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)
Conditions
Obstructive Sleep ApneaHypertonia, MuscleNasal Airway ObstructionToleranceTrisomy 21Down Syndrome
Locations
The University of Michigan
Ann Arbor, Michigan 48109
United States