RecruitingNCT07414108

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

25 participants

Start Date

Dec 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a specific pattern of abnormal breathing during sleep (called nocturnal hypoventilation) can predict how well patients with severe COPD will respond to a breathing support machine (non-invasive ventilation, or NIV) used at home long-term. **You may be eligible if...** - You are 18 or older - You have COPD with high carbon dioxide levels in your blood (above 50 mmHg), either chronically or 4 weeks after a serious flare-up requiring breathing support - You are willing to give informed consent **You may NOT be eligible if...** - You have a progressive nerve or muscle disease - You have other conditions affecting your breathing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT07414108


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