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

NCT07701096 | Not Yet Recruiting DMC

• 1 other identifier: BeijingCYH-RESET-COPD Cohort
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD); Noninvasive Ventilation; Chronic Respiratory Failure With Hypercapnia

Outcome Measures

Primary Outcomes (1)

• One-year hospitalization rate due to acute exacerbation of COPD

  The proportion of participants who experience at least one hospitalization due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period. Hospitalization due to acute exacerbation of COPD will be confirmed based on symptom worsening, treatment or healthcare utilization, exclusion of alternative explanations, and investigator adjudication.

  12 months

Secondary Outcomes (6)

• Number of COPD-related hospitalizations

  12 months

• Number of acute exacerbations of COPD

  12 months

• Emergency department visit rate due to acute exacerbation of COPD

  12 months

• Intensive care unit admission rate due to acute exacerbation of COPD

  12 months

• Invasive mechanical ventilation rate due to acute exacerbation of COPD

  12 months

Interventions

Home NPPV DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from adult patients with severe chronic obstructive pulmonary disease and chronic hypercapnic respiratory failure who are managed at participating clinical centers and who are receiving or newly initiating home noninvasive positive pressure ventilation. The study population will include clinically stable COPD patients with severe airflow limitation and persistent hypercapnia who are suitable for home NPPV follow-up and multisensor real-time monitoring.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07