Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia (ssNPA)

Pilot Study of Novel Nasopharyngeal Airway Device for Treating Upper Airway Obstruction in Pediatric Hypotonia

Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence. The multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.

There is a critical need for safe and effective treatment options for persistent obstructive sleep apnea (OSA) in patients with Hypotonic Upper Airway Obstruction (HUAO). HUAO encompass conditions such as cerebral palsy, hypoxic encephalopathy, syndromic tone anomalies, and neuromuscular disorders, and typically share a similar pattern of multisite upper airway collapse. OSA is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep with associated arousals and/ or oxygen desaturations. Of hypotonic patients with symptoms of sleep disordered breathing, one quarter have moderate OSA, and more than half have severe OSA. Thus, not only are patients more likely to have OSA, but it is likely to be much more severe. Currently available treatment options, ranging from palliative care to tracheostomy, often fail to fully meet the needs of these patients. The multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal airway stent that has demonstrated good tolerability in hypotonic patients. This initial phase will test an enhanced version of the device for acceptability and tolerability. Critically, insertion, adherence, and compliance protocols will be optimized for preparation of the full trial.

The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA

Optimize insertion protocol with ease of insertion >= 5 on Likert scale of 1-10 in 60% of participants (higher score is better)

Inclusion Criteria: hypotonia obstructive sleep apnea on polysomnogram with AHI>=10 presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors) Exclusion Criteria: AHI <10 any reason why ssNPA may not be suitable Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible Safe Continuous positive airway pressure therapy (CPAP) use is possible and tolerated Supraglottic airway collapse Distal airway stenosis Tracheobronchomalacia Active COVID 19 infection Need for anticoagulative therapy Bleeding disorder More than mild elevation of end tidal carbon dioxide (ETCO2) or transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time Restrictive thoracic disorders Silicone, lidocaine, neosynephrine allergy