[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619341":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":47,"collaborators":49,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":97,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":26},{"fullName":5,"class":6},"Zeus Sleep Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","ACTIVE_COMPARATOR","Continuous Positive Airway Pressure (CPAP)",[13],"Device: CPAP",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention","EXPERIMENTAL","Transcutaneous Electrical Stimulation (ZeusOSA)",[19],"Device: ZeusOSA",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ZeusOSA","Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"CPAP","Continous positive airway pressure (CPAP) when asleep",[9],[32],{"name":33,"affiliation":34,"role":35},"Joerg Steier, PhD","Guy's & St Thomas' NHS Foundation Trust, London, UK","STUDY_CHAIR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Nigel Clarke, CEO","CONTACT","+442071883434","x83435","support@zeussleeps.com",{"name":44,"role":39,"phone":45,"phoneExt":46,"email":26},"Salma Ayyis, PhD","+442071882823","x82821",{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[50,53,55,57,60,62,64,67,69],{"name":51,"class":52},"Guy's and St Thomas' NHS Foundation Trust","OTHER",{"name":54,"class":52},"King's College London",{"name":56,"class":52},"Royal Brompton & Harefield NHS Foundation Trust",{"name":58,"class":59},"Queen Victoria Hospital NHS Foundation Trust","OTHER_GOV",{"name":61,"class":52},"The Queen Elizabeth Hospital",{"name":63,"class":52},"Imperial College Healthcare NHS Trust",{"name":65,"class":66},"AintreeNHSTrust","UNKNOWN",{"name":68,"class":52},"University of Southampton",{"name":70,"class":59},"Royal Papworth Hospital","100619341","transcutaneous-electrical-stimulation-in-patients-with-obstructive-sleep-apnoea-100619341",false,"NCT07343362","Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea","Zeus Sleep Technology: A UK-based Multi-centre Randomised Controlled Trial Using Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea (TESLA)","TESLA-MICRON","Inclusion Criteria:\n\n1. Adult participants (≥18 years) who have OSA with an AHI between 5-40 events\u002Fhour, as measured by the baseline sleep study (3 nights off CPAP).\n2. If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours\u002Fnight on fewer than 70% of nights over a minimum period of 3 months prior to enrolment.\n3. Adults with a body mass index (BMI) of 18.5-32.0 kg\u002Fm2 (inclusive)\n4. Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).\n5. Able and willing to provide informed written consent.\n6. Access to a smartphone and internet at home.\n\nExclusion Criteria:\n\n1. Hypercapnic patients (pCO2\\>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \\>28mmol\u002FL).\n2. Adults with significantly enlarged tonsils (size 3-4)\n3. Adults with polyps or adenoids, hypoglossal nerve palsy,\n4. Adults with notable medical co-morbidities that could potentially impact participation in or the achievement of the study's objectives (e.g., significant heart failure (New York Heart Association, NYHA class III-IV), recent myocardial infarction (within 3 months) and significant cardiac arrhythmias, uncontrolled hypertension).\n5. Participants with an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data.\n6. Participants with active implantable medical devices, including but not limited to cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cochlear implants, deep brain stimulation (DBS) systems, vagus nerve stimulation (VNS) devices, neurostimulators, or implanted infusion pumps.\n7. Participants with metallic implants in the head or neck region that, in the opinion of the Investigator, may interfere with the safe use of the investigational device.\n8. Participants who are physically incapacitated such as to manoeuvre the ZeusOSA device\n9. Adults with long facial hair that interferes with the correct placement of the hydrogel pad, and who are unwilling to shave.\n10. Participants with an allergy to plasters or similar products.","ALL","18 Years",{"count":82,"type":83},186,"ESTIMATED","INTERVENTIONAL",[86],"NA","The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous positive airway pressure (CPAP) therapy over a period of 3-months in the community and compare results against usual care (ongoing CPAP therapy), evaluate acceptability, comfort and adverse events, and record outcomes for provision of the health economics analysis. The proposed study will provide us with data about the efficacy of the domiciliary use of the intervention from a UK-based prospective, multi-centre and randomised controlled trial (Phase III). We will understand whether the primary outcome parameter, the apnoea hypopnea index (AHI), or the secondary outcomes (e.g. 4% oxygen desaturation index (ODI), the Epworth Sleepiness Scale (ESS), compliance and comfort, Functional Outcome of Sleep Questionnaires (FOSQ), European Quality of Life Questionnaire (EQ-5D)) are suitable measures to assess control of OSA using TESLA within reasonable acceptance for the patients to provide the analysis of healthcare resource usage for assessment of cost-efficacy and quality-adjusted life years (QALYs). Responder analysis will provide insights into gender, socio-economic background and endotypes to predict who most suitably benefits from this treatment.",[89],"Obstructive Sleep Apnea",[28,91,92,93,94,77,95,96,5],"Continuous Positive Airway Pressure","Hypoglossal Nerve Stimulation","non-CPAP therapy","sleep-disordered breathing","Zeus Sleep Technology","transcutaneous electrical stimulation","NOT_YET_RECRUITING","2026-07-17",{"date":100,"type":101},"2026-07-21","ACTUAL",{"date":103,"type":83},"2026-07-16",{"date":105,"type":83},"2028-09",{"name":5,"class":6}]