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Recruiting NCT05527652

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

No phase Interventional Obstructive Sleep Apnea Hypertonia, Muscle Nasal Airway Obstruction Tolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Supporting Nasopharyngeal Airway (ssNPA).
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction, Tolerance. Basic parameters: 3 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Device Self-Supporting Nasopharyngeal Airway (ssNPA)
    The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis.

Primary outcome measures

  • Apnea-hypopnea index (AHI) [Time frame: Up to 16 weeks]
  • Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance [Time frame: Up to 16 weeks]
Secondary outcome measures (4)
  • Sleep quality [Time frame: Up to 16 weeks]
  • Snoring frequency [Time frame: Up to 16 weeks]
  • Daytime sleepiness [Time frame: Up to 16 weeks]
  • Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument. [Time frame: Up to 16 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Michigan — Ann Arbor

Identifiers

NCT: NCT05527652 · HUM00220966 · 1R61HL151952

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