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.
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Ability to Tolerate Measured by Percent of Participants With Protocol Goal
Timeframe: 8 weeks
Comfort as Measured by Percent of Participants With Protocol Objective Score
Timeframe: 8 weeks
Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal
Timeframe: 8 weeks