Phase
Condition
Limb Spasticity
Acute Rhinitis
Bronchiectasis
Treatment
Self-Supporting Nasopharyngeal Airway (ssNPA)
Clinical Study ID
Ages 3-21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those whonewly diagnosed with obstructive sleep apnea (OSA). These children will undergoovernight polysomnography to determine the presence of OSA (apnea-hypopnea index [AHI]>10 or AHI>5 with nocturnal hypoxemia defined as oxygen saturation by pulseoximetry [SpO2] nadir <=75%).
All subjects require the presence of at least one symptom of OSA (such as snoring 3or 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 andable to provide assent, where appropriate.
Exclusion
Exclusion Criteria:
AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI<5 with hypoxemia.
Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may notbe suitable
Active Coronavirus (COVID) 19 infections
End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60mmHg for >10% of sleep time on PSG
Psychiatric, medical, or social factors likely to invalidate assessments, makeadherence 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 mostcommonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder,and Oppositional Defiant Disorder - will not be exclusions. However, more pervasiveconditions 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 ormalacia)
Moderate/severe tracheobronchomalacia
Need for anticoagulative therapy
Bleeding disorder
Restrictive thoracic disorders
Study Design
Connect with a study center
The University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
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