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

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction, Tolerance, Trisomy 21, Down Syndrome

In brief

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).

Key facts

Study ID

NCT05527652

Run by

University of Michigan

People needed

40

Starts

2022-11-16

Expected to finish

2026-12-01

Last updated by the study team

2026-03-12

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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
• Bleeding disorder
• Restrictive thoracic disorders

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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