[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514439":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":48,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":42,"enrollmentInfo":86,"targetDuration":42,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Flinders University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reboxetine","EXPERIMENTAL","7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.",[13],"Drug: Reboxetine 4 MG Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Reboxetine 4 MG Oral Tablet","7 nightly doses (4mg) to commence after surgery.",[9],[27],"Edronax",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"7 nightly doses to commence after surgery.",[15],[32],"Sugar pill",[34],{"name":35,"affiliation":5,"role":36},"Danny J. Eckert, PhD","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Emma Thomas","CONTACT","+61882012912",null,"ethomas@flinders.edu.au",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Carolin Tran","+61874219873","carolin.tran@flinders.edu.au",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Flinders, Private and Public Hospitals and Flinders University","RECRUITING","Bedford Park","South Australia","5042","Australia","AU",{"type":58,"coordinates":59},"Point",[60,61],138.56815,-35.02204,{"lat":61,"lon":60},[64,66,68],{"name":39,"role":40,"phone":65,"phoneExt":42,"email":43},"+61 8 8201 2912",{"name":45,"role":40,"phone":67,"phoneExt":42,"email":47},"+61 8 7421 9873",{"name":35,"role":40,"phone":42,"phoneExt":42,"email":42},{"type":36,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Professor Danny Eckert","Director, Adelaide Institute for Sleep Health",[73],{"name":74,"class":75},"Flinders Medical Centre","OTHER_GOV","100514439","phase-2-reboxetine-for-sleep-apnoea-after-ent-surgery-100514439",false,"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","ALL","18 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","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.",[94],"Sleep Apnea, Obstructive",[96,97,98,99,100,101,102,103,104],"sleep apnea, obstructive","upper airway surgery","ENT surgery","reboxetine","noradrenaline reuptake inhibitor","randomised","feasibility","placebo","double-blind","2024-10-02",{"date":107,"type":108},"2024-10-03","ACTUAL",{"date":110,"type":108},"2023-08-10",{"date":112,"type":88},"2025-07",{"name":5,"class":6},1]