[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535097":3},{"organization":4,"outcomesModule":7,"designInfo":97,"detailedDescription":104,"studyPopulation":100,"armGroups":105,"interventions":118,"overallOfficials":128,"centralContacts":132,"locations":138,"responsibleParty":167,"collaborators":170,"id":199,"slug":100,"hasResults":200,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":200,"sex":206,"minAge":207,"maxAge":100,"enrollmentInfo":208,"targetDuration":100,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":100,"overallStatus":141,"whyStopped":100,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Skane University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":93},[9],{"measure":10,"description":11,"timeFrame":12},"Time to first hospitalization or death from all causes","Time to first hospitalization or death from all causes during 1 year after randomization in people with COPD (assessed using nationwide registry data)","1 year",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,66,69,72,75,78,81,84,87,90],{"measure":15,"description":16,"timeFrame":12},"Time to first all-cause hospitalization or all-cause death","Time to first all-cause hospitalization or all-cause death in people with ILD (assessed using nationwide registry data)",{"measure":18,"description":19,"timeFrame":12},"Rate of hospitalizations or death from all causes","Rate of hospitalizations or death from all causes assessed using nationwide registry data",{"measure":21,"description":22,"timeFrame":12},"Hospitalization rate from all causes","Hospitalization rate from all causes assessed using nationwide registry data",{"measure":24,"description":25,"timeFrame":12},"Hospitalization rate from respiratory disease","Hospitalization rate from respiratory disease assessed using nationwide registry data",{"measure":27,"description":28,"timeFrame":12},"Number of hospitalized days","Number of hospitalized days from all-causes, respiratory and cardiovascular disease using nationwide registry data",{"measure":30,"description":31,"timeFrame":12},"Hospitalization rate from cardiovascular disease","Hospitalization rate from cardiovascular disease assessed using nationwide registry data",{"measure":33,"description":34,"timeFrame":12},"Number of admissions to intensive care unit (ICU)","Number of admissions to ICU assessed using nationwide registry data",{"measure":36,"description":37,"timeFrame":12},"Number of days in ICU","Number of days in ICU assessed using nationwide registry data",{"measure":39,"description":40,"timeFrame":12},"Mortality rate from all causes","The mortality rate from all causes assessed using nationwide registry data",{"measure":42,"description":43,"timeFrame":12},"Mortality rate from respiratory disease","The mortality rate from respiratory disease assessed using nationwide registry data",{"measure":45,"description":46,"timeFrame":12},"Mortality rate from cardiovascular disease","The mortality rate from cardiovascular disease assessed using nationwide registry data",{"measure":48,"description":49,"timeFrame":12},"Time to first exacerbation","Time to first exacerbation after randomisation, defined as time to first dispensed antibiotics and\u002For oral corticosteroids, ED-visit or hospitalization for exacerbation assessed using self-reported and registry data",{"measure":51,"description":52,"timeFrame":12},"Number of exacerbations","Number of exacerbations of all severity assessed using self-reported and registry data",{"measure":54,"description":55,"timeFrame":12},"Incidence of cardiovascular disease","Incidence of cardiovascular disease assessed using nationwide registry data",{"measure":57,"description":58,"timeFrame":12},"Need for home mechanical ventilation","Need for starting home mechanical ventilation assessed using nationwide registry data",{"measure":60,"description":61,"timeFrame":12},"Rate of withdrawal of long-term oxygen therapy","Rate of withdrawal of long-term oxygen therapy assessed using nationwide registry data",{"measure":63,"description":64,"timeFrame":65},"Adverse events","Self-reported adverse events since study start assessed using a postal questionnaire.","3 and 12 months",{"measure":67,"description":68,"timeFrame":12},"Primary care utilization","Self-reported number of primary care contacts since the start of the study assessed using a postal questionnaire.",{"measure":70,"description":71,"timeFrame":65},"Health-related quality of life","Self-reported health-related quality of life assessed using the EuroQol Five Dimensions - Five Levels (EQ5D-5L) questionnaire.",{"measure":73,"description":74,"timeFrame":65},"Health status","Self-reported health status assessed using the and the COPD Assessment Test (CAT) questionnaire.",{"measure":76,"description":77,"timeFrame":65},"Breathlessness at exertion","Self-reported exertional breathlessness assessed using the Dyspnoea Exertion Scale (DES) questionnaire.",{"measure":79,"description":80,"timeFrame":65},"Breathlessness","Self-reported breathlessness assessed using the Dyspnea-12 questionnaire.",{"measure":82,"description":83,"timeFrame":65},"Sleep quality","Self-reported sleep quality assessed using the modified Basic Nordic Sleep Questionnaire.",{"measure":85,"description":86,"timeFrame":65},"Physical