Actively Recruiting
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Led by University of Michigan · Updated on 2026-03-12
40
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with Hypotonic Upper Airway Obstruction newly diagnosed with obstructive sleep apnea (AHI >10 or AHI >5 with oxygen saturation nadir ≤75%)
- Presence of at least one symptom of obstructive sleep apnea such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors
- Post adenotonsillectomy or 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
You will not qualify if you...
- Apnea-hypopnea index ≤10 on polysomnography without hypoxemia or AHI <5 with hypoxemia
- Any medical reason making ssNPA therapy unsuitable
- Active Coronavirus (COVID) 19 infection
- End-tidal or transcutaneous carbon dioxide values >60 mmHg for >10% of sleep time
- Psychiatric, medical, or social factors likely to invalidate assessments, cause poor adherence, or prevent follow-up; severe autism excluded
- Presence of supraglottic airway collapse or distal airway stenosis or collapse
- Moderate or severe tracheobronchomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
D
David A Zopf, MD
CONTACT
L
Louise M O'Brien, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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