[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657991":3},{"organization":4,"outcomesModule":7,"designInfo":126,"detailedDescription":133,"studyPopulation":129,"armGroups":134,"interventions":145,"overallOfficials":155,"centralContacts":165,"locations":174,"responsibleParty":192,"collaborators":129,"id":194,"slug":195,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":196,"sex":201,"minAge":202,"maxAge":129,"enrollmentInfo":203,"targetDuration":129,"studyType":206,"phases":207,"briefSummary":210,"conditions":211,"keywords":215,"overallStatus":226,"whyStopped":129,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Woolcock Institute of Medical Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Breathing Disturbance Index (BDI)","BDI is the primary severity metric of OSA in the trial which is measured by the number of breathing disturbances per hour of sleep. This is measured using contactless mattress-based OSA monitors (SleepTracker-AI) that can automatically and reliably measure true OSA alleviation every night for the entire period of sleep.","The mean BDI measured over 28 nights of monitoring is calculated for baseline (Weeks -4 to 0) and follow-up (Weeks 48 to 52)",[14,18,22,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Hypoxia - Oxygen Desaturation Index (ODI 3%)","ODI 3% is calculated as the number of oxygen desaturation events ≥3% per hour as a percentage of time in bed, estimated using at-home oximetry (RingConn Gen 2).","ODI 3% will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12month follow-up.",{"measure":19,"description":20,"timeFrame":21},"Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a Score","The PROMIS Sleep-Related Impairment Short Form 8a Score is used to assess participant-reported levels of alertness, sleepiness, and tiredness and the functional impairments associated with sleep problems or reduced alertness over the past 7 days.","Collected at Baseline and 3,6,9 and 12 months.",{"measure":23,"description":24,"timeFrame":21},"Epworth Sleepiness Scale (ESS)","Subjective sleepiness scored out of 24 measured using an 8-item questionnaire.",{"measure":26,"description":27,"timeFrame":28},"Ambulatory Blood Pressure - Sleep Systolic Blood Pressure (SBP)","Sleep SBP is measured hourly, using an ambulatory blood pressure monitor, for a self-reported sleep period.","Baseline and Week 52",{"measure":30,"description":31,"timeFrame":32},"Cardiometabolic Fasted Blood Markers - Low-Density Lipoproteins (LDL)","Low-density lipoproteins are measured from fasted venous blood.","Screening and Week 52",{"measure":34,"description":35,"timeFrame":32},"Cardiometabolic Fasted Blood Markers - HbA1c","HbA1c, or glycated haemoglobin, assesses long-term glycaemic control. It is measured from fasted venous blood.",[37,41,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,93,96,99,102,105,108,112,116,119,122],{"measure":38,"description":39,"timeFrame":40},"Hypoxic Burden","This is an oximetry-derived measurement using established algorithms. Hypoxic burden measures are quantified from nightly at-home oximetry acquired using an oximeter device (RingConn Gen 2).","The mean nightly hypoxic burden measured over 7-10 nights of monitoring is calculated for baseline and 12 month follow-up.",{"measure":42,"description":43,"timeFrame":44},"Short Form Functional Outcomes of Sleep Questionnaire (FOSQ-10)","The FOSQ-10 is used to assess the impact of sleep disorders\u002Fexcessive sleepiness on daily functioning.","Baseline and 3, 6, 9 and 12 months.",{"measure":46,"description":47,"timeFrame":32},"Cardiometabolic Fasted Blood Markers - Glucose","Glucose is measured from fasted venous blood.",{"measure":49,"description":50,"timeFrame":32},"Cardiometabolic Fasted Blood Markers - Triglycerides [TAG]","Triglycerides are measured from fasted venous blood.",{"measure":52,"description":53,"timeFrame":32},"Cardiometabolic Fasted Blood Markers - High-Density Lipoproteins (HDL)","High-density lipoproteins are measured from fasted venous blood.",{"measure":55,"description":56,"timeFrame":32},"Cardiometabolic Fasted Blood Markers - Total Cholesterol","Total cholesterol is measured from fasted venous blood.",{"measure":58,"description":59,"timeFrame":28},"Ambulatory Blood Pressure - Sleep Diastolic Blood Pressure (DBP)","Sleep DBP is measured hourly over 24 hours using an ambulatory blood pressure monitor, segmented for a self-reported sleep period.",{"measure":61,"description":62,"timeFrame":28},"Ambulatory Blood Pressure - Wake Systolic Blood Pressure (SBP)","Wake SBP is measured hourly over 24 hours using an ambulatory blood pressure monitor, segmented for a self-reported wake period.",{"measure":64,"description":65,"timeFrame":28},"Ambulatory Blood Pressure - Wake Diastolic Blood Pressure (DBP)","Wake DBP is measured hourly over 24 hours using an ambulatory blood pressure monitor, segmented for a self-reported wake period.",{"measure":67,"description":68,"timeFrame":28},"Ambulatory Blood Pressure - 24-hour Mean Arterial Pressure (MAP)","24-hour MAP is calculated hourly over 24 hours using an ambulatory blood pressure monitor. MAP = DBP + (SBP - DBP)\u002F3",{"measure":70,"description":71,"timeFrame":28},"Office Blood Pressure - Systolic Blood Pressure (SBP)","SBP is measured using an automated blood pressure machine after sitting quietly for 5 minutes.",{"measure":73,"description":74,"timeFrame":28},"Office Blood Pressure - Diastolic Blood Pressure (DBP)","DBP is measured using an automated blood pressure machine after sitting quietly for 5 minutes.",{"measure":76,"description":77,"timeFrame":28},"Anthropometry - Body Mass Index (kg\u002Fm^2)","BMI is calculated as weight in kilograms, divided by height measured in metres squared.",{"measure":79,"description":80,"timeFrame":28},"Anthropometry - Weight (kg)","Weight is measured in kilograms.",{"measure":82,"description":83,"timeFrame":28},"Anthropometry - Body Weight (% change)","Change in Weight is calculated as a percentage of change from baseline to 52-weeks.",{"measure":85,"description":86,"timeFrame":28},"Anthropometry - Waist Circumference","Waist circumference is measured in centimetres, using a tape measure positioned in line with the superior iliac crest of the hip.",{"measure":88,"description":89,"timeFrame":28},"Anthropometry - Neck Circumference","Neck circumference is measured in centimetres, using a tape measure positioned inferior to the laryngeal prominence.",{"measure":91,"description":92,"timeFrame":28},"CAmbridge Neuropsychological Test Automated Battery (CANTAB) Multitasking Test","The Multitasking Test is used to assess executive functioning and cued attentional set shifting.",{"measure":94,"description":95,"timeFrame":28},"CANTAB Spatial Working Memory Task","The Spatial Working Memory Task is used to assess working memory and strategy and is applicable in the assessment of general cognitive function.",{"measure":97,"description":98,"timeFrame":28},"Psychomotor Vigilance Task (PVT)","The PVT is used to assess a participant's level of alertness.",{"measure":100,"description":101,"timeFrame":28},"Blood-Based Neurodegeneration Biomarkers - Amyloid Beta","Amyloid Beta, a peptide associated with Alzheimer's disease, is measured from fasted venous blood.",{"measure":103,"description":104,"timeFrame":28},"Blood-Based Neurodegeneration Biomarkers - Phosphorylated Tau","Phosphorylated Tau \\[p-Tau-217\\], a tau protein with added phosphate groups, is measured from fasted venous blood.",{"measure":106,"description":107,"timeFrame":28},"Blood-Based Neurodegeneration Biomarkers - Glial Fibrillary Acidic Protein (GFAP)","GFAP, a structural protein found in astrocytic cells, is measured from fasted venous blood.",{"measure":109,"description":110,"timeFrame":111},"Hypoxia - Time Spent With SpO2\u003C88%","Time spent with SpO2\\\u003C88% is calculated as the time spent with oxygen saturation below 88% as a percentage of time in bed, estimated using at-home oximetry.","Hypoxia