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

Обзор

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).

Вмешательства

• Устройство 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.

Первичные конечные точки

• Apnea-hypopnea index (AHI) [Срок оценки: Up to 16 weeks]
• Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance [Срок оценки: Up to 16 weeks]

Вторичные конечные точки (4)

• Sleep quality [Срок оценки: Up to 16 weeks]
• Snoring frequency [Срок оценки: Up to 16 weeks]
• Daytime sleepiness [Срок оценки: Up to 16 weeks]
• Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument. [Срок оценки: Up to 16 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT05527652 · HUM00220966 · 1R61HL151952

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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