: Conventional mask",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Investigational Mask","Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"Conventional mask",[15],[29],{"name":30,"affiliation":31,"role":32},"William Good, Medical degree","Middlemore Hospital, New Zealand","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Valeria Mereacre, PhD Physiology","CONTACT","02102819036","val.mereacre@fphcare.co.nz",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},"Jessica Fogarin","jess.fogarin@fphcare.co.nz",[43],{"facility":44,"status":11,"city":45,"state":11,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Fisher and Paykel Healthcare Sleep Laboratory","Auckland","2013","New Zealand","NZ",{"type":50,"coordinates":51},"Point",[52,53],174.76349,-36.84853,{"lat":53,"lon":52},[56,58,59,61],{"name":40,"role":36,"phone":57,"phoneExt":11,"email":41},"7327",{"name":11,"role":36,"phone":11,"phoneExt":11,"email":38},{"name":35,"role":60,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"name":30,"role":32,"phone":11,"phoneExt":11,"email":11},{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100590835","the-effect-of-mask-design-on-ventilation-parameters-in-copd-and-ohs-patients-on-long-term-home-non-invasive-ventilation-an-experimental-study-100590835",false,"NCT06972589","The Effect of Mask Design on Ventilation Parameters 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* Allergic to adhesive of the sensors\n* Self-reported cold\u002Fflu symptoms","ALL","18 Years",{"count":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77],"NA","Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and 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. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.",[80,81],"COPD (Chronic Obstructive Pulmonary Disease)","Obesity Hypoventilation Syndrome (OHS)","NOT_YET_RECRUITING","2025-05-07",{"date":85,"type":86},"2025-05-15","ACTUAL",{"date":88,"type":74},"2025-05",{"date":90,"type":74},"2026-04",{"name":5,"class":6},1]