NCT07414108Recruiting
How Nocturnal Hypoventilation Predicts Long-term Response to Non-invasive Ventilation in Hypercapnic COPD Patients
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
The study is an observational, single-center, prospective cohort study aiming to evaluate respiratory mechanics data, as well as clinical and functional parameters commonly used in clinical practice in patients with COPD and hypercapnic respiratory failure. The study population consists of patients with COPD and hypercapnia requiring NIV. The primary objective of the study is to evaluate the association between the reduction in partial pressure of carbon dioxide in arterial blood (PaCO₂) levels at 6 and 12 months after initiating non-invasive ventilation (NIV) and the presence of nocturnal hypoventilation detected at baseline in patients with COPD and chronic hypercapnia. Secondary objectives of this study are the evaluation of the following parameters measured at baseline and/or after 6 and 12 months of NIV treatment in patients with COPD and chronic hypercapnia: * Magnitude of esophageal pressure swing during nocturnal monitoring. * Diaphragm thickness and diaphragmatic thickening fraction assessed by thoracic ultrasound. * Presence of overlap syndrome (COPD + OSA). * Radiological classification of COPD subtypes to assess the association between radiological findings, functional profile, severity of nocturnal hypoventilation, and patterns of chronic hypercapnia. * Respiratory functional parameters, including FEV₁, FVC, FEV₁/FVC ratio, carbon monoxide diffusion capacity (DLCO), and airway resistance (R5 and R20). * Frequency of severe exacerbations and subsequent rehospitalizations during follow-up. * Rate of compliance with respiratory treatment.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- 10 Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- COPD
- NCT number
- NCT07414108
What you commit to
- Study type: Observational
- Planned participants: 25
- From 10 Dec 2025 to the primary completion date, Dec 2027
- 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
- Patients already receiving home non-invasive mechanical ventilation
Other illness
- Progressive neurodegenerative diseases
- Diaphragmatic disorders
- Acute coronary syndrome (unstable angina / myocardial infarction)
- Severe arrhythmias
- Cognitive impairment interfering with treatment adherence
- Active and unstable coronary artery disease
- Malignancies undergoing active treatment
Other
- Severe hemodynamic instability (\>1 vasoactive agent for at least 24 hours)
- Presence of contraindications to NIV
Who the study is looking for
- 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
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 |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.