Clinical trial NCT05527652: Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Official title: Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Hypertonia, Muscle
Nasal Airway Obstruction
Tolerance
Trisomy 21
Down Syndrome
Keywords: Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertonia, Muscle
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-09-02
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized 1:1 to receive (1) immediate therapy with the ssNPA device or (2) a waitlist control group who will receive standard of care (SoC) for the first 8 weeks and then be offered the ssNPA at week 8 for the rest of the study period (till week 16).
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: Up to 16 weeks
measure: Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Sleep quality
timeFrame: Up to 16 weeks
measure: Snoring frequency
timeFrame: Up to 16 weeks
measure: Daytime sleepiness
timeFrame: Up to 16 weeks
measure: Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: The University of Wisconsin
name: David A Zopf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Louise M O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References: