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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02446769
Eligibility Criteria:
Inclusion Criteria:
1. Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
2. Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; \>3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge.
3. Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 \<70% predicted post BD).
4. No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year
Exclusion Criteria:
1. Central sleep apnea (Central apnea index \>5 per hour; and/or \>50% are central apneas \& hypopneas)
2. Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator
3. Participants with Stage III \& IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
4. Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
5. Lack of medical insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02446769
Study Brief:
Protocol Section:
NCT02446769