CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
NCT ID: NCT06089603
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
182 participants
INTERVENTIONAL
2023-11-01
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPAP treatment
Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP)
Continuous positive airway pressure
Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)
Conventional pharmacological treatment
Usual treatment of the patient
Sleep ,diet and life style recomendations
Daily recomendatios
Control treatment
Diet and conventional pharmacological treatment
Conventional pharmacological treatment
Usual treatment of the patient
Sleep ,diet and life style recomendations
Daily recomendatios
Interventions
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Continuous positive airway pressure
Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)
Conventional pharmacological treatment
Usual treatment of the patient
Sleep ,diet and life style recomendations
Daily recomendatios
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Aldara García-Sánchez
M.D, pHD
Principal Investigators
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Aldara García-Sanchez, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Hospital Ramon y Cajal
Locations
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Aldara García-Sanchez
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Aldara Garcia-Sanchez, MD, phD
Role: primary
Other Identifiers
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HURyC 207/23
Identifier Type: -
Identifier Source: org_study_id
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