Down Syndrome, Hypertonia, Muscle, Nasal Airway Obstruction, Obstructive Sleep Apnea, Tolerance, Trisomy 21
Conditions
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
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).
Interventions
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.
Sponsors
University of Michigan
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Aggregate and stratified outcomes will be revealed only to the unblinded statisticians with a firewall related to outcomes between statistician and investigators. Dr. Zopf will be blinded to all aggregate/stratified outcomes and Dr. O'Brien will be blinded to polysomnography and quality of life outcomes.
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).
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index (AHI) | Up to 16 weeks | Measured during the polysomnogram |
| Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance | Up to 16 weeks | Measured by self report. Likert scale 0-5 (higher score is better) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | Up to 16 weeks | Higher score in parent report of sleep quality on scale 0-5 (higher score is better) |
| Snoring frequency | Up to 16 weeks | As reported by participant/care taker in survey given daily. Snoring frequency is rated on a Likert scale 1-5 where 5 indicates snoring more frequently. |
| Daytime sleepiness | Up to 16 weeks | Measured using the children's Epworth Sleepiness Scale - The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score). |
| Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument. | Up to 16 weeks | There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total quality of life score is the sum of all the items over the number of items answered on all scales. |
Countries
United States
Contacts
CONTACTDavid A Zopf, MD
CONTACTLouise M O'Brien, PhD
PRINCIPAL_INVESTIGATORDavid A Zopf, MD
The University of Wisconsin
PRINCIPAL_INVESTIGATORLouise M O'Brien, PhD
University of Michigan
Outcome results
None listed