[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568125":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":63,"collaborators":66,"id":69,"slug":20,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":20,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":20,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nasopharyngeal airway device","EXPERIMENTAL","A nasopharyngeal airway obstructive sleep apnea (\"NPA\"-OSA) device will be used for one night in a sleep laboratory and 30 days at home.",[13],"Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device","The NPA-OSA is a flexible, medical-grade silicone, tube-like device that is self-inserted into the user's nasopharyngeal airway through one nostril prior to sleep and worn throughout the night to reduce or alleviate snoring and obstructive sleep apnea.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Louise M O'Brien, PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Zahra Nourmohammadi, PhD","CONTACT","734 936-9816","znourmoh@med.umich.edu",{"name":23,"role":28,"phone":32,"phoneExt":20,"email":33},"734 647-9064","louiseo@med.umich.edu",[35,51],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Michigan Medicine","RECRUITING","Ann Arbor","Michigan","48109","United States",{"type":43,"coordinates":44},"Point",[45,46],-83.74088,42.27756,{"lat":46,"lon":45},[49,50],{"name":27,"role":28,"phone":20,"phoneExt":20,"email":30},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},{"type":43,"coordinates":53},[45,46],{"lat":46,"lon":45},[56,58,61],{"name":57,"role":28,"phone":29,"phoneExt":20,"email":30},"Zahra Nourmohammadi",{"name":59,"role":60,"phone":20,"phoneExt":20,"email":20},"Louise O'Brien, PhD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":20,"phoneExt":20,"email":20},"Jeff Plott, PhD",{"type":24,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Louise O'Brien","Professor, Sleep Medicine",[67],{"name":68,"class":6},"Wallace H Coulter Center for Translational Research","100568125",false,"NCT06677151","NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients","NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients","Inclusion Criteria:\n\n* Capacity and willingness to sign consent\n* Patient willingness to commit to and complete study over a 30-day time period\n* Confirmed diagnosis of moderate to severe OSA (AHI \\>= 15)\n* OSA caused by upper airway obstruction\n* CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy\n* Adequate manual dexterity to demonstrate ability to self-insert and remove device\n\nExclusion Criteria:\n\n* Within 3 months of initiating CPAP use, and actively using CPAP\n* Supraglottic airway collapse\n* Distal airway stenosis\n* Tracheobronchomalacia\n* Currently pregnant\n* Active COVID-19 infection\n* Need for anticoagulative therapy\n* Severe nasal allergies\n* Bleeding disorder\n* More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \\>60 mmHg for \\>10% of sleep time\n* Restrictive thoracic disorders\n* Silicone, lidocaine, neosynephrine allergy\n* Recurrent epistaxis\n* Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure","ALL","18 Years",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"NA","This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.",[85],"Sleep Apnea, Obstructive",[87],"nasopharyngeal","2026-03-10",{"date":90,"type":91},"2026-03-12","ACTUAL",{"date":93,"type":91},"2025-03-07",{"date":95,"type":79},"2026-12",{"name":5,"class":6},2]