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ENROLLING BY INVITATION
NCT06614582
NA

Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Years - 23 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-10-23

Completion Date

2026-10

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States