CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital Universitario Ramon y Cajal
About this trial
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.
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Continuous positive airway pressure
- Conventional pharmacological treatment
- Sleep ,diet and life style recomendations
Treatment groups
182 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov