NCT06614582

Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 3 Years – 23 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypotonia, Muscle
• Obstructive Sleep Apnea
• Nasal Airway Obstruction

Interventions

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

Timeline

• Start date: 2024-10-23
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-09-26
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study