Does nighttime hypoventilation predict long-term benefit from non-invasive ventilation in people with hypercapnic COPD?
Official title: Role of Nocturnal Hypoventilation in Predicting the Long-Term Ventilatory Response in Hypercapnic COPD Patients Treated With Non-Invasive Ventilation: A Prospective Observational Study With Clinical, Functional, and Radiological Assessment
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07414108 · Data updated 2026-11-12
This project tests whether nighttime hypoventilation can identify people with COPD and high CO2 who will have larger drops in arterial CO2 after 6 and 12 months on non-invasive ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07414108 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with COPD and chronic or persistent hypercapnia (PaCO2 > 50 mmHg) who require non-invasive ventilation and can attend the IRCCS AOU Bologna clinic or be hospitalized there.
✕Probably not a fit
Patients with progressive neurodegenerative disease, diaphragmatic disorders, active unstable cardiac disease, cognitive impairment preventing adherence, contraindications to NIV, or those already on home NIV are unlikely to be appropriate or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective observational cohort enrolling adults with COPD and chronic hypercapnia who start non-invasive ventilation at the Respiratory and Critical Care Unit of IRCCS AOU Bologna. Baseline overnight respiratory mechanics (including nocturnal hypoventilation and esophageal pressure swings), diaphragm thickness, and routine clinical and functional measures will be recorded. Participants will be followed at 6 and 12 months to measure changes in arterial PaCO2 and other clinical and functional outcomes. The goal is to identify baseline markers that predict sustained PaCO2 reduction with long-term NIV.
Why it matters
Potential benefit: If successful, clinicians could use nighttime breathing measures to select COPD patients most likely to get sustained CO2 reduction and fewer hospital visits from home NIV.
How similar studies have gone: Previous trials show long-term NIV can lower PaCO2 and reduce exacerbations in chronic hypercapnic COPD, but using baseline nocturnal hypoventilation and esophageal pressure measures as predictors is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients with COPD and hypercapnia, defined as PaCO₂ \> 50 mmHg either chronically or 4 weeks after an acute exacerbation requiring invasive or non-invasive mechanical ventilation * Provision of informed consent Exclusion Criteria: * Progressive neurodegenerative diseases * Diaphragmatic disorders * Severe hemodynamic instability (\>1 vasoactive agent for at least 24 hours) * Acute coronary syndrome (unstable angina / myocardial infarction) * Severe arrhythmias * Presence of contraindications to NIV * Cognitive impairment interfering with treatment adherence * Active and unstable coronary artery disease * Malignancies undergoing active treatment * Patients already receiving home non-invasive mechanical ventilation
Where it's running
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Lara Pisani, PhD
- Email: lara.pisani@unibo.it
- Phone: 0512143253
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Enhanced COPD care for people being checked for lung cancer
This project will test whether finding and treating COPD early in people being checked for possible lung cancer helps symptoms, lung function, and overall care.
-
Balance training after pulmonary rehab for COPD to help steadiness and reduce falls
A COPD-focused balance training program called Sport4Steadiness is being tested to see if people with COPD will accept it and if the study processes work well.
-
Safety and performance of the INBENTUS VERSATILE ventilator in adults on invasive mechanical ventilation
This trial will test whether the INBENTUS VERSATILE ventilator is safe and performs well in adults who need assisted or controlled invasive mechanical ventilation and short-term weaning.
-
Inhaled RB042 in healthy adults and adult smokers
This trial will try an inhaled medicine called RB042 to see if it is safe and how the body handles it in healthy adults and current adult smokers.
-
High-flow nasal cannula versus home mechanical ventilation for COPD patients with persistent high carbon dioxide after an exacerbation
This study tests whether using high-flow nasal cannula plus standard oxygen can lower CO2 as well as home mechanical ventilation plus standard oxygen in people with COPD who still have high CO2 after a severe flare.
-
Endobronchial thermal liquid ablation for treating emphysema
This study is testing a new treatment called endobronchial thermal liquid ablation to see if it can safely help people with severe emphysema breathe better and improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.