[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568125":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":64,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":20,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":20,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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",[35,52],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Michigan Medicine","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-83.74088,42.27756,{"lat":47,"lon":46},[50,51],{"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,"countryCode":42,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},{"type":44,"coordinates":54},[46,47],{"lat":47,"lon":46},[57,59,62],{"name":58,"role":28,"phone":29,"phoneExt":20,"email":30},"Zahra Nourmohammadi",{"name":60,"role":61,"phone":20,"phoneExt":20,"email":20},"Louise O'Brien, PhD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":20,"phoneExt":20,"email":20},"Jeff Plott, PhD",{"type":24,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Louise O'Brien","Professor, Sleep Medicine",[68],{"name":69,"class":6},"Wallace H Coulter Center for Translational Research","100568125","npa-osa-device-tolerability-usability-and-acclimation-clinical-study-in-adult-obstructive-sleep-apnea-osa-patients-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":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87],"Sleep Apnea, Obstructive",[89],"nasopharyngeal","2026-03-10",{"date":92,"type":93},"2026-03-12","ACTUAL",{"date":95,"type":93},"2025-03-07",{"date":97,"type":81},"2026-12",{"name":5,"class":6},2]