[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479797":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":38,"responsibleParty":58,"collaborators":61,"id":67,"slug":11,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Self-Supporting Nasopharyngeal Airway (ssNPA)","EXPERIMENTAL",null,[13],"Device: Self-Supporting Nasopharyngeal Airway (ssNPA)",{"label":15,"type":16,"description":17,"interventionNames":11},"Standard of Care","NO_INTERVENTION","Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.",[19],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"DEVICE","The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis.",[9],[24,28],{"name":25,"affiliation":26,"role":27},"David A Zopf, MD","The University of Wisconsin","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":27},"Louise M O'Brien, PhD",[31,35],{"name":25,"role":32,"phone":33,"phoneExt":11,"email":34},"CONTACT","608-262-7181","dazopf@wisc.edu",{"name":29,"role":32,"phone":36,"phoneExt":11,"email":37},"734-647-9064","louiseo@med.umich.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The University of Michigan","RECRUITING","Ann Arbor","Michigan","48109","United States",{"type":47,"coordinates":48},"Point",[49,50],-83.74088,42.27756,{"lat":50,"lon":49},[53,54,56],{"name":29,"role":32,"phone":36,"phoneExt":11,"email":37},{"name":55,"role":27,"phone":11,"phoneExt":11,"email":11},"David Zopf, MD",{"name":57,"role":27,"phone":11,"phoneExt":11,"email":11},"Louise O'Brien, PhD",{"type":27,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Louise O'Brien","Professor",[62,65],{"name":63,"class":64},"National Institutes of Health (NIH)","NIH",{"name":66,"class":64},"National Heart, Lung, and Blood Institute (NHLBI)","100479797",false,"NCT05527652","Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia","Inclusion Criteria:\n\n* Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \\[AHI\\]\\>10 or AHI\\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \\[SpO2\\] nadir \\\u003C=75%).\n* All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive\u002Finattentive behaviors)\n* Post adenotonsillectomy or those with contraindications to tonsillectomy.\n* Tonsil size 2+ or smaller.\n* Parent\u002Fcaregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.\n\nExclusion Criteria:\n\n* AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\\\u003C5 with hypoxemia.\n* Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable\n* Active Coronavirus (COVID) 19 infections\n* End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \\>60 mmHg for \\>10% of sleep time on PSG\n* Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit\u002FHyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.\n* Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)\n* Moderate\u002Fsevere tracheobronchomalacia\n* Need for anticoagulative therapy\n* Bleeding disorder\n* Restrictive thoracic disorders","ALL","3 Years","21 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"NA","The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).",[83,84,85,86,87,88],"Obstructive Sleep Apnea","Hypertonia, Muscle","Nasal Airway Obstruction","Tolerance","Trisomy 21","Down Syndrome",[90,91,84,92,93,94,95,96,97,98,99,100],"Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Apnea","Respiration Disorders","Respiratory Tract Diseases","Sleep Disorders, Intrinsic","Dyssomnias","Sleep Wake Disorders","Nervous System Diseases","Neuromuscular Manifestations","Neurologic Manifestations","2026-03-10",{"date":103,"type":104},"2026-03-12","ACTUAL",{"date":106,"type":104},"2022-11-16",{"date":108,"type":77},"2026-12",{"name":5,"class":6},1]