[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital Universitario Ramon y Cajal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100522975","phase-4-cpap-effect-on-the-polycythemia-in-patients-with-obstructive-sleep-apnea-100522975",false,"NCT06089603","CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea","PoliAOS","Inclusion Criteria:\n\n* Subjects from 18 to 80 years old.\n* Diagnosis of polycytemia defined as hematocrit \\> 49% in men and \\> 48% in women. ç\n* 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.\n\nExclusion Criteria:\n\n* Smokers or former smokers with pack-year index (IPA\\>30) or chronic obstructive pulmonary disease diagnosed by spirometry (FEV1\u002FFVC post-bronchodilator below the lower limit of normal or z score \\\u003C 1.645).\n* Patients with central sleep apnea or periodic breathing\n* Patients with oxygen saturation \\\u003C92% or pO2\\\u003C 60 mmHg at rest during wakefulness. - Evidence of severe heart failure (LVEF\\\u003C50) or pulmonary hypertension.\n* 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\u002Fml) and no JAK2 V617F gene mutation\n* Patients with any active neoplasm will be included in the study. - Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2).\n* Patients with any active neoplasia.- Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2).\n* Need for periodic bleeding according to hematology guidelines.\n* Treatment with diuretics.\n* Treatment with antiplatelets or anticoagulants.\n* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at the baseline visit.\n* Stroke, transient ischemic attack, acute coronary syndrome or hospitalization due to worsening heart failure, in the previous 30 days .\n* Professional drivers, high-risk profession or respiratory failure (according to criteria of the clinical path of diagnosis and treatment of sleep-related respiratory disorders).\n* High daytime sleepiness (Epworth sleepiness scale \\> 16)\n* Previous treatment with CPAP- Participation in another clinical trial within 30 days prior to randomization.","ALL","18 Years","80 Years",{"count":20,"type":21},182,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","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.\n\nMethodology: Randomized, parallel-group, nonblinded, controlled clinical trial.\n\nPatients 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.\n\nEfficacy 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.",[27,28],"Sleep Apnea, Obstructive","Polycythemia","RECRUITING","2025-09-11",{"date":32,"type":33},"2025-09-17","ACTUAL",{"date":35,"type":33},"2023-11-01",{"date":37,"type":21},"2026-09",{"name":39,"class":40},"Hospital Universitario Ramon y Cajal","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100593036","effect-of-cpap-versus-apap-in-patients-with-obesity-undergoing-bariatric-surgery-protocol-100593036","NCT07001215","Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol","ObesAOS","Inclusion Criteria:\n\n* Subjects aged 18 to 80 years who meet the criteria for bariatric surgery and are on the surgical waiting list after approval by the bariatric surgery committee (BMI ≥35, or BMI ≥30 with comorbidities).\n* Diagnosis of moderate or severe sleep apnea, defined by an Apnea-Hypopnea Index (AHI) \\>15, requiring treatment according to protocol (\"Patients with an AHI of 15 or higher will be treated with CPAP if they have hypertension, excessive daytime sleepiness, or sleep-related symptoms not explained by other causes\" \\[17\\]).\n* Patients must be able to read and understand the informed consent and provide signed consent.\n\nExclusion Criteria:\n\n* Patients with central sleep apnea or periodic breathing\n* Patients with any active neoplasm\n* Patients with severe uncontrolled psychiatric disorders, alcoholism, or active drug addiction\n* Patients with unacceptable surgical\u002Fanesthetic risk\n* Patients who have undergone previous surgery for OSA or who have been treated with positive airway pressure and did not tolerate it",{"count":50,"type":21},104,[52],"NA","Introduction Obstructive sleep apnea (OSA) is a common disorder in obese patients, especially those undergoing bariatric surgery. OSA is characterized by upper airway obstruction during sleep, leading to intermittent hypoxia and sleep fragmentation. Obesity and OSA are closely related conditions that can exacerbate each other. Positive airway pressure therapy is essential for managing OSA, but adherence to therapy can be challenging, particularly in patients who experience rapid physiological changes after bariatric surgery.\n\nObjective This study aims to determine whether automatic positive airway pressure therapy (APAP) improves nightly usage hours compared to continuous positive airway pressure therapy (CPAP) in obese patients undergoing bariatric surgery. Secondary objectives include evaluating the percentage of nights with therapy use over 4 hours, reduction of the residual apnea-hypopnea index (AHI), changes in daytime sleepiness, pressure requirements, side effects, sleep-related quality of life, reduction in in-person visits, and optimization of healthcare resources.\n\nMethodology A randomized, parallel-group, open-label, controlled clinical trial will be conducted. Adult patients eligible for bariatric surgery with a diagnosis of moderate to severe OSA (AHI \\> 15) requiring positive pressure therapy will be included. Participants will be randomized to receive either APAP or CPAP. Follow-up will be conducted over 12 months after surgery, with assessments at 3, 6, and 12 months. Data will be collected on treatment adherence, residual AHI, OSA symptoms, daytime sleepiness, quality of life, and treatment costs.\n\nAPAP therapy is expected to improve nightly usage hours compared to CPAP. It is also expected that APAP will show better adaptation to changing pressure needs after bariatric surgery. Data will be analyzed to evaluate the effectiveness and cost-efficiency of both therapies.\n\nThis study will provide evidence on the efficacy of APAP compared to CPAP in obese patients undergoing bariatric surgery. The results will help optimize the treatment of OSA in this population and improve patients' quality of life. Additionally, the study is expected to contribute to the optimization of healthcare resources by reducing in-person visits and repeated sleep studies.",[27,55,56,57,58],"Bariatric Surgery","Obesity","Treatment Adherence and Compliance","Continuous Positive Airway Pressure (CPAP)",[60,58,61,55,56],"Obstructive Sleep Apnea (OSA)","Automatic Positive Airway Pressure (APAP)","NOT_YET_RECRUITING","2025-07-17",{"date":65,"type":33},"2025-07-23",{"date":67,"type":21},"2025-09-15",{"date":69,"type":21},"2028-09-15",{"name":39,"class":40},""]