Predicting COPD flare-ups from data recorded by home non-invasive ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, longitudinal analysis of detailed pressure, flow and leak data recorded by home non-invasive ventilation (NIV) devices in people with COPD who meet adherence criteria. Participants continue their usual treatment and devices' archived data (from ResMed LUMIS 150 units) are decrypted, converted to an open format, and analyzed. Machine learning methods such as random forests and neural networks will be used to identify patterns that predict exacerbations and detect patient–ventilator asynchrony. The goal is to develop an automated predictive tool to improve remote monitoring and personalise home NIV management.

Why it matters

Who can join: the full rules

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's running

• Corporation Parc Tauli de Sabadell
  Sabadell, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Manel Lujan, Professor MD pHD
• Email: mlujan@tauli.cat
• Phone: +34 937231010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.