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

University of Michigan

Status: Enrolling

Conditions: Hypertonia, Muscle; Trisomy 21; Down Syndrome; Tolerance; Obstructive Sleep Apnea; Nasal Airway Obstruction

Treatments: Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05527652

HUM00220966

1R61HL151952

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Self-Supporting Nasopharyngeal Airway (ssNPA)

Experimental group

Treatment:

Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

Standard of Care

No Intervention group

Description:

Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.