[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440175":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":27,"locations":35,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Acute Hypercapnic Respiratory Failure patients with Sleep Disorders",null,[12],"Device: High-flow nasal cannula therapy",{"label":14,"type":10,"description":14,"interventionNames":15},"Acute Hypercapnic Respiratory Failure patients without Sleep Disorders",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DEVICE","High-flow nasal cannula therapy","High-flow nasal cannula therapy (HFNC) (from 25 - 60 L\u002Fmin based on patient's tolerance) will be used in 21 participants during one additional sleep study to investigate its acute impact on reducing sleep abnormalities. Inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.",[9,14],[23],{"name":24,"affiliation":25,"role":26},"Laurent Brochard, MD, PhD","Unity Health Toronto - St. Michael's Hospital","PRINCIPAL_INVESTIGATOR",[28,32],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","416-864-5686","Laurent.Brochard@unityhealth.to",{"name":33,"role":29,"phone":10,"phoneExt":10,"email":34},"Antenor Rodrigues, PT","Antenor.Rodrigues@unityhealth.to",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"St. Michael's Hospital","RECRUITING","Toronto","Ontario","M5B 1W8","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-79.39864,43.70643,{"lat":48,"lon":47},[51,54,57],{"name":52,"role":29,"phone":53,"phoneExt":10,"email":10},"Laurent Brochard, MD, MD, HDR","4168645686",{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Antenor Rodrigues","SUB_INVESTIGATOR",{"name":58,"role":26,"phone":10,"phoneExt":10,"email":10},"Laurent Brochard",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100440175","the-simplify-project-100440175",false,"NCT05011877","The Simplify Project","A Strategy to Improve Management and Prolong LIFe Without Readmission for hYpercapnic Patients: The Simplify Project","SIMPLIFY","Inclusion Criteria:\n\n* Adult patients requiring an unplanned hospitalization or emergency room visit due to an acute hypercapnic respiratory failure exacerbation (AHRF), not on home noninvasive or invasive ventilation, neuromuscular disease (e.g., spinal cord injury) or central nervous system disorders (e.g., cerebral vascular accident, Alzheimer), absence of tracheotomy, and non-morbidly obese.\n\nExclusion Criteria:\n\n* Patients with AHRF due to drug overdose\n* Ventilatory support (noninvasive or invasive ventilation) is needed before or during the sleep studies or if an acute deterioration (e.g., cerebral vascular accident, cardiac arrest) happens before or during the sleep studies.","ALL","18 Years",{"count":72,"type":73},50,"ESTIMATED","OBSERVATIONAL","The high frequency of unplanned hospital visits of patients with chronic hypercapnic respiratory failure (e.g., chronic obstructive pulmonary disease, obesity-related hypoventilation) constitutes a major public health problem. Most patients admitted for acute exacerbations (AHRF) have additional comorbidities, especially sleep disorders. Often untreated, sleep disorders contribute to multiple readmissions (≈70% at one year) and increase readmission costs. The investigators will: 1) identify these patients early during unplanned hospital admissions and perform sleep studies using EEG and oximetry before hospital discharge and two months after to compare sleep abnormalities in the two moments; 2) investigate the association between sleep abnormalities in the two sleep studies with clinical outcomes (1-year readmission and death); 3) investigate the acute effects of high-flow nasal cannula (HFNC) to treat sleep abnormalities as a simplified alternative. The investigators anticipate sleep abnormalities during the hospital stay and two months after discharge will be associated with poor clinical outcomes (readmission, death) and HFNC to acutely reduce sleep abnormalities.",[77],"Acute Hypercapnic Respiratory Failure",[77,79,80,81],"Patient Readmission","Mortality","Sleep Disorders, Intrinsic","2025-05-15",{"date":84,"type":85},"2025-05-20","ACTUAL",{"date":87,"type":85},"2021-09-01",{"date":89,"type":73},"2026-07-01",{"name":5,"class":6},1]