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

Launched by UNIVERSITY OF MICHIGAN · Aug 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Self-Supporting Nasopharyngeal Airway (ssNPA) to see if it can help treat obstructive sleep apnea (OSA) in children with a condition known as Hypotonic Upper Airway Obstruction (HUAO). Researchers want to find out if this device can improve breathing during sleep for kids who have trouble because their throat muscles are weak and can't keep their airways open. The trial is currently looking for children aged 3 to 21 years who show symptoms of OSA, such as snoring frequently, feeling very sleepy during the day, or having difficulty focusing.

To be eligible for the trial, children must have been diagnosed with OSA and show at least one related symptom. They should have undergone a sleep study to confirm the diagnosis. Parents or caregivers will need to give their consent, and children may need to agree to participate as well. Participants can expect to be monitored over a period of 8 weeks to see how well the ssNPA device works for them. It's important to note that some children may not be suitable for this trial due to other medical conditions, so a careful selection process is in place. This study aims to find new ways to help children breathe better while they sleep, which can lead to improved health and well-being.

Gender

ALL

Eligibility criteria

• 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