RecruitingNot ApplicableNCT05527652
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Sponsor
University of Michigan
Enrollment
40 participants
Start Date
Nov 16, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 3 YearsMax Age: 21 Years
Inclusion Criteria5
- 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 Criteria10
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICESelf-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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05527652
Related Trials
Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
NCT071952531 location
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
NCT074162011 location
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
NCT0722568637 locations
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
NCT0722676528 locations
Gamma Frequency Stimulation in Individuals With Down Syndrome
NCT051969841 location