An interventional study of Self-Supporting Nasopharyngeal Airway (ssNPA) in Hypotonia, Muscle, Obstructive Sleep Apnea and Nasal Airway Obstruction, sponsored by University of Michigan. Enrolling by invitation at 1 site in United States. Open to participants aged 3 Years to 23 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
64 studies on the registry are indexed under Muscle Hypotonia; 15 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 45 interventional studies indexed under Muscle Hypotonia.
Browse Muscle Hypotonia studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will use the device up to 24 months.
Device: Self-Supporting Nasopharyngeal Airway (ssNPA)
The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open. In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
Device efficacy will be measured by apnea/hypopnea index.
Time frame: Approximately 1 year
Long term device tolerability assessed by self-report from caregivers
This is a one question (likert scale 1-10) that participants\' caregivers will complete at the final assessment (higher scores indicating better device tolerability).
Time frame: 2 years
Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality
This will be a on a scale 1-10 (higher score is better).
Time frame: 1-2 years
Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)
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 receive 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Time frame: 1-2 years
Long-term impact on quality of life will be assessed with the OSA-18
This is an obstructive sleep apnea-specific quality of life tool for children and the Pediatric Quality of Life Inventory (PedsQL), a standard health-related quality of life instrument. Scores range from 0-126 with higher scores indicting worse impact. 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.
Time frame: 1-2 years
Family Impact Questionnaire (FIQ)
This tool measures parent's perceptions of the child's negative impact on the family. The FIQ is a 50-item, four-point Likert scale ranging from 0 (not at all) to 3 (very much) that asks about the impact the child has had on the family (e.g., social life, finances, marriage, and siblings) compared to the impact other children his/her age have on their families. Higher score is more significant impact.
Time frame: 1-2 years
Plan to share: No — Small number of complex children that could be identified by sharing Individual participant data (IPD).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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