Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
A legfontosabb adatok
- Hol
- Ann Arbor (Egyesült Államok)A helyszín megnézése
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Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 3 és 21 év között vagy?
Forrás: NCT05527652: ki vehet részt
Helyszínek itt: Egyesült Államok
- The University of MichiganAnn Arbor, Egyesült ÁllamokContact: Louise M O'Brien, PhDRésztvevőt keres
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- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Michigan
- Azonosító
- NCT05527652
- A regiszteradat frissítve
- 2026. augusztus 19.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
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).
Bevonási feltételek: 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.
Kizáró feltételek: Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable; Need for anticoagulative therapy; Active Coronavirus (COVID) 19 infections; 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; Bleeding disorder; Restrictive thoracic disorders; AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI<5 with hypoxemia; End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time on PSG; 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.