outcomes will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12months.",{"measure":113,"description":114,"timeFrame":115},"Hypoxia - Minimum SpO2","Minimum SpO2 is calculated as the minimum oxygen saturation reached during time in bed, estimated using at-home oximetry.","Hypoxia outcomes will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12 month follow-up",{"measure":117,"description":118,"timeFrame":115},"Hypoxia - Average Desaturation","Average desaturation is calculated as the mean of all desaturation events \\>=3% during time in bed, estimated using at-home oximetry.",{"measure":10,"description":120,"timeFrame":121},"BDI is measured by the number of breathing disturbances per hour of sleep using contactless mattress-based OSA monitors (SleepTracker-AI).","Nightly for 12-month treatment duration.",{"measure":123,"description":124,"timeFrame":125},"Anthropometry - Weight (Self-Measured)","Weight (kg) - self-measured at home","At Baseline, 3, 6, and 9 months",{"allocation":127,"interventionModel":128,"interventionModelDescription":129,"primaryPurpose":130,"observationalModel":129,"timePerspective":129,"maskingInfo":131},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":132,"maskingDescription":129,"whoMasked":129},"NONE","The TIRZE-PAP study is a parallel randomised superiority trial comparing weight loss with weekly tirzepatide (15mg or the maximum tolerated dose) versus CPAP, in 256 people with moderate-severe OSA (AHI≥15\u002Fhr) and overweight or obesity (BMI: ≥27kg\u002Fm2). Participants allocated to CPAP will receive therapy as per usual care by their treating physician. Participants allocated to tirzepatide will undergo a 20-week stepped titration with a monthly increase of dose to a maximum 15mg (or maximum tolerated) by week 20. Outcomes will be collected over two 28-day periods commencing at baseline (pre-intervention weeks -4 to 0) and at follow-up (post-intervention weeks 48 to 52).",[135,140],{"label":136,"type":137,"description":129,"interventionNames":138},"Continuous Positive Airway Pressure (CPAP)","ACTIVE_COMPARATOR",[139],"Device: Continuous Positive Airway Pressure",{"label":141,"type":142,"description":129,"interventionNames":143},"Tirzepatide","EXPERIMENTAL",[144],"Drug: Tirzepatide",[146,151],{"type":147,"name":148,"description":149,"armGroupLabels":150,"otherNames":129},"DEVICE","Continuous Positive Airway Pressure","Participants allocated to CPAP will be managed by their caring sleep physician as per their normal practice. Participants may also be counselled on losing weight with diet and exercise as per usual practice.",[136],{"type":152,"name":141,"description":153,"armGroupLabels":154,"otherNames":129},"DRUG","Patients allocated to weight loss with tirzepatide will be managed by the study dietitian. The tirzepatide formulation is administered subcutaneously once weekly using single-use injection pens. Participants will undergo a 20-week dose escalation phase followed by a dose maintenance phase for the remainder of the 12-month study period.",[141],[156,160,162],{"name":157,"affiliation":158,"role":159},"Craig Phillips","Woolcock Institute of Medical Research and Macquarie Medical School, Macquarie University, Sydney, NSW, Australia","PRINCIPAL_INVESTIGATOR",{"name":161,"affiliation":158,"role":159},"Ron Grunstein",{"name":163,"affiliation":5,"role":164},"Camilla Hoyos, PhD","STUDY_CHAIR",[166,171],{"name":167,"role":168,"phone":169,"phoneExt":129,"email":170},"Craig Phillips, PhD","CONTACT","02 9805 3000","c.phillips@mq.edu.au",{"name":172,"role":168,"phone":129,"phoneExt":129,"email":173},"Julia Chapman, PhD","julia.chapman@woolcock.org.au",[175],{"facility":5,"status":129,"city":176,"state":177,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":186,"contacts":187},"Macquarie Park","New South Wales","2113","Australia","AU",{"type":182,"coordinates":183},"Point",[184,185],151.12757,-33.78105,{"lat":185,"lon":184},[188],{"name":189,"role":168,"phone":190,"phoneExt":129,"email":191},"Greg