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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT03522805
Eligibility Criteria:
Inclusion Criteria:
* Subjects with previously diagnosed severe COPD (FEV1 \<50% predicted) and daytime hypercapnia (PaCO2 or TcCO2 \> 45 mmHg)
Exclusion Criteria:
* Lung disease besides COPD (e.g., pulmonary fibrosis, bronchiectasis, pulmonary arterial hypertension) other than well controlled asthma
* Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
* Uncontrolled hypertension (SBP \>160, DBP \>95)
* Unwilling or unable to withhold CPAP during polysomnography
* Presence of tracheostomy
* Hospitalization within the past 90 days
* Prior peptic ulcer disease, esophageal varicies, or gastrointestinal bleeding (\< 5 years)
* Prior gastric bypass surgery
* Anticoagulant use (other than aspirin) or bleeding diathesis (only for esophageal catheter placement)
* Chronic liver disease or end-stage kidney disease
* Allergy to any of the study medications
* Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)
* Insomnia or circadian rhythm disorder
* Active illicit substance use or \>3 oz nightly alcohol use
* Psychiatric disease, other than controlled depression
* Pregnancy
* Prisoners
* Cognitive impairment, unable to provide consent, or unable to carry out research procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT03522805
Study Brief:
Protocol Section:
NCT03522805