[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633716":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":23,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":33,"whyStopped":23,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"PSG-SUN","Participants will first undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. After this in-lab recording period, they will complete an at-home sleep assessment using the Sunrise device over the predefined home recording period.",[12],"Device: Sunrise",{"label":14,"type":6,"description":15,"interventionNames":16},"SUN-PSG","Participants will first complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. After this home recording period, they will undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Sunrise","The Sunrise device is a single-use, mandibular movement-based sleep monitoring sensor designed to assess sleep architecture and respiratory events at home. In this study, Sunrise is evaluated as an alternative to in-laboratory polysomnography (PSG), which is considered the current gold-standard reference for sleep assessment.",[9,14],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Marie JOYEUX-FAURE, Pr","CONTACT","+33(0)476767166","MJoyeuxfaure@chu-grenoble.fr",[31],{"facility":32,"status":33,"city":34,"state":23,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"CHU Grenoble Alpes","RECRUITING","Grenoble","38043","France","FR",{"type":39,"coordinates":40},"Point",[41,42],5.71479,45.17869,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":23,"email":29},"Marie Joyeux-Faure, MD","33(0)476767166",{"type":49,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[51],{"name":52,"class":53},"Polyclinique Saint Laurent - Rennes","UNKNOWN","100633716","treatment-failure-of-continuous-positive-airway-pressure-cpap-in-patients-with-obstructive-sleep-apnea-syndrome-osa-a-trial-comparing-polysomnography-and-the-sunrise-device-to-drive-treatment-adjustment-decisions-100633716",false,"NCT07530302","Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.","Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Randomized Controlled Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.","SUNCPAP","Inclusion Criteria:\n\n* Adults aged 18 to 85 years\n* Patients treated with Resmed CPAP\n* Residual apnea-hypopnea index under CPAP (rAHI(CPAP) \\> 10 events\u002Fhour)\n* Access to a smartphone and home internet connection, and ability to use a mobile application\n* Signed informed consent\n* Affiliated with, or beneficiary of, a national health insurance program\n\nExclusion Criteria:\n\n* Severe chronic obstructive or restrictive pulmonary disease, with or without supplemental oxygen\n* Unstable cardiovascular disease or severe heart failure requiring hospitalization within the past 3 months, or meeting New York Heart Association (NYHA) class III or IV criteria\n* Conditions affecting mandibular condyle rotation or temporomandibular joint function\n* Refusal to shave excessive facial hair when required for proper placement of the Sunrise device\n* Participation in another interventional clinical study or currently within an exclusion period of another study\n* Individuals who, in the investigator's judgment, are unlikely to comply with study procedures or requirements\n* Individuals who cannot be contacted in case of emergency\n* Persons protected under French Public Health Code articles L1121-5, L1121-6, and L1121-8 (including pregnant or breastfeeding women, persons deprived of liberty, individuals under psychiatric care under articles L.3212-1 or L.3213-1, individuals admitted to healthcare or social institutions for reasons other than research, and persons under legal protection or unable to provide informed consent)\n* Staff members with a hierarchical relationship to the principal investigator","ALL","18 Years","85 Years",{"count":66,"type":67},105,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to determine whether treatment-adjustment decisions based on one night of home monitoring with the Sunrise device are comparable to decisions based on one night of in-laboratory polysomnography (PSG) in adults with obstructive sleep apnea (OSA) who remain insufficiently controlled with continuous positive airway pressure (CPAP) therapy.\n\nThe main questions it aims to answer are:\n\n* Do Sunrise-based assessments lead to similar therapeutic decisions as PSG-based assessments?\n* Are residual apnea-hypopnea indices measured by Sunrise comparable to those measured by PSG?\n\nParticipants will complete both assessment sequences in a randomized cross-over design. They will:\n\n* Use the Sunrise device for several nights with and without CPAP.\n* Undergo one night of PSG with and without CPAP.\n* Have their CPAP therapy reviewed based on the results of each assessment method.",[73],"Sleep Apnea Syndrome, Obstructive",[75,76,77,78],"Obstructive sleep apnea","Randomized","Cross-over","CPAP","2026-06-15",{"date":81,"type":82},"2026-06-17","ACTUAL",{"date":84,"type":82},"2026-06-10",{"date":86,"type":67},"2029-09",{"name":5,"class":6},1]