Effect of CPAP on blood conditions in sleep apnea patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effects of continuous positive airway pressure (CPAP) treatment on hematocrit levels in patients with obstructive sleep apnea (OSA) and polycythemia. Participants aged 18 to 80 diagnosed with moderate to severe OSA will be randomized into two groups: one receiving CPAP treatment and the other receiving conventional pharmacological treatment. Over a 12-month period, patients will undergo regular assessments including questionnaires on sleepiness and quality of life, anthropometric measurements, and blood tests to monitor changes in hematocrit and other health parameters. The study will evaluate the effectiveness of CPAP in reducing polycythemia in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aldara García-Sanchez
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Aldara García-Sanchez, MD, phD — Hospital Ramon y Cajal
• Study coordinator: Aldara García-Sanchez, MD, phD
• Email: aldara.garcia.ag@gmail.com
• Phone: +34686810368

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.