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NCT05527652NARecruiting

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

University of Michigan

Start Date

11/16/2022

Completion Date

12/1/2026

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 Criteria

Age Range: 3 years to 21 years

Inclusion Criteria: * 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. 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 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

Interventions

DEVICE

Self-Supporting Nasopharyngeal Airway (ssNPA)

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Conditions

Obstructive Sleep ApneaHypertonia, MuscleNasal Airway ObstructionToleranceTrisomy 21Down Syndrome

Locations

The University of Michigan

Ann Arbor, Michigan 48109

United States