University of Michigan
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 ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open. In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.
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