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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
The University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGApnea-hypopnea index (AHI)
Measured during the polysomnogram
Time frame: Up to 16 weeks
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Measured by self report. Likert scale 0-5 (higher score is better)
Time frame: Up to 16 weeks
Sleep quality
Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Time frame: Up to 16 weeks
Snoring frequency
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.
Time frame: Up to 16 weeks
Daytime sleepiness
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).
Time frame: Up to 16 weeks
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
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.
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Time frame: Up to 16 weeks