Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- * 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
Ages Eligible for Study
3 Years to 21 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No