NCT05527652 Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
| NCT ID | NCT05527652 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-11-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-11-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
David A Zopf, MD
PRINCIPAL INVESTIGATOR
The University of Wisconsin
Frequently Asked Questions
Who can join the NCT05527652 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 21 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05527652 currently recruiting?
Yes, NCT05527652 is actively recruiting participants. Contact the research team at dazopf@wisc.edu for enrollment information.
Where is the NCT05527652 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05527652 clinical trial?
NCT05527652 is sponsored by University of Michigan. The principal investigator is David A Zopf, MD at The University of Wisconsin. The trial plans to enroll 40 participants.