CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Key facts
- Who runs it
- Hospital Universitario Ramon y Cajal
- Where
- Madrid, SpainSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 182 people, planned
- Started
- 1 Nov 2023
- Planned end
- Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Continuous positive airway pressure
- Conventional pharmacological treatment
- Sleep ,diet and life style recomendations
- Record updated
- 17 September 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Treatment with diuretics
- Treatment with antiplatelets or anticoagulants
- Stroke, transient ischemic attack, acute coronary syndrome or hospitalization due to worsening heart failure, in the previous 30 days
- Previous treatment with CPAP- Participation in another clinical trial within 30 days prior to randomization
- 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)
- Need for periodic bleeding according to hematology guidelines
- Professional drivers, high-risk profession or respiratory failure (according to criteria of the clinical path of diagnosis and treatment of sleep-related respiratory disorders)
- 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 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)
- Patients with central sleep apnea or periodic breathing
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at the baseline visit
- High daytime sleepiness (Epworth sleepiness scale > 16)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Spain
- Aldara García-SanchezMadrid, SpainContact: Aldara Garcia-Sanchez, MD, phDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- CPAP treatmentTreatment being tested
Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP)
Treatment: Continuous positive airway pressure, Conventional pharmacological treatment, and Sleep ,diet and life style recomendations
- Control treatmentExisting treatment, for comparison
Diet and conventional pharmacological treatment
Treatment: Conventional pharmacological treatment and Sleep ,diet and life style recomendations
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06089603, who can take part
- Record updated
- 17 September 2025