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

Last updated: December 6, 2024
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Limb Spasticity

Acute Rhinitis

Bronchiectasis

Treatment

Self-Supporting Nasopharyngeal Airway (ssNPA)

Clinical Study ID

NCT05527652
HUM00220966
1R61HL151952
  • Ages 3-21
  • All Genders

Study 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

Inclusion Criteria:

  • Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those whonewly diagnosed with obstructive sleep apnea (OSA). These children will undergoovernight polysomnography to determine the presence of OSA (apnea-hypopnea index [AHI]>10 or AHI>5 with nocturnal hypoxemia defined as oxygen saturation by pulseoximetry [SpO2] nadir <=75%).

  • All subjects require the presence of at least one symptom of OSA (such as snoring 3or 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 andable to provide assent, where appropriate.

Exclusion

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 notbe suitable

  • Active Coronavirus (COVID) 19 infections

  • End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60mmHg for >10% of sleep time on PSG

  • Psychiatric, medical, or social factors likely to invalidate assessments, makeadherence 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 mostcommonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder,and Oppositional Defiant Disorder - will not be exclusions. However, more pervasiveconditions 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 ormalacia)

  • Moderate/severe tracheobronchomalacia

  • Need for anticoagulative therapy

  • Bleeding disorder

  • Restrictive thoracic disorders

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Self-Supporting Nasopharyngeal Airway (ssNPA)
Phase:
Study Start date:
November 16, 2022
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • The University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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