Using a special airway device to treat sleep apnea in children with weak muscles
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
This study is testing a special airway device to see if it can help children with weak muscles who have sleep apnea breathe better at night without needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 21 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05527652 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children with Hypotonic Upper Airway Obstruction who have been newly diagnosed with obstructive sleep apnea and exhibit specific symptoms.
Not a fit: Patients with mild obstructive sleep apnea or those who have medical reasons that contraindicate the use of the ssNPA device may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall health in children suffering from obstructive sleep apnea.
How similar studies have performed: While the use of airway devices in treating sleep apnea is established, the specific application of the ssNPA in this population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.