[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479797":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":38,"responsibleParty":59,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"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,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The University of Michigan","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-83.74088,42.27756,{"lat":51,"lon":50},[54,55,57],{"name":29,"role":32,"phone":36,"phoneExt":11,"email":37},{"name":56,"role":27,"phone":11,"phoneExt":11,"email":11},"David Zopf, MD",{"name":58,"role":27,"phone":11,"phoneExt":11,"email":11},"Louise O'Brien, PhD",{"type":27,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Louise O'Brien","Professor",[63,66],{"name":64,"class":65},"National Institutes of Health (NIH)","NIH",{"name":67,"class":65},"National Heart, Lung, and Blood Institute (NHLBI)","100479797","self-supporting-nasopharyngeal-airway-ssnpa-treating-upper-airway-obstruction-in-hypotonia-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":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"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).",[85,86,87,88,89,90],"Obstructive Sleep Apnea","Hypertonia, Muscle","Nasal Airway Obstruction","Tolerance","Trisomy 21","Down Syndrome",[92,93,86,94,95,96,97,98,99,100,101,102],"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":105,"type":106},"2026-03-12","ACTUAL",{"date":108,"type":106},"2022-11-16",{"date":110,"type":79},"2026-12",{"name":5,"class":6},1]