Sleep apnea machine may also treat blood disorder
NCT ID NCT06089603
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study tests whether using a CPAP machine at night can reduce high red blood cell counts (polycythemia) in people with moderate to severe sleep apnea. Researchers will compare 182 adults who use CPAP plus standard care to those who receive only standard care over 12 months. The main goal is to see if CPAP lowers hematocrit levels, which could reduce the risk of blood clots and other complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Continuous positive airway pressure (CPAP) device
- What this could lead to
- If successful, CPAP could become a standard treatment to reduce high red blood cell counts in people with sleep apnea, potentially lowering their risk of blood clots and other complications.
- What could go wrong
- This is a Phase 4 trial, so CPAP is already approved for sleep apnea, but its effect on polycythemia is not yet proven. The study is not blinded, which could introduce bias, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 182 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aldara García-Sanchez
RECRUITINGMadrid, Madrid, 28034, Spain
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