NCT07267104Recruiting
Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices
SAGE-NIV: Surveillance and Artificial Intelligence Guidance for Exacerbations in COPD Patients With Home Non-Invasive Ventilation
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 25 Mar 2025
- Primary completion date
- 19 Apr 2025
- Lead sponsor
- Corporacion Parc Tauli
- Diseases
- COPD
- NCT number
- NCT07267104
What you commit to
- Study type: Observational
- Planned participants: 75
- From 25 Mar 2025 to the primary completion date, 19 Apr 2025
- 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
- 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.
Other
- Lack of informed consent.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · 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 |
|---|---|---|---|
| Corporation Parc Tauli de Sabadell Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.