Actively Recruiting
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Led by Hospital Universitario Ramon y Cajal · Updated on 2025-09-17
182
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: Randomized, parallel-group, nonblinded, controlled clinical trial. Patients diagnosed with OSA in a respiratory polygraphy (RP) and who meet all the inclusion criteria and none of the exclusion criteria will undergo sleepiness and quality of life questionnaires, anthropometric measurements and blood tests and will be randomized to a CPAP treatment group or control group, maintaining this treatment for 12 months. A visit will be made at 12 weeks ,24 weeks and 52 weeks to check compliance with CPAP in the treatment group and to carry out questionnaires on physical activity and quality of life, anthropometric measurements, blood tests including hemoglobin and hematocrit as well as parameters related to coagulation and platelet function and changes in medication as well as adverse effects. Efficacy variables: blood count, hemoglobin, haematocrit, erythropoietin, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), mean platelet volume (MPV), platelets, coagulation, erythrocyte range of distribution (ADE), glucose, creatinine, glomerular filtration rate, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), Total bilirubin, hypoxic burden, Epworth score, EuroQol- 5D questionnaire.
CONDITIONS
Official Title
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects from 18 to 80 years old.
- Diagnosis of polycythemia defined as hematocrit > 49% in men and > 48% in women.
- Diagnosis of moderate or severe sleep apnea, defined by an apnea-hypopnea index >15.
- Patients able to read and understand informed consent and give their signed consent.
You will not qualify if you...
- Smokers or former smokers with pack-year index >30 or chronic obstructive pulmonary disease diagnosed by spirometry.
- 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).
- Patients with any active neoplasm.
- Patients with chronic kidney disease (glomerular filtration rate <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 baseline.
- Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization due to worsening heart failure within the previous 30 days.
- Professional drivers, high-risk professions, or respiratory failure.
- High daytime sleepiness (Epworth sleepiness scale > 16).
- Previous treatment with CPAP.
- Participation in another clinical trial within 30 days prior to randomization.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aldara García-Sanchez
Madrid, Madrid, Spain, 28034
Actively Recruiting
Research Team
A
Aldara García-Sanchez, MD, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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