Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT07267104
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT07267104
Study Brief:
Protocol Section:
NCT07267104