[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465006":3},{"organization":4,"outcomesModule":7,"designInfo":112,"detailedDescription":119,"studyPopulation":115,"armGroups":120,"interventions":131,"overallOfficials":137,"centralContacts":141,"locations":147,"responsibleParty":185,"collaborators":115,"id":187,"slug":115,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":115,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":194,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":115,"studyType":200,"phases":201,"briefSummary":203,"conditions":204,"keywords":115,"overallStatus":207,"whyStopped":115,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"Woolcock Institute of Medical Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":99},[9],{"measure":10,"description":11,"timeFrame":12},"Mean 24 hour glucose difference between the CPAP on and CPAP off conditions","Average 24 hour glucose difference between CPAP on and CPAP off conditions","2 weeks",[14,17,20,23,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,93,96],{"measure":15,"description":16,"timeFrame":12},"Mean daytime glucose difference between the CPAP on and CPAP off conditions","Mean Daytime (6:00 AM - 10:00 PM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":18,"description":19,"timeFrame":12},"Mean night time glucose","Mean Night-time (10:00 PM - 6:00 AM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":21,"description":22,"timeFrame":12},"Glucose tolerance","Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load administered twice during each two-week observation period using a CGM",{"measure":24,"description":25,"timeFrame":26},"Coefficient of Variation","Percentage CV intraday (i.e. within 24h) and interday (i.e. over multiple days) between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.","2 Weeks",{"measure":28,"description":29,"timeFrame":26},"SD of Mean Glucose","SD of Mean Glucose (daily) during the CPAP on and CPAP off conditions during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":31,"description":32,"timeFrame":26},"Time in Range (TIR)","Percentage of TIR (3.9-10.0 mmol\u002FL) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":34,"description":35,"timeFrame":26},"Time Below Range (TBR)","Percentage of TBR (3.9 mmol\u002FL including readings of \\\u003C3 .0 mmol\u002FL) during the the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":37,"description":38,"timeFrame":26},"Time below Range \u003C3.0 mmol\u002FL","Percentage of TBR \\\u003C3.0 mmol\u002FL (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":40,"description":41,"timeFrame":26},"Time Above Range (TAR)","Percentage of TAR (\\>10.0 mmol\u002FL, including readings \\>13.9 mmol\u002FL) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":43,"description":44,"timeFrame":26},"Time Above Range >13.9 mmol\u002FL","Percentage of TAR \\>13.9 mmol\u002FL (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":46,"description":47,"timeFrame":26},"Time in Tight Range (TITR)","Percentage of TITR (3.9-7.8 mmol\u002FL) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":49,"description":50,"timeFrame":26},"Change in Glucose Management Indicator","Absolute main change in mmol\u002FL or percentage during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":52,"description":53,"timeFrame":26},"Extended hypoglycaemic event rate","Number of events with sensor glucose \\\u003C3.9 mmol\u002FL lasting at least 120 min, event ends when glucose returns to at least 3.9 mmol\u002FL for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":55,"description":56,"timeFrame":26},"Extended hyperglycaemic event","Number of events with sensor glucose \\>13.9 mmol\u002FL lasting at least 120 min; event ends when glucose returns to 10 mmol\u002FL or less for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":58,"description":59,"timeFrame":26},"TIR >70%","Proportion of participants with TIR 3.9-10.0 mmol\u002FL for \\>70% of the day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":61,"description":62,"timeFrame":26},"TIR improvement at least 5%","Proportion of participants