NCT05527652

Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Obstructive Sleep Apnea
• Hypertonia, Muscle
• Nasal Airway Obstruction
• Tolerance
• Trisomy 21
• Down Syndrome

Interventions

Type	Name	Description
DEVICE	Self-Supporting Nasopharyngeal Airway (ssNPA)	The 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.

Timeline

• Start date: 2022-11-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-09-02
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study