[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Flinders University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100587467","phase-2-effects-of-eszopiclone-and-lemborexant-in-people-with-osa-with-a-low-arousal-threshold-who-have-difficulty-sleeping-100587467",false,"NCT06928766","Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping","Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.","ELOSA","Inclusion Criteria:\n\n* Moderate or more difficulty \"staying or initiating asleep\" score on the Insomnia Severity Index questionnaire\n* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 10 events\u002Fhour\n* Low arousal respiratory threshold OSA endotype\n* BMI ≤35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Concomitant medications that interact or are contraindicated with eszopiclone, zopiclone, and Lemborexant\n* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology\n* Current pregnancy or breast-feeding\n* Current or recent other medical conditions likely to affect results or safety","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches.\n\nPeople get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold).\n\nAccordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).",[27],"OSA - Obstructive Sleep Apnea",[29,30,31],"sleep disordered breathing","arousal","COMISA","NOT_YET_RECRUITING","2025-04-15",{"date":35,"type":36},"2025-04-18","ACTUAL",{"date":38,"type":21},"2025-05-01",{"date":40,"type":21},"2027-06-30",{"name":42,"class":43},"Flinders University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":44},"100514439","phase-2-reboxetine-for-sleep-apnoea-after-ent-surgery-100514439","NCT05978505","Reboxetine for Sleep Apnoea After ENT Surgery","Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study","RENTOSA","Inclusion Criteria:\n\n* Age \\>18 years\n* Undergoing elective upper airway surgery\n* History of obstructive sleep apnoea (OSA)\n\nExclusion Criteria:\n\n* Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure)\n* History of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia\n* Poorly controlled hypertension\n* Epilepsy\n* History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V or International Classification of Disease 10th edition criteria\n* History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation\n* Narrow angle glaucoma",{"count":54,"type":21},20,[24],"This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.",[58],"Sleep Apnea, Obstructive",[60,61,62,63,64,65,66,67,68],"sleep apnea, obstructive","upper airway surgery","ENT surgery","reboxetine","noradrenaline reuptake inhibitor","randomised","feasibility","placebo","double-blind","RECRUITING","2024-10-02",{"date":72,"type":36},"2024-10-03",{"date":74,"type":36},"2023-08-10",{"date":76,"type":21},"2025-07",{"name":42,"class":43},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100362020","cardiovascular-magnetic-resonance-guided-insertion-of-implantable-cardiac-defibrillator-in-dilated-cardiomyopathy-100362020","NCT03993730","Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy","CMR GUIDE DCM","Inclusion Criteria:\n\n* Age greater than\u002Fequal to 18 years old\n* Non-ischemic cardiomyopathy of dilated type\n* Left Ventricular Ejection Fraction \\\u003C 45%\n* Able and willing to comply with all pre, post and follow-up testing and requirements\n* On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers\n\nExclusion Criteria:\n\n1. Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)\n2. Hypertrophic Cardiomyopathy\n3. Cardiomyopathy related to sarcoidosis\n4. Arrhythmogenic Right Ventricular Dysplasia\n5. Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)\n6. Currently implanted permanent pacemaker and\u002For pacemaker\u002FICD lead\n7. Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy\n8. Contraindications to intravenous Gadolinium\n9. Severe renal insufficiency (eGFR\\\u003C 45mls\u002Fmin\u002F1.73m2 )\n10. New York Heart Association Heart Failure functional class IV\n11. Conditions associated with life expectancy \\\u003C1 year\n12. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception",{"count":86,"type":21},1880,[88],"NA","CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients.\n\nPatients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR).\n\n954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR).\n\nDevice and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.",[91,92,93],"Dilated Cardiomyopathy","Left Ventricular Systolic Dysfunction","Fibrosis Myocardial","2019-06-20",{"date":96,"type":36},"2019-06-21",{"date":98,"type":21},"2020-06",{"date":100,"type":21},"2026-06",{"name":42,"class":43},""]