Actively Recruiting
CPAP Effect on 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of continuous positive airway pressure (CPAP) treatment on polycythemia in patients with obstructive sleep apnea (OSA). This randomized, parallel-group, nonblinded clinical trial compares patients receiving CPAP along with diet and standard pharmacological treatment to those receiving only diet and pharmacological treatment. The study focuses on changes in hematocrit levels over 12 months to understand how CPAP influences polycythemia in this patient group. Participants diagnosed with moderate to severe OSA and polycythemia will be randomly assigned to either a CPAP treatment group or a control group. The CPAP treatment involves using a nasal mask with pressure automatically adjusted by a device during sleep, combined with diet and medication. The control group receives diet and pharmacological treatment without CPAP. The treatment period lasts 12 months, with regular visits to check treatment adherence and collect data. During the study, participants will attend visits at 12, 24, and 52 weeks for assessments including blood tests measuring hematocrit, hemoglobin, coagulation, and other blood parameters. Questionnaires on sleepiness, quality of life, and physical activity will also be completed. Researchers will monitor changes in blood counts, oxygen levels during sleep, and quality of life measures to evaluate the impact of CPAP on polycythemia and related health factors.
CONDITIONS
Brief Title
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Diagnosis of polycythemia with hematocrit above 49% in men or above 48% in women
- Diagnosis of moderate or severe sleep apnea with apnea-hypopnea index greater than 15
- Ability to read, understand, and sign informed consent
You will not qualify if you...
- Current smokers or former smokers with a pack-year index over 30
- Chronic obstructive pulmonary disease diagnosed by spirometry
- Central sleep apnea or periodic breathing
- Oxygen saturation below 92% or pO2 below 60 mmHg at rest
- Severe heart failure with left ventricular ejection fraction below 50%
- Pulmonary hypertension
- Primary polycythemia vera (ruled out by blood tests and genetic testing)
- Active neoplasm
- Chronic kidney disease with glomerular filtration rate below 60 mL/min/1.73 m2
- Need for periodic bleeding according to hematology guidelines
- Treatment with diuretics, antiplatelets, or anticoagulants
- Systolic blood pressure 180 mmHg or above, or diastolic blood pressure 110 mmHg or above
- Recent stroke, transient ischemic attack, acute coronary syndrome, or heart failure hospitalization within 30 days
- Professional drivers, high-risk professions, or respiratory failure
- High daytime sleepiness with Epworth sleepiness scale above 16
- Previous treatment with CPAP
- Participation in another clinical trial within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either continuous positive airway pressure (CPAP) along with diet and conventional pharmacological treatment, or diet and conventional pharmacological treatment alone to evaluate effects on polycythemia.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Aldara García-Sanchez
Madrid, Madrid, Spain, 28034
Actively Recruiting
Research Team
A
Aldara García-Sanchez, MD, phD
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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