Not Yet RecruitingNot Applicable

RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV

250 participantsStarted 2026-08-01

Plain-language summary

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. Eligible 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. Continuous 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. The 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older. * Diagnosis of COPD according to GOLD 2026 criteria, with post-bronchodilator FEV1/FVC \< 0.70. * Severe airflow limitation, defined as FEV1 \< 50% of predicted value, corresponding to GOLD grade III-IV. * 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. Exclusion Criteria: * 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/m². * Severe cardiovascular disease, including NYHA class IV heart failure or unstable angina. * Severe renal disease receiving long-term renal replacement therapy. * Expected survival of less than 1 year, including active malignancy or end-stage systemic disease. * 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. * Refusal to participate in the study or refusal to sign informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

One-year hospitalization rate due to acute exacerbation of COPD

Timeframe: 12 months

Trial details

NCT IDNCT07701096

SponsorBeijing Chao Yang Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07-31

View on ClinicalTrials.gov More Pulmonary Disease, Chronic Obstructive (COPD) trials