RecruitingObstructive Sleep ApneaHypertonia, MuscleNasal Airway Obstruction
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Eligible age
3–21 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: University of Michigan
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\<5 with hypoxemia.
- ✕ Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
- ✕ Active Coronavirus (COVID) 19 infections
- ✕ End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time on PSG
- ✕ Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
- ✕ Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
- ✕ Moderate/severe tracheobronchomalacia
- ✕ Need for anticoagulative therapy
Where it's recruiting
Michigan
Ann Arbor
Source: ClinicalTrials.gov · NCT05527652 · last updated 2026-03-12