[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639471":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":55,"centralContacts":59,"locations":70,"responsibleParty":89,"collaborators":64,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":64,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":64,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":119,"whyStopped":64,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,16,20,24],{"label":9,"type":6,"description":10,"interventionNames":11},"Sequence 1","HGNS+AtoOxy -\\> Placebo -\\> HGNS -\\> AtoOxy\n\nEach participant receives all four treatment conditions (\"periods\") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.",[12,13,14,15],"Other: Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy)","Device: Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition","Drug: Atomoxetine-plus-oxybutynin (80\u002F5 mg) (AtoOxy), active comparator condition","Drug: Placebo; placebo comparator condition",{"label":17,"type":6,"description":18,"interventionNames":19},"Sequence 2","HGNS -\\> AtoOxy -\\> HGNS+AtoOxy -\\> Placebo\n\nEach participant receives all four treatment conditions (\"periods\") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.",[12,13,14,15],{"label":21,"type":6,"description":22,"interventionNames":23},"Sequence 3","AtoOxy -\\> HGNS -\\> Placebo -\\> HGNS+AtoOxy\n\nEach participant receives all four treatment conditions (\"periods\") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.",[12,13,14,15],{"label":25,"type":6,"description":26,"interventionNames":27},"Sequence 4","Placebo -\\> HGNS+AtoOxy -\\> AtoOxy -\\> HGNS\n\nEach participant receives all four treatment conditions (\"periods\") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.",[12,13,14,15],[29,35,42,49],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy)","Electrical stimulation of the hypoglossal nerve using an implanted device (Inspire Medical Systems) to activate upper airway dilator muscles during sleep at prescribed therapeutic settings.\n\nAtomoxetine 80 mg administered orally at bedtime. Oxybutynin 5 mg administered orally at bedtime. Dose escalation with half-dose for initial 3 nights followed by full dose.",[9,17,21,25],[34],"HGNS+AtoOxy",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition","Electrical stimulation of the hypoglossal nerve using an implanted device (Inspire Medical Systems) to activate upper airway dilator muscles during sleep at prescribed therapeutic settings.\n\nMatching placebo capsules administered orally at bedtime.",[9,17,21,25],[41],"HGNS",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Atomoxetine-plus-oxybutynin (80\u002F5 mg) (AtoOxy), active comparator condition","Atomoxetine 80 mg administered orally at bedtime. Oxybutynin 5 mg administered orally at bedtime. Dose escalation with half-dose for initial 3 nights followed by full dose.\n\nHGNS device off",[9,17,21,25],[48],"AtoOxy",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Placebo; placebo comparator condition","Matching placebo capsules administered orally at bedtime. HGNS device off",[9,17,21,25],[54],"Placebo",[56],{"name":57,"affiliation":5,"role":58},"Scott A Sands, PhD","PRINCIPAL_INVESTIGATOR",[60,66],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Daniel P Vena, PhD","CONTACT","617-852-0719",null,"dvena@bwh.harvard.edu",{"name":67,"role":62,"phone":68,"phoneExt":64,"email":69},"Dillon Gilbertson, BASc","617-732-6488","dgilbertson@bwh.harvard.edu",[71],{"facility":5,"status":64,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Boston","Massachusetts","02115","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-71.05977,42.35843,{"lat":81,"lon":80},[84,85],{"name":67,"role":62,"phone":68,"phoneExt":64,"email":69},{"name":86,"role":62,"phone":87,"phoneExt":64,"email":88},"Natalie Lawrence, BASc","7817076558","nvlawrence@bwh.harvard.edu",{"type":58,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Scott Aaron Sands","Associate Professor","100639471","phase-1-combination-upper-airway-electrical-and-pharmacological-stimulation-for-obstructive-sleep-apnea-100639471",false,"NCT07577661","Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea","Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea: A Randomized-Controlled Trial.","Inclusion Criteria for Enrolment:\n\n* Ages 18 - 79 years\n* Diagnosed OSA\n* Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization)\n* Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off \\[with\u002Fwithout pharmacotherapy\\] to assess benefits of HGNS therapy).\n\nExclusion Criteria:\n\n* Any uncontrolled medical condition\n* Current use of the medications under investigation.\n* Issues relating to short-term withdrawal of HGNS therapy\n\n  * Excluded: Occupational driving (truck drivers, fork-lift operation, taxi\u002Fuber drivers)\n  * Excluded: History of traffic accidents attributable to sleepiness or fatigue (\\\u003C2 years).\n* Use of SNRIs\u002FSSRIs or anticholinergic medications during the study.\n* Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.\n* Respiratory disorders other than sleep disordered breathing:\n\nchronic hypoventilation\u002Fhypoxemia (awake SaO2 \\\u003C 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.\n\n* Other sleep disorders: narcolepsy, parasomnias. Insomnia\n* Contraindications for atomoxetine and oxybutynin, including:\n\n  * hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria)\n  * pheochromocytoma\n  * use of monoamine oxidase inhibitors\n  * diagnosed benign prostatic hypertrophy, urinary retention\n  * suspected benign prostatic hypertrophy \u002F urinary retention based on a positive answer to either of the following questions:\n\n    1. \"During the last month, when urinating, have you had the sensation of not emptying your bladder completely more often than 1 out of 5 times?\"\n    2. \"During the last month, have you had a weak urinary stream more often than 1 out of 5 times?\n  * known untreated narrow angle glaucoma\n  * known bipolar disorder, mania, psychosis\n  * known history of major depressive disorder (age\\\u003C24).\n  * known history of attempted suicide or suicidal ideation within one year prior to screening\n  * known clinically significant constipation, gastric retention\n  * known pre-existing seizure disorders\n  * known clinically-significant kidney disorders (eGFR\\\u003C60 ml\u002Fmin\u002F1.73m2)\n  * known clinically-significant liver disorders\n  * known clinically-significant cardiovascular conditions\n  * moderate-to-severe hypertension (SBP\\>160 mmHg or DBP\\>100 mmHg measured at baseline; average of evening and morning measures)\n  * known cardiomyopathy (LVEF\\\u003C50%) or heart failure\n  * known advanced atherosclerosis\n  * recent cerebrovascular events (within 2 years)\n  * recent history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation (within 2 years)\n  * other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate\n  * myasthenia gravis\n  * pregnancy\u002Fbreast-feeding","ALL","18 Years","79 Years",{"count":103,"type":104},24,"ESTIMATED","INTERVENTIONAL",[107,108],"PHASE1","PHASE2","Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle and keep the airway open. However, some patients continue to have OSA despite using HGNS. Atomoxetine and oxybutynin, \"AtoOxy\", is a promising pharmacologcal therapy under investigation that has been shown to activate pharyngeal muscles-in particular non-genioglossus muscles--but appears more efficacious in some patients than others.\n\nThis study will test whether the combination of AtoOxy and HGNS can further improve breathing during sleep compared to either monotherapy alone. Participants with OSA and an HGNS device will be randomized to receive, in random order: HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off), in a cross-over trial.\n\nThe main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented.\n\nThe study will also examine how individual patient characteristics influence response to treatment.",[111,112],"Obstructive Sleep Apnea","Sleep-disordered Breathing",[114,115,116,117,118],"Obstructive sleep apnea","Pharmacotherapy","Hypoglossal nerve stimulation","Oxybutynin","Atomoxetine","NOT_YET_RECRUITING","2026-05-04",{"date":122,"type":123},"2026-05-11","ACTUAL",{"date":125,"type":104},"2026-06-01",{"date":127,"type":104},"2027-12-01",{"name":5,"class":6},1]