The University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Location contact
David Zopf, MD
PRINCIPAL_INVESTIGATOR
Louise M O'Brien, PhD
CONTACT
Louise O'Brien, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05527652
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).
Interested in participating?
Request Info3 year–21 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
David Zopf, MD
PRINCIPAL_INVESTIGATOR
Louise M O'Brien, PhD
CONTACT
Louise O'Brien, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 16 weeks
Measured during the polysomnogram
Time frame: Up to 16 weeks
Measured by self report. Likert scale 0-5 (higher score is better)
Time frame: Up to 16 weeks
Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
David A Zopf, MD
CONTACT
Louise M O'Brien, PhD
CONTACT
University of Michigan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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