Status:
RECRUITING
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Conditions:
Sleep Apnea, Obstructive
Polycythemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Objectives: To compare the response of polycythemia in terms of hematocrit decrease in patients treated with positive airway pressure (CPAP) versus patients not treated with CPAP. Methodology: Random...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06089603
Start Date
November 1 2023
End Date
September 1 2026
Last Update
September 17 2025
Active Locations (1)
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1
Aldara García-Sanchez
Madrid, Madrid, Spain, 28034