[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514439":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":60,"studyPopulation":60,"armGroups":69,"interventions":82,"overallOfficials":95,"centralContacts":99,"locations":109,"responsibleParty":130,"collaborators":133,"id":137,"slug":60,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":138,"sex":144,"minAge":145,"maxAge":60,"enrollmentInfo":146,"targetDuration":60,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":112,"whyStopped":60,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Flinders University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":52},[9,13],{"measure":10,"description":11,"timeFrame":12},"Treatment protocol adherence","The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.","7 days",{"measure":14,"description":15,"timeFrame":16},"Data capture efficiency","The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.","14 days",[18,21,24,27,30,33,36,39,42,45,48],{"measure":19,"description":20,"timeFrame":16},"Oxygen desaturation index (ODI)","Number of times per hour that a participant has a drop in blood oxygen levels during sleep",{"measure":22,"description":23,"timeFrame":16},"nadir SpO2","The lowest oxygen saturation value the patient drops to in a night.",{"measure":25,"description":26,"timeFrame":16},"Time spent below 90% SpO2","The total amount of time per night for which oxygen saturation falls below 90%.",{"measure":28,"description":29,"timeFrame":16},"mean SpO2","Average nightly oxygen level",{"measure":31,"description":32,"timeFrame":16},"Sleep duration","Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.",{"measure":34,"description":35,"timeFrame":16},"Sleep efficiency (%)","The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.",{"measure":37,"description":38,"timeFrame":16},"Daytime sleepiness","Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)",{"measure":40,"description":41,"timeFrame":16},"Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire","This questionnaire asks participants to rate their perceived sleep across 4 domains on a visual analog scale as follows: 1) getting to sleep, 2) quality of sleep, 3) Awake following sleep, 4) Behavior following wakening. Higher scores indicate better perceived sleep.",{"measure":43,"description":44,"timeFrame":16},"Insomnia Severity Score","A patient-reported measure of insomnia symptoms using the Insomnia Severity Index- A 28 point scale where 0 indicates no clinically significant insomnia and 28 indicates maximally severe clinical insomnia.",{"measure":46,"description":47,"timeFrame":16},"Apnoea-hypopnea hndex (AHI)","Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events\u002Fhour) between placebo and reboxetine",{"measure":49,"description":50,"timeFrame":51},"Study enrolment rate","The number of referred patients successfully enrolled into this feasibility study","12 months",[53],{"measure":54,"description":55,"timeFrame":16},"Reboxetine-related side effects","Documented via adverse-event forms.",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":6,"observationalModel":60,"timePerspective":60,"maskingInfo":61},"RANDOMIZED","CROSSOVER","Double-blind, randomized, placebo-controlled, cross-over study",null,{"masking":62,"maskingDescription":63,"whoMasked":64},"QUADRUPLE","Identical capsule for placebo and study drug prepared by study pharmacist",[65,66,67,68],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[70,76],{"label":71,"type":72,"description":73,"interventionNames":74},"Reboxetine","EXPERIMENTAL","7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.",[75],"Drug: Reboxetine 4 MG Oral Tablet",{"label":77,"type":78,"description":79,"interventionNames":80},"Placebo","PLACEBO_COMPARATOR","Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.",[81],"Drug: Placebo",[83,90],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"DRUG","Reboxetine 4 MG Oral Tablet","7 nightly doses (4mg) to commence after surgery.",[71],[89],"Edronax",{"type":84,"name":77,"description":91,"armGroupLabels":92,"otherNames":93},"7 nightly doses to commence after surgery.",[77],[94],"Sugar pill",[96],{"name":97,"affiliation":5,"role":98},"Danny J. Eckert, PhD","PRINCIPAL_INVESTIGATOR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":60,"email":104},"Emma Thomas","CONTACT","+61882012912","ethomas@flinders.edu.au",{"name":106,"role":102,"phone":107,"phoneExt":60,"email":108},"Carolin Tran","+61874219873","carolin.tran@flinders.edu.au",[110],{"facility":111,"status":112,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Flinders, Private and Public Hospitals and Flinders University","RECRUITING","Bedford Park","South Australia","5042","Australia","AU",{"type":119,"coordinates":120},"Point",[121,122],138.56815,-35.02204,{"lat":122,"lon":121},[125,127,129],{"name":101,"role":102,"phone":126,"phoneExt":60,"email":104},"+61 8 8201 2912",{"name":106,"role":102,"phone":128,"phoneExt":60,"email":108},"+61 8 7421 9873",{"name":97,"role":102,"phone":60,"phoneExt":60,"email":60},{"type":98,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Professor Danny Eckert","Director, Adelaide Institute for Sleep Health",[134],{"name":135,"class":136},"Flinders Medical Centre","OTHER_GOV","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":147,"type":148},20,"ESTIMATED","INTERVENTIONAL",[151],"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.",[154],"Sleep Apnea, Obstructive",[156,157,158,159,160,161,162,163,164],"sleep apnea, obstructive","upper airway surgery","ENT surgery","reboxetine","noradrenaline reuptake inhibitor","randomised","feasibility","placebo","double-blind","2024-10-02",{"date":167,"type":168},"2024-10-03","ACTUAL",{"date":170,"type":168},"2023-08-10",{"date":172,"type":148},"2025-07",{"name":5,"class":6},1]