Pulmonary Disease, Chronic Obstructive (COPD)RESET-COPDNCT07701096
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
An observational study of Pulmonary Disease, Chronic Obstructive (COPD) and Chronic Respiratory Failure With Hypercapnia, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia, Noninvasive Ventilation
- What is being tested?
- Not applicable- observational study
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2026to 31 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Zujin Luo, MD, +86-13810497587, xmjg2002@163.com
About this study
Official title: A Multicenter Prospective Cohort Study for Real-Time Monitoring and Intelligent Early Warning Model Development in COPD Patients Receiving Home Noninvasive Positive Pressure Ventilation
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.
Read more
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), Chronic Respiratory Failure With Hypercapnia, Noninvasive Ventilation
- Being tested
- Not applicable- observational study
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
For this observational study, participants are not assigned an intervention as part of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Number of COPD-related hospitalizations
Number of hospitalizations related to acute exacerbation of COPD during follow-up.
Measured: 12 months
Number of acute exacerbations of COPD
The total number of hospitalizations due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period.
Measured: 12 months
Emergency department visit rate due to acute exacerbation of COPD
The proportion of participants with at least one emergency department visit due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period.
Measured: 12 months
Intensive care unit admission rate due to acute exacerbation of COPD
The proportion of participants with at least one intensive care unit admission due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period.
Measured: 12 months
Invasive mechanical ventilation rate due to acute exacerbation of COPD
The proportion of participants who receive invasive mechanical ventilation due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period.
Measured: 12 months
One-year all-cause mortality
The proportion of participants who die from any cause during the 12-month follow-up period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start29 Sep 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic Obstructive (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701096
- Sponsor's protocol ID
- BeijingCYH-RESET-COPD Cohort
- Acronym
- RESET-COPD
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No