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
Parallel
Self-Supporting Nasopharyngeal Airway (ssNPA)
DeviceThe 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.
Apnea-hypopnea index (AHI)
Measured during the polysomnogram
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Measured by self report. Likert scale 0-5 (higher score is better)
Sleep quality
Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Snoring frequency
As reported by participant/care taker in survey given daily. Snoring frequency is rated on a Likert scale 1-5 where 5 indicates snoring more frequently.
Daytime sleepiness
Measured using the children's Epworth Sleepiness Scale - The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total quality of life score is the sum of all the items over the number of items answered on all scales.
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University of Michigan
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
