[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623439":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":28,"responsibleParty":49,"collaborators":27,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":27,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":27,"enrollmentInfo":60,"targetDuration":27,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":31,"whyStopped":27,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Notos Medical Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-invasive electrical stimulation of the upper airway","EXPERIMENTAL","Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy.",[13],"Device: Non-invasive electrical stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Non-invasive electrical stimulation","The non-invasive electrical stimulation components will consist of two Digitimer DS5 isolated current stimulators, voltage control by an NI-9262 module, and two pairs of adhesive electrodes placed in the submandibular region.",[9],[21],"Breathe Study System",[23],{"name":24,"affiliation":25,"role":26},"Johan Verbraecken","Universiteit Antwerpen","PRINCIPAL_INVESTIGATOR",null,[29],{"facility":30,"status":31,"city":32,"state":27,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Antwerp University Hospital","RECRUITING","Edegem","2650","Belgium","BE",{"type":37,"coordinates":38},"Point",[39,40],4.44504,51.15662,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Verena Iven","CONTACT","+ 32 3 821 37 58","studies.slaapcentrum@uza.be",{"name":24,"role":26,"phone":27,"phoneExt":27,"email":27},{"type":50,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100623439","feasibility-of-upper-airway-stimulation-in-osa-100623439",false,"NCT07396649","Feasibility of Upper Airway Stimulation in OSA","Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea","Inclusion Criteria:\n\n* Obstructive sleep apnoea diagnosis with an AHI of 15-50 events\u002Fhour recorded in the baseline polysomnography (PSG)\n* BMI \\\u003C 32 kg\u002Fm²\n* Age \\> 18 years old\n* Able to read, write, and speak Dutch with acceptable visual and auditory acuity\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt\n* Central (non-obstructive) AHI episodes \\>5 events\u002Fhour recorded in the baseline PSG\n* Inability to sleep supine\n* Pregnancy\n* Inability to undergo DISE\n* Inability or unwillingness to shave under and around their chin and neck if appropriate\n* Known inability to complete PSG with a total sleep time of \\> 4 hours\n* The use of other neurostimulatory devices\n* A diagnosis of periodic leg movement disorder\n* Awake resting arterial oxygen saturation \\\u003C93% (suggesting possible hypoventilation)\n* Unstable, untreated coronary or peripheral artery disease\n* Severe arterial hypertension defined as a resting blood pressure (BP) of \\>180\u002F110mmHg\n* Currently employed as a professional driver\n* Any previous sleep-related driving accident\n* A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)","ALL","19 Years",{"count":61,"type":62},15,"ESTIMATED","INTERVENTIONAL",[65],"NA","Project Breathe 1 is a short-duration (5 month) pilot investigation to assess the safety and tolerability of non-invasive electrical stimulation in adults with obstructive sleep apnoea. The investigation is an unblinded, uncontrolled, single arm design.",[68],"Obstructive Sleep Apnoea (OSA)",[70,71,72],"obstructive sleep apnoea","OSA","sleep apnoea","2026-02-05",{"date":75,"type":76},"2026-02-09","ACTUAL",{"date":78,"type":76},"2026-01-29",{"date":80,"type":62},"2026-07",{"name":5,"class":6},1]