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 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT01586728
Eligibility Criteria:
Inclusion Criteria:
* Children ≥ 6 years and adults ≥ 18 years with CF in a stable state
* With a forced expiratory volume in one second (FEV1) ≤ 50% of predicted value
* Having a pulse oximetry (SpO2) in room air ≤ 90% for ≥ 10% of the night and/or a SpO2 ≤ 90% for ≥ 10 minutes during the night
* Any patient with prior noninvasive positive pressure ventilation (NPPV) but who has stopped NPPV at least 15 days before the start of the study.
* Written approval by the patient and by the parents in case of a pediatric patient
* Patient having the French social security coverage
Exclusion Criteria:
* Patients with a respiratory exacerbation during the last 15 days
* Patients with NPPV or long term oxygen therapy prior to the start of the study and unable to stop this treatment
* Impossibility of a medical examination
* Pregnant patient or breastfeeding patient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01586728
Study Brief:
Protocol Section:
NCT01586728