Trial Summary
What is the purpose of this trial?
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.
Research Team
LM
Louise M O'Brien, PhD, MS
Principal Investigator
University Michigan
Eligibility Criteria
This trial is for children with muscle hypotonia causing upper airway obstruction, leading to issues like obstructive sleep apnea. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.Inclusion Criteria
I have been diagnosed with sleep apnea.
I often snore, feel sleepy during the day, or have trouble paying attention.
My tonsils are not enlarged beyond a moderate size.
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Exclusion Criteria
Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
I need medication to prevent blood clots.
I have a bleeding disorder.
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Treatment Details
Interventions
- Self-Supporting Nasopharyngeal Airway (ssNPA) (Device)
Trial OverviewThe study focuses on the long-term effectiveness of a device called ssNPA in treating obstructive sleep apnