Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

NAEnrolling by invitationINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 23, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Hypotonia, MuscleObstructive Sleep ApneaNasal Airway Obstruction
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."

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
lead

University of Michigan

OTHER