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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT05815420
Eligibility Criteria:
Inclusion criteria:
* Age ≥18 years
* COPD eligible for NIV treatment
* Prescription of an adequate ResMed NIV device with tele-monitoring option as part of routine clinical care
* Acceptance of tele-monitoring and corresponding data handling
* Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study
* Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data.
Exclusion criteria:
* Invasive ventilation therapy
* Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer)
* Further exclusion criteria according to manua of the device intended and prescribed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05815420
Study Brief:
Protocol Section:
NCT05815420