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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT06089603
Eligibility Criteria:
Inclusion Criteria:
* Subjects from 18 to 80 years old.
* Diagnosis of polycytemia defined as hematocrit \> 49% in men and \> 48% in women. ç
* Diagnosis of moderate or severe sleep apnea, defined by an apnea-hypoapnea index \>15. - Patients able to read and understand informed consent and give their signed consent.
Exclusion Criteria:
* Smokers or former smokers with pack-year index (IPA\>30) or chronic obstructive pulmonary disease diagnosed by spirometry (FEV1/FVC post-bronchodilator below the lower limit of normal or z score \< 1.645).
* Patients with central sleep apnea or periodic breathing
* Patients with oxygen saturation \<92% or pO2\< 60 mmHg at rest during wakefulness. - Evidence of severe heart failure (LVEF\<50) or pulmonary hypertension.
* Patients with primary polyglobulia (polycythemia vera). It will be done prior to the inclusion in the study blood levels of erythropoietin (EPO) and determination of the mutation of the JAK2 V617F gene. Patients with normal or elevated EPO levels (normal limits 2.9- 25.9 mU/ml) and no JAK2 V617F gene mutation
* Patients with any active neoplasm will be included in the study. - Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) \<60 mL/min/1.73 m2).
* Patients with any active neoplasia.- Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) \<60 mL/min/1.73 m2).
* Need for periodic bleeding according to hematology guidelines.
* Treatment with diuretics.
* Treatment with antiplatelets or anticoagulants.
* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at the baseline visit.
* Stroke, transient ischemic attack, acute coronary syndrome or hospitalization due to worsening heart failure, in the previous 30 days .
* Professional drivers, high-risk profession or respiratory failure (according to criteria of the clinical path of diagnosis and treatment of sleep-related respiratory disorders).
* High daytime sleepiness (Epworth sleepiness scale \> 16)
* Previous treatment with CPAP- Participation in another clinical trial within 30 days prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06089603
Study Brief:
Protocol Section:
NCT06089603