Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.

Inclusion Criteria:

• Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials)
• Willingness to continue device usage.
• Confirmed diagnosis of OSA (apnea/hypopnea index; AHI > 10 or AHI >5 with lowest oxygen level ≤75%)
• At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors)
• Previous adenotonsillectomy (unless tonsillectomy not possible)
• Tonsil size 2+ or smaller

Exclusion Criteria:

• Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
• Any medical reason why ssNPA therapy may not be suitable
• Active COVID 19 infections Moderate/severe tracheobronchomalacia
• Need for anticoagulative therapy
• Bleeding disorder
• Restrictive thoracic disorders