activity","Self-reported level of physical activity assessed using the modified Grimby-Frändin questionnaire.",{"measure":88,"description":89,"timeFrame":65},"Change in health status","Self-reported change in perceived health status assessed using the Global Impression of Change (GIC) scale.",{"measure":91,"description":92,"timeFrame":65},"Nasal symptoms","Self-reported nasal symptoms assessed using the modified Björklund questionnaire.",[94],{"measure":95,"description":96,"timeFrame":65},"Patient preference for continuing the treatment","Patients' self-reported patient preference for continuing the treatment assessed using postal questionnaire.",{"allocation":98,"interventionModel":99,"interventionModelDescription":100,"primaryPurpose":101,"observationalModel":100,"timePerspective":100,"maskingInfo":102},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":103,"maskingDescription":100,"whoMasked":100},"NONE","This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.\n\nThe purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.",[106,112],{"label":107,"type":108,"description":109,"interventionNames":110},"High-flow oxygen therapy","EXPERIMENTAL","Intervention arm",[111],"Device: Added high-flow oxygen therapy",{"label":113,"type":114,"description":115,"interventionNames":116},"Low-flow oxygen therapy","ACTIVE_COMPARATOR","Comparison arm",[117],"Other: Standard care",[119,124],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":100},"DEVICE","Added high-flow oxygen therapy","Added high-flow oxygen therapy using the device Lumis HFT during nighttime and at the patient's discretion daytime, with the usual care (low-flow oxygen therapy) the rest of the time.",[107],{"type":6,"name":125,"description":126,"armGroupLabels":127,"otherNames":100},"Standard care","Standard care with low-flow oxygen therapy in accordance with clinical routine.",[113],[129],{"name":130,"affiliation":5,"role":131},"Magnus Ekström, MD, PhD","PRINCIPAL_INVESTIGATOR",[133],{"name":130,"role":134,"phone":135,"phoneExt":136,"email":137},"CONTACT","0455731000","+46","magnus.ekstrom@med.lu.se",[139,155],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"Research Unit, Blekinge University of Technology","RECRUITING","Karlskrona","Blekinge County","37185","Sweden","SE",{"type":148,"coordinates":149},"Point",[150,151],15.58661,56.16156,{"lat":151,"lon":150},[154],{"name":130,"role":134,"phone":100,"phoneExt":100,"email":137},{"facility":156,"status":141,"city":157,"state":100,"zip":158,"country":145,"countryCode":146,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Department of Heart, Lung and Clinical Physiology, Örebro University Hospital","Örebro","70185",{"type":148,"coordinates":160},[161,162],15.2066,59.27412,{"lat":162,"lon":161},[165],{"name":166,"role":134,"phone":100,"phoneExt":100,"email":100},"Josefin Sundh, MD, PhD",{"type":131,"investigatorFullName":168,"investigatorTitle":169,"investigatorAffiliation":5,"oldNameTitle":100,"oldOrganization":100},"Magnus Ekström","Associate Professor, Senior Lecturer",[171,173,176,178,180,182,184,186,188,190,192,195,197],{"name":172,"class":6},"Uppsala University Hospital",{"name":174,"class":175},"Region Stockholm","OTHER_GOV",{"name":177,"class":6},"Region Örebro County",{"name":179,"class":6},"Blekinge County Council Hospital",{"name":181,"class":6},"Blekinge Institute of Technology",{"name":183,"class":6},"Lund University",{"name":185,"class":6},"Region Östergötland",{"name":187,"class":175},"Vastra Gotaland Region",{"name":189,"class":175},"Region Västerbotten",{"name":191,"class":6},"Landstinget i Värmland",{"name":193,"class":194},"ResMed","INDUSTRY",{"name":196,"class":6},"Swedish Heart Lung Foundation",{"name":198,"class":175},"The Swedish Research Council","100535097",false,"NCT06247397","Effect of HIgh-flow Therapy in Long-term Oxygen Therapy","Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial","HILOT","Inclusion Criteria:\n\n* Age 40 years or older\n* Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox\n* COPD or ILD as main underlying reason for LTOT\n* Oxygen concentrator as stationary oxygen source in the home including night-time\n* Body mass index (BMI) \\\u003C 35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Current or previous treatment with home HFOT\n* Current treatment with home mechanical ventilation\n* Current treatment with home CPAP\n* Hospitalized during the last 2 weeks\n* Current smoking or contact with flames\n* Self-reported average use of the LTOT \\\u003C 15h per day (24 hours)\n* PaCO2 (breathing air at rest) \\> 8 kPa\n* Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)\n* Inability to participate in the study procedures (as judged by the staff)\n* Not eligible for continuing LTOT due to other reason (as judged by the staff)\n* Expected survival less than 3 months (as judged by the staff)","ALL","18 Years",{"count":209,"type":210},310,"ESTIMATED","INTERVENTIONAL",[213],"NA","This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).",[216,217,218],"Chronic Obstructive Pulmonary Disease Severe","Interstitial Lung Disease","Chronic Respiratory Failure With Hypoxia","2025-05-15",{"date":221,"type":222},"2025-05-21","ACTUAL",{"date":224,"type":222},"2024-06-10",{"date":226,"type":210},"2028-12",{"name":5,"class":6},2]