NCT07701096Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 29 Sept 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Beijing Chao Yang Hospital
- Diseases
- COPD
- NCT number
- NCT07701096
What you commit to
- Study type: Observational
- Planned participants: 250
- From 29 Sept 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe renal disease receiving long-term renal replacement therapy.
Other illness
- 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.
- 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.
Other
- Refusal to participate in the study or refusal to sign informed consent.
Who the study is looking for
- 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 hypercapnia, defined as arterial PaCO₂ ≥ 52 mmHg (approximately 7.0 kPa) in a clinically stable state (no acute exacerbation of COPD within at least 4 weeks before enrollment), with arterial blood gas analysis performed in the sitting position at rest and after discontinuation of NPPV for at least 2 hours.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.