[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540256":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":34,"armGroups":44,"interventions":57,"overallOfficials":66,"centralContacts":71,"locations":76,"responsibleParty":90,"collaborators":34,"id":93,"slug":34,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":34,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":34,"enrollmentInfo":101,"targetDuration":34,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":34,"overallStatus":79,"whyStopped":34,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"Asthma control questionnaire","To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)","12 months",{"measure":14,"description":15,"timeFrame":12},"Asthma control test","To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)",[17,20,23,27,31],{"measure":18,"description":19,"timeFrame":12},"Lung function- forced expiratory volume in the first second (FEV1) in spirometry","To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry",{"measure":21,"description":22,"timeFrame":12},"Lung function-forced vital capacity (FVC) in spriometry","To evaluate the impact of CPAP treatment on FVC (ml) on spirometry",{"measure":24,"description":25,"timeFrame":26},"Prevalence of OSA in severe uncontrolled asthma","Determine the prevalence of OSA in patients with severe uncontrolled asthma","Baseline",{"measure":28,"description":29,"timeFrame":30},"Inflammatory profile","Plasma proteins from peripheral blood samples will be used to analyze an inflammatory panel using a high-throughput, multiplex immunoassay technology based on Proximity Extension Assays (PEA) at baseline and after CPAP treatment","Baseline and 12 months",{"measure":32,"description":33,"timeFrame":12},"Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)","Study whether OSA ans its treatment affects quality of life in subjects with severe uncontrolled asthma based on the punctuation obtained in the mini-AQLQ questionnaire. Higher scores indicate better quality of life",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"SINGLE",[42],"OUTCOMES_ASSESSOR","Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.\n\nPrimary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and AOS.\n\nMethodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15\u002Fhour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Conservative treatment","ACTIVE_COMPARATOR","Subjects allocated to this arm will receive hygienic and dietary measures counselling",[50],"Other: Hygienic and dietary advice",{"label":52,"type":53,"description":54,"interventionNames":55},"CPAP treatment","EXPERIMENTAL","Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)",[56],"Device: CPAP treatment",[58,62],{"type":59,"name":52,"description":60,"armGroupLabels":61,"otherNames":34},"DEVICE","Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)",[52],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"Hygienic and dietary advice","Subjects allocated to this arm will receive hygienic and dietary counselling",[46],[67],{"name":68,"affiliation":69,"role":70},"Mireia Dalmases, MD","Hospital Clinic","PRINCIPAL_INVESTIGATOR",[72],{"name":68,"role":73,"phone":74,"phoneExt":34,"email":75},"CONTACT","+34932275746","mdalmase@clinic.cat",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":81,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":34},"Hospital Clinic Barcelona","RECRUITING","Barcelona","Spain","08036","ES",{"type":85,"coordinates":86},"Point",[87,88],2.15899,41.38879,{"lat":88,"lon":87},{"type":70,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Mireia Dalmases","Principal investigator","100540256",false,"NCT06314477","Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial","Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study","Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.\n* Apnea hypopnea rate greater than or equal to 15\u002Fhour\n* Punctuation in the Epworth Sleepiness Scale ≤10\n* Obtaining informed consent.\n\nExclusion Criteria:\n\n* Previous treatment with CPAP\n* Patient with central sleep apnea or Cheyne-Stokes respiration\n* Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,\n* Resistant hypertension\n* Active Smoking\n* Unstable comorbidities or medications may interfere with asthma control\n* Pregnancy\n* Any process that reduces life expectancy to \\\u003C1 year,\n* Any medical or social factor that may limit CPAP compliance","ALL","18 Years",{"count":102,"type":103},138,"ESTIMATED","INTERVENTIONAL",[106],"NA","The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)",[109,110],"Obstructive Sleep Apnea","Asthma","2025-12-04",{"date":113,"type":114},"2025-12-11","ACTUAL",{"date":116,"type":114},"2023-12-27",{"date":118,"type":103},"2026-12",{"name":5,"class":6},1]