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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT02723032
Eligibility Criteria:
Healthy volunteers
Inclusion Criteria:
* Age 18 - 60 years,
* Non smoker,
* Good general health and physical fitness
* Informed Consent
Exclusion Criteria:
* Current or history of tobacco smoking (\> 5 py)
* Current alcohol or drug abuse
* Heart disease or untreated arterial hypertension
* Pulmonary disease
* Epilepsy or other major neurologic disease
* Dark skin colour
* Known anemia
* Severe metabolic disease (e.g. diabetes)
* Pregnancy
Patients
Inclusion Criteria:
* Age ≥ 18 years
* Long term oxygen therapy at rest and/or on physical effort
* Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or \< 60 mmHg with PHT or polycythemia (men Hb \> 174 g/L, women Hb \> 140 g/L) or:
Oxygen desaturation on effort (SpO2 \< 90%)
* Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease and Sarcoidosis
* Informed Consent
Exclusion Criteria:
* Severe hypoxemia (pO2 \<40 mmHg)
* Severe hypercapnia (pCO2 \>55 mmHg)
* Acute respiratory infection or systemic infection,
* Severe systolic heart disease (LVEF \< 25%)
* Myocardial infarction during the last month before inclusion
* Unstable angina pectoris
* Severe aortic stenosis (mean gradient \> 40mmHg, valve area \<1 cm2)
* Rhythmogenic heart disease
* Severe or untreated arterial hypertension (blood pressure \> 180mmHg systolic, \>100mmHg diastolic)
* Anemia (Hb \< 120 g/l)
* Known or suspected coagulation disorder (e.g. INR \> 4)
* Severe or untreated metabolic disorder
* Neurologic disease or dementia
* Pregnancy
* History of non-compliance to medical treatment
* Current alcohol, drug abuse or current tobacco smoking
* Dark skin color
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02723032
Study Brief:
Protocol Section:
NCT02723032