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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:

• Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \[AHI\]\>10 or AHI\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \[SpO2\] nadir \<=75%).

• All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)

• Post adenotonsillectomy or those with contraindications to tonsillectomy.

• Tonsil size 2+ or smaller.

• Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.

Locations
United States
Michigan
The University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
David A Zopf, MD
dazopf@wisc.edu
608-262-7181
Backup
Louise M O'Brien, PhD
louiseo@med.umich.edu
734-647-9064
Time Frame
Start Date: 2022-11-16
Estimated Completion Date: 2026-08
Participants
Target number of participants: 40
Treatments
Experimental: Self-Supporting Nasopharyngeal Airway (ssNPA)
No_intervention: Standard of Care
Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.
Sponsors
Leads: University of Michigan
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov