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Self-Supporting Nasopharyngeal Airway (ssNPA) for Upper Airway Obstruction in Children

This study is looking at whether a device called the Self-Supporting Nasopharyngeal Airway (ssNPA) can help children with upper airway obstruction due to hypotonia (low muscle tone). This includes children newly diagnosed with obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. The ssNPA is a flexible silicone tube inserted through the nostril to keep the airway open. Researchers want to see if this device can reduce the number of breathing pauses during sleep (Apnea-hypopnea index or AHI) and if children can comfortably use it. The study plans to enroll 40 children between 3 and 21 years old who have hypotonic upper airway obstruction and obstructive sleep apnea.

Study design
This is an interventional study planning to enroll 40 participants. The specific phase of the study is not mentioned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 16 weeks to measure breathing pauses during sleep and how well they tolerate the device.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05527652

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

Recruiting
NAAges 3–21InterventionalTreatment
University of Michigan
~40 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Self-Supporting Nasopharyngeal Airway (ssNPA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apnea-hypopnea index (AHI)
Measured over Up to 16 weeks
+1 more outcome measured

Conditions

Obstructive Sleep Apnea
Hypertonia, Muscle
Nasal Airway Obstruction
Tolerance
Trisomy 21
Down Syndrome

Explore related trials

Down SyndromeHypotoniaObstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • David A Zopf, MD · PRINCIPAL_INVESTIGATOR · The University of Wisconsin
  • Louise M O'Brien, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

David A Zopf, MD
[email protected]
608-262-7181
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Apnea-hypopnea index (AHI)Up to 16 weeks

    Measured during the polysomnogram

  • Self-Supporting Nasopharyngeal Airway (ssNPA) toleranceUp to 16 weeks

    Measured by self report. Likert scale 0-5 (higher score is better)