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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT04848012
Eligibility Criteria:
Patient Inclusion Criteria:
* Age ≥ 18 years
* BMI \<30 kg/m¬2
* Confirmed diagnosis of COPD
* Currently using domiciliary NIV with average reported compliance of at least 3hours
* Ability to provide informed consent
* Medical stability confirmed by recruiting physician
* Free of exacerbations for at least 2 weeks prior to enrolment
* Presence of expiratory flow limitation on forced oscillation technique criteria
Exclusion Criteria:
* Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
* Presence of major medical comorbidity, e.g. severe heart failure (LVEF \<30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
* Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Psychosocial factors that would prevent compliance with study protocol
Healthy participant inclusion criteria:
* Age ≥ 18 years
* No expiratory flow limitation on forced oscillation testing
* No acute illness on study day
* Ability to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04848012
Study Brief:
Protocol Section:
NCT04848012