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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03043703
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged ≥18 years who are able to understand and follow the instructions of the study personnel
2. Patients with an indication for PAP therapy or currently adherent to PAP therapy (device usage ≥4 h/ night) for moderate to severe sleep apnoea and diagnostic AHI ˃15/h and/or a residual CAI ˃5/h
3. Patients with currently titrated fixed CPAP pressure ≥8 cmH2O; or 95th percentile APAP pressure ≥8 cmH2O; or ASV therapy with a 95th percentile IPAP of ≥8 cmH2O
4. Patients who are established PAP users (PAP use duration ≥6 weeks)
5. Dated and signed written informed consent
Exclusion Criteria:
1. Patients with moderate to severe obstructive airway disease and/or respiratory insufficiency
2. Patients with heart failure in NYHA class III or IV, unstable hypertension, paroxysmal/persistent atrial fibrillation, unstable angina pectoris, cardiac or cerebral ischemic events within the last 6 months before screening
3. Patients with current primary or secondary insomnia
4. Patients who are pregnant or breastfeeding
5. Patients who are physically unable to comply with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03043703
Study Brief:
Protocol Section:
NCT03043703