[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551705":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":45,"locations":53,"responsibleParty":69,"collaborators":71,"id":74,"slug":26,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":26,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Conventional hygienic-dietary recommendations and promotion of daily physical activity",[13],"Other: Hygienic-dietary recommendations and daily physical activity promotion",{"label":15,"type":16,"description":17,"interventionNames":18},"CPAP group","EXPERIMENTAL","Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP)",[19,13],"Device: Continuous positive airway pressure",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Continuous positive airway pressure","Treatment will start with an empirical pressure of 8 cmH2O and, within a maximum of 3 weeks, the pressure will be adjusted by means of automatic titration, establishing the pressure corresponding to the 95th percentile.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Hygienic-dietary recommendations and daily physical activity promotion","Hygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated.",[15,9],[32,36,39,41,43],{"name":33,"affiliation":34,"role":35},"Maria Angeles Ruiz-Cobos, MD","Hospital Universitario del Henares","STUDY_CHAIR",{"name":37,"affiliation":34,"role":38},"Ana De la Rocha Prieto, MD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":34,"role":38},"Julia Dorta Díez de la Lastra, MD",{"name":42,"affiliation":5,"role":38},"Raquel Casitas, MD",{"name":44,"affiliation":34,"role":38},"Marina Blanco Cruz, ND",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Francisco Garcia-Rio, MD","CONTACT","+34639911718","fgr01m@gmail.com",{"name":52,"role":48,"phone":49,"phoneExt":26,"email":50},"Francisco Garcia-Rio",[54],{"facility":34,"status":55,"city":56,"state":57,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Coslada","Madrid","28822","Spain",{"type":61,"coordinates":62},"Point",[63,64],-3.56129,40.42378,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":26,"phoneExt":26,"email":26},"Angeles Ruiz-Cobos, MD",{"type":38,"investigatorFullName":52,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PhD",[72],{"name":34,"class":73},"UNKNOWN","100551705",false,"NCT06463561","CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea","Effect of 12 Months of Treatment With Continuous Positive Airway Pressure on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea. A Randomized, Open-labell, Parallel Clinical Trial","CPAPLIP","Inclusion Criteria:\n\n* Subjects from 35 to 80 years old\n* Diagnosis of dyslipidemia. It will be considered as such, the existence of a previous clinical record of a diagnosis of dyslipidemia associated with treatment with lipidlowering agents, treatment with lipid-lowering agents or the presence of an altered blood test in the last two months, using the following cut-off points: total cholesterol ≥ 200 mg\u002Fdl, triglycerides ≥ 180 mg\u002Fdl, HDL-cholesterol ≤ 40 mg\u002Fdl or LDL-cholesterol ≥ 150 mg\u002Fdl.\n* Moderate-severe sleep apnea, defined by AHI \\> 15 h-1 .\n\nExclusion Criteria:\n\n* Predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events.\n* Patients with indications for CPAP treatment according to the International Sleep Consensus: hypertensive, excessive daytime sleepiness (Epworth Sleepiness Scale \\> 11) or impaired sleep-related quality of life considered relevant by their regular physician.\n* Professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing).\n* Pretreatment with CPAP","ALL","35 Years","80 Years",{"count":85,"type":86},220,"ESTIMATED","INTERVENTIONAL",[89],"PHASE4","Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia.\n\nObjectives:\n\nMain objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA.\n\nSecondary objectives:\n\n* To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA.\n* To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA.\n* To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA.\n* To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA.\n* To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA.\n* To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA.\n* To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones.\n* To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid.\n\nDesign Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment.\n\nStudy population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications.\n\nSample size: 110 patients in each treatment arm.\n\nTreatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms:\n\n1. Conventional hygienic-dietary recommendations and promotion of daily physical activity.\n2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP).\n\nEfficiency variables\n\n* Main variables: LDL-cholesterol and uric acid.\n* Total cholesterol, HDL-cholesterol and triglycerides.\n* Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein.\n* Systemic biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A\u002Fhypocretin 1 and ghrelin).\n* Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.\n\nSafety variables\n\n* Clinical adverse event reporting.\n* CPAP compliance (average hours of use per day).\n* Epworth Sleepiness Questionnaire.\n* Development of cardiovascular events.",[92,93,94],"Sleep Apnea","Dyslipidemias","Hyperuricemia","2024-07-11",{"date":97,"type":98},"2024-07-15","ACTUAL",{"date":100,"type":98},"2024-07-12",{"date":102,"type":86},"2028-01-31",{"name":5,"class":6},1]