[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645433":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":13,"collaborators":7,"id":15,"slug":16,"hasResults":17,"nctId":18,"briefTitle":19,"officialTitle":20,"acronym":21,"eligibilityCriteria":22,"healthyVolunteers":17,"sex":23,"minAge":24,"maxAge":7,"enrollmentInfo":25,"targetDuration":7,"studyType":28,"phases":7,"briefSummary":29,"conditions":30,"keywords":7,"overallStatus":34,"whyStopped":7,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":7},{"fullName":5,"class":6},"Beijing Chao Yang Hospital","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Home NPPV","Home noninvasive positive pressure ventilation is used as part of routine clinical care in patients with severe COPD and chronic hypercapnic respiratory failure. Ventilator mode, pressure settings, oxygen supplementation, adherence, tolerance, complications, and device safety will be prospectively recorded during follow-up.",{"type":14,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100645433","reset-copd-cohort-real-time-monitoring-and-early-warning-in-copd-patients-receiving-home-nppv-100645433",false,"NCT07701096","RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV","A Multicenter Prospective Cohort Study for Real-Time Monitoring and Intelligent Early Warning Model Development in COPD Patients Receiving Home Noninvasive Positive Pressure Ventilation","RESET-COPD","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of COPD according to GOLD 2026 criteria, with post-bronchodilator FEV1\u002FFVC \\\u003C 0.70.\n* Severe airflow limitation, defined as FEV1 \\\u003C 50% of predicted value, corresponding to GOLD grade III-IV.\n* Chronic hypercapnic respiratory failure, defined as arterial PaCO₂ ≥ 53 mmHg or ≥ 7.0 kPa while breathing room air in a clinically stable state, that is, no acute exacerbation of COPD within at least 4 weeks before enrollment.\n\nExclusion Criteria:\n\n* Chronic respiratory failure caused by diseases other than COPD, including neuromuscular diseases, chest wall deformity, obstructive sleep apnea, or severe obesity with BMI \\> 35 kg\u002Fm².\n* Severe cardiovascular disease, including NYHA class IV heart failure or unstable angina.\n* Severe renal disease receiving long-term renal replacement therapy.\n* Expected survival of less than 1 year, including active malignancy or end-stage systemic disease.\n* Inability to complete the study, including cognitive impairment, psychiatric disease, inability to cooperate with NPPV, inability to use wearable devices, or inability to complete follow-up.\n* Refusal to participate in the study or refusal to sign informed consent.","ALL","18 Years",{"count":26,"type":27},250,"ESTIMATED","OBSERVATIONAL","This is a multicenter prospective cohort study designed to develop and validate a multisensor-based real-time monitoring and intelligent early warning model for acute exacerbations in patients with chronic obstructive pulmonary disease receiving home noninvasive positive pressure ventilation.\n\nEligible participants will be adults with severe COPD and chronic hypercapnic respiratory failure who are receiving or newly initiating home noninvasive positive pressure ventilation. Participants will undergo baseline assessment and follow-up visits at 3, 6, and 12 months. Clinical data, arterial blood gas measurements, pulmonary function, exercise capacity, symptom burden, health-related quality of life, psychological status, home noninvasive ventilation parameters, adherence, device-related adverse events, healthcare utilization, acute exacerbations, hospitalizations, intensive care unit admissions, invasive mechanical ventilation, and mortality will be collected.\n\nContinuous physiological monitoring data, will be used to construct individualized stable baseline values and to identify digital warning signals. Digital warning events will be further adjudicated through symptom confirmation, treatment and healthcare utilization verification, exclusion of alternative explanations, and investigator assessment.\n\nThe study aims to establish a longitudinal clinical and physiological dataset for COPD patients receiving home noninvasive ventilation and to evaluate the performance of a multisensor-based early warning model for clinically confirmed acute exacerbations of COPD.",[31,32,33],"Pulmonary Disease, Chronic Obstructive (COPD)","Chronic Respiratory Failure With Hypercapnia","Noninvasive Ventilation","NOT_YET_RECRUITING","2026-07-08",{"date":37,"type":38},"2026-07-14","ACTUAL",{"date":40,"type":27},"2026-08-01",{"date":42,"type":27},"2028-07-31",{"name":5,"class":6}]