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).
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 <=75%).
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/inattentive behaviors)
Post adenotonsillectomy or those with contraindications to tonsillectomy.
Tonsil size 2+ or smaller.
AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI<5 with hypoxemia.
Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
Active Coronavirus (COVID) 19 infections
End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time on PSG
University of Michigan
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator