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Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices
NCT07267104 · Corporacion Parc Tauli
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
SAGE-NIV: Surveillance and Artificial Intelligence Guidance for Exacerbations in COPD Patients With Home Non-Invasive Ventilation
About this study
This study proposes the development of an artificial intelligence (AI) system to monitor and analyse detailed non-invasive mechanical ventilation (NIV) data in COPD patients, with the aim of predicting clinical exacerbations and improving home management.
Analysis of data from home NIV devices allows assessment of patient compliance, detection of leaks and asynchronies, and monitoring of upper airway events. However, the potential of these data to improve ventilation management in COPD patients has been limited, in part due to the lack of tools to process and interpret the detailed records. Transforming these data into an open format opens up the possibility of applying artificial intelligence to analyse large amounts of information and develop predictive models.
The multi-centre, observational, longitudinal study design will include COPD patients on NIV therapy who meet adherence criteria. Detailed leak, pressure and flow time data, previously decrypted and converted into a data format readable by analysis software, will be analysed. The identified metrics will be evaluated by machine learning algorithms using techniques such as random forest and neural networks.
Expected outcomes include the development of an automated predictive model to enable early detection of exacerbations and improved patient-ventilator synchronisation, moving towards more efficient and personalised telemonitoring in home NIV management.
Eligibility criteria
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.
Study design
Enrollment target: 75 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-03-25
Estimated completion: 2026-12
Last updated: 2025-12-05
Interventions
Other: The intervention involves download data of ventilator with clinical dates of the patient and model ventilator and parameters in acute exacebartion fo COPD
Primary outcomes
- • Mean expiratory constant time (seconds) (the 10 days prior to the admission, which will be the reason for recruitment, and the 10 days that will act as a control)
Sponsor
Corporacion Parc Tauli · other
Contacts & investigators
ContactManel Lujan, Professor MD pHD · contact · mlujan@tauli.cat · +34 937231010
ContactCristina Lalmolda Puyol, RT phD · contact · clalmolda@tauli.cat · +34 692186820
All locations (1)
Corporation Parc Tauli de SabadellRecruiting
Sabadell, Barcelona, Spain