Kaplan, PhD","+61 2 9805 3232","grigori.kaplan@woolcock.org.au",{"type":159,"investigatorFullName":157,"investigatorTitle":193,"investigatorAffiliation":5,"oldNameTitle":129,"oldOrganization":129},"Associate Professor","100657991","phase-2-tirzepatide-versus-positive-airway-pressure-for-the-treatment-of-obstructive-sleep-apnoea-a-randomised-comparative-effectiveness-trial-100657991",false,"NCT07846865","Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial","TIRZE-PAP","Inclusion Criteria:\n\n* Females and Males aged ≥ 18 years at the time of signing informed consent\n* Moderate-severe OSA defined as an AHI ≥ 15\u002Fhr determined from a Type 1 or 2 sleep study conducted within the previous 12 months with a clinician recommendation for CPAP therapy.\n* Moderate overweight or obesity defined as BMI ≥ 27 kg\u002Fm2. (Adjusted to BMI ≥ 25 kg\u002Fm2 for Asian populations as per WHO guidelines (WHO Expert Consultation (2004))\n* No contraindication to tirzepatide use as per Australian Product Information\n* Home internet access to enable cloud storage of SleepTracker-AI in-home BDI.\n* Fluent English literacy and able to provide informed consent.\n\nExclusion Criteria:\n\nOSA or other respiratory related criteria:\n\n* Respiratory failure including obesity hypoventilation syndrome (OHS) or daytime hypercapnia or moderate-severe chronic obstructive pulmonary disease (COPD) with FEV1\u002FFVC ratio\\\u003C0.7 and FEV1\\\u003C80% predicted (GOLD criteria).\n* Driver occupation with excessive sleepiness (Epworth Sleepiness Scale \\>=16) or sleepiness-related motor vehicle accident or near accident within 12 months prior to enrolment\n* Current or prior (≤3 months) OSA treatment with mechanical therapy (CPAP, MAS, Positional)\n* \\>50% respiratory events with Cheyne-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA)\n* Relative or absolute contraindication to CPAP including chronic cranial injury; recurrent pneumothorax; indication for oral-pharyngeal surgery, significant craniofacial abnormalities that may affect breathing, or are unwilling to use CPAP\n* Any previous or planned surgery for OSA or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing (NB: Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion)\n\nGlycaemia related criteria:\n\n* HbA1c ≥ 48 mmol\u002Fmol (6.5%) at screening\n* Type 1 or type 2 diabetes mellitus\n* Treatment with glucose-lowering agent(s) within 90 days before screening\n* Treatment with a GLP-1 receptor agonist within 90 days before screening\n\nObesity related criteria:\n\n* A self-reported change in body weight \\>5 kg or \\>5% within 90 days before baseline\n* Treatment with medication for the indication of obesity within 90 days before baseline and\u002For currently enrolled in a weight loss program\n\nOther criteria:\n\n* Pregnancy\u002Fbreast feeding or planning a pregnancy during the trial period\n* Relative or absolute contraindication to tirzepatide including needle phobia","ALL","18 Years",{"count":204,"type":205},256,"ESTIMATED","INTERVENTIONAL",[208,209],"PHASE2","PHASE3","When used, continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnea (OSA), a condition that is mainly caused by overweight and obesity. However, CPAP is plagued by poor adherence and high rates of discontinued use leaving most patients undertreated and at risk of serious health complications. This study aims to test whether new effective weight loss pharmacotherapy is superior to CPAP for alleviating OSA and improving health outcomes.",[212,213,214],"Sleep Apnoea","Obesity & Overweight","Sleep Apnea Syndrome, Obstructive",[148,141,212,216,217,218,219,220,221,222,223,224,225],"Clinical Trial","weight loss","GLP1","Mounjaro","OSA","CPAP","comparative effectiveness","randomized","sleep apnea","GIP","NOT_YET_RECRUITING","2026-09-22",{"date":229,"type":230},"2026-09-29","ACTUAL",{"date":232,"type":205},"2026-10-01",{"date":234,"type":205},"2028-12-01",{"name":5,"class":6},1]