Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices
Recruiting · NCT07267104 · Observational (researchers observe without assigning treatment) · Lead sponsor: Corporacion Parc Tauli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study will look at people with COPD who use a home breathing machine called non-invasive ventilation (NIV). NIV machines collect information about your breathing, such as air flow, pressure, and mask leaks. Researchers want to use a computer program, called artificial intelligence (AI), to study this information. The goal is to find early signs that your breathing may be getting worse. People with COPD who already use NIV at home may join this study. The study does not change your treatment. It only uses the breathing data already recorded by your NIV machine. The computer program will look for patterns in the data. These patterns may help doctors: Notice early warning signs of a COPD flare-up Find problems with how you and the machine work together Improve the way NIV is monitored at home The main goal is to create a tool that helps patients and doctors manage home NIV more easily and more safely.
Who can take part
Inclusion criteria
- Age between 40 and 80 years.
- COPD diagnosed by pulmonary function tests.
- Home NIV therapy with good adherence (minimum daily compliance \> 5 hours) for at least 6 months.
- Users of the ResMed LUMIS 150 ventilator. This is due to the presence of the decoding tool and a larger storage capacity (more than 100 nights) in the removable device of the ventilator.
- Acute exacerbation requiring hospital admission or home care.
Exclusion criteria
- Lack of informed consent.
- Previous clinical instability defined by the need for antibiotics and/or systemic corticosteroids in the two months prior to the inclusion exacerbation, excluding the 48 hours prior to admission, as this was considered part of the inclusion clinical picture.
Where it is running
1 location listed.
- Corporation Parc Tauli de Sabadell - Sabadell, Barcelona, Spain