with TIR 3.9-10.0 mmol\u002FL with at least a 5% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":64,"description":65,"timeFrame":26},"TIR improvement at least 10%","Proportion of participants with TIR 3.9-10.0 mmol\u002FL with at least a 10% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":67,"description":68,"timeFrame":26},"TBR \u003C3.9 mmol\u002FL \u003C4%","Proportion of participants with TBR \\\u003C3.9 mmol\u002FL for \\\u003C4% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":70,"description":71,"timeFrame":26},"TBR \u003C3.0 mmol\u002FL \u003C1%","Proportion of participants with TBR \\\u003C3.0 mmol\u002FL for \\\u003C1% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":73,"description":74,"timeFrame":26},"TAR >10.0 mmol\u002FL >25%","Proportion of participants with a TAR \\>10.0 mmol\u002FL for \\\u003C25% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":76,"description":77,"timeFrame":26},"TAR >13.9 mmol\u002FL \u003C5%","Proportion of participants with TAR \\>13.9 mmol\u002FL for \\\u003C5% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":79,"description":80,"timeFrame":26},"Hypoglycaemia","Number of times CGM sensor values are \\\u003C3.9 mmol\u002FL (including readings of \\\u003C3.0 mmol\u002FL) for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol\u002FL.",{"measure":82,"description":83,"timeFrame":26},"Hypoglycaemia Alert Value (Level 1)","Number of times CGM sensor values are 3.0-3.9 mmol\u002FL for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol\u002FL.",{"measure":85,"description":86,"timeFrame":26},"Clinically Significant Hypoglycaemia (Level 2)","Number of times CGM sensor values are \\\u003C3.0 mmol\u002FL for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.0 mmol\u002FL.",{"measure":88,"description":89,"timeFrame":26},"Extended Hypoglycaemia","Number of times CGM sensor values are \\\u003C3.9 mmol\u002FL for at least 120 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":91,"description":92,"timeFrame":26},"High Glucose Level (Level 1)","Number of times CGM sensor values are 10.1-13.9 mmol\u002FL for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 10 mmol\u002FL.",{"measure":94,"description":95,"timeFrame":26},"Very High Glucose (Level 2)","Number of times CGM sensor values are \\>13.9 mmol\u002FL for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 13.9 mmol\u002FL.",{"measure":97,"description":98,"timeFrame":26},"Extended Hyperglycaemia","Number of times CGM sensor values are \\>13.9 mmol\u002FL for at least 90 consecutive minutes within a 120-minute period during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",[100,103,106,109],{"measure":101,"description":102,"timeFrame":26},"TIR Improvement >10% and \u003C0.5% increase in TBR \u003C3.0 mmol\u002FL","Proportion of participants with \\>10% improvement in percentage of TIR 3.9-10.0 mmol\u002FL without an increase in the TBR \\\u003C3.0 mmol\u002FL of \\>0.5% during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":104,"description":105,"timeFrame":26},"Mean Glucose \u003C8.6 mmol\u002FL and \u003C1% TBR \u003C3.0 mmol\u002FL","Proportion of participants with Mean Glucose \\\u003C8.6 mmol\u002FL and \\\u003C 1% TBR \\\u003C3.0 mmol\u002FL during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":107,"description":108,"timeFrame":26},"TIR >70% and \u003C1% TBR \u003C3.9 mmol\u002FL","Proportion of participants with \\>70% TIR 3.9-10.0mmol\u002FL and \\\u003C4% TBR \\\u003C3.9 mmol\u002FL during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"measure":110,"description":111,"timeFrame":26},"TIR >70% and \u003C 1% TBR \u003C3.0 mmol\u002FL","Proportion of participants with \\>70% TIR 3.9-10.0 mmol\u002FL and \\\u003C1% TBR \\\u003C3.0 mmol\u002FL during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.",{"allocation":113,"interventionModel":114,"interventionModelDescription":115,"primaryPurpose":116,"observationalModel":115,"timePerspective":115,"maskingInfo":117},"NON_RANDOMIZED","SEQUENTIAL",null,"TREATMENT",{"masking":118,"maskingDescription":115,"whoMasked":115},"NONE","Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP. Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.",[121,125],{"label":122,"type":123,"description":124,"interventionNames":115},"CPAP off condition","NO_INTERVENTION","Participants will be monitored for a two-week period prior to commencing CPAP.",{"label":126,"type":127,"description":128,"interventionNames":129},"CPAP on condition","EXPERIMENTAL","Participants will be monitored for a two-week period at least four weeks following commencement of CPAP.",[130],"Device: CPAP",[132],{"type":133,"name":134,"description":135,"armGroupLabels":136,"otherNames":115},"DEVICE","CPAP","A positive CPAP intervention",[126],[138],{"name":139,"affiliation":5,"role":140},"Craig L Phillips, PhD","PRINCIPAL_INVESTIGATOR",[142],{"name":143,"role":144,"phone":145,"phoneExt":115,"email":146},"David J Sherring, MBBS, DClinD","CONTACT","0407886698","dshe7670@uni.sydney.edu.au",[148,168],{"facility":149,"status":115,"city":150,"state":151,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":160,"contacts":161},"Royal Prince Alfred Hospital","Camperdown","New South Wales","2050","Australia","AU",{"type":156,"coordinates":157},"Point",[158,159],151.17642,-33.88965,{"lat":159,"lon":158},[162,166],{"name":163,"role":144,"phone":164,"phoneExt":115,"email":165},"Estelle Ali","+61 468805641","estelle.ali@health.nsw.gov.au",{"name":167,"role":140,"phone":115,"phoneExt":115,"email":115},"Professor Brendon Yee",{"facility":5,"status":115,"city":169,"state":151,"zip":170,"country":153,"countryCode":154,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Macquarie Park","2113",{"type":156,"coordinates":172},[173,174],151.12757,-33.78105,{"lat":174,"lon":173},[177,181,183],{"name":178,"role":144,"phone":179,"phoneExt":115,"email":180},"Grigori Kaplan, PhD","+61 9114 0412","grigori.kaplan@sydney.edu.au",{"name":182,"role":140,"phone":115,"phoneExt":115,"email":115},"Craig Phillips, PhD",{"name":184,"role":140,"phone":115,"phoneExt":115,"email":115},"Brendon Yee, PhD FRACP",{"type":186,"investigatorFullName":115,"investigatorTitle":115,"investigatorAffiliation":115,"oldNameTitle":115,"oldOrganization":115},"SPONSOR","100465006",false,"NCT05335083","CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects","The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - An Observational Study","Inclusion Criteria:\n\n1. Community dwelling adult males and females aged 18-65 years\n2. Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15\u002Fhr within the past 60 months\n3. Able to give written informed consent\n4. Proficient in English\n\n6\\. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (\\\u003C3 months) findings:\n\n1. Fasting glucose with a BGL \\\u003C7.0 mmol\u002FL\n2. Glucose tolerance with a 2-hour BGL of \\\u003C 11.1 mmol\u002FL after a formal 75g Oral Glucose Tolerance Test (OGTT)\n3. HbA1C of ≤ 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.\n\nExclusion Criteria:\n\n1. Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)\n2. Severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study.\n3. Regular (\\>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)\n4. Regular night shift work or travel overseas within the last 2 weeks\n5. Sleep physician has advised against CPAP withdrawal\n6. Pregnancy\n7. Active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (\\>300 mg a day) or recent (in the past month) use of illicit drugs\n8. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)\n9. Current or recent (\\\u003C3 months) use of hypoglycaemic agents\n10. Undergoing a weight loss programme\n11. Contraindications for use of the FreeStyle Libre Pro Sensor. E.g. Known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.",true,"ALL","18 Years","65 Years",{"count":198,"type":199},100,"ESTIMATED","INTERVENTIONAL",[202],"NA","The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.",[205,206],"Obstructive Sleep Apnea","Pre-diabetes","NOT_YET_RECRUITING","2025-03-25",{"date":210,"type":211},"2025-04-01","ACTUAL",{"date":213,"type":199},"2025-07-01",{"date":215,"type":199},"2027-02-28",{"name":5,"class":6},2]