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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT03421704
Eligibility Criteria:
Inclusion Criteria:
* Indication and prescription of PR DS-autoSV
* Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation
Exclusion Criteria:
* Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (\> 50 % of events)
* Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition
* Chronic conditions with life expectancy \< 1 year
* Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC \< 70% (GOLD III)
* Respiratory insufficiency requiring long-term oxygen therapy
* Daytime hypercapnia at rest (pCO2 \> 45 mmHg)
* Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment
* Cardiac resynchronization or pacemaker implantation within the last 6 months
* Untreated or therapy refractory Restless legs-Syndrome (RLS)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03421704
Study Brief:
Protocol Section:
NCT03421704