Using a special airway device to treat sleep apnea in children with weak muscles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of the Self-Supporting Nasopharyngeal Airway (ssNPA) device in treating obstructive sleep apnea in children diagnosed with Hypotonic Upper Airway Obstruction (HUAO). Participants will undergo overnight polysomnography to assess the severity of their condition and determine eligibility based on specific apnea-hypopnea index (AHI) criteria. The study aims to provide a non-invasive solution for children who may not be suitable candidates for surgical interventions. The trial is sponsored by the University of Michigan in collaboration with the NIH and NHLBI.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: David A Zopf, MD — The University of Wisconsin
• Study coordinator: David A Zopf, MD
• Email: dazopf@wisc.edu
• Phone: 608-262-7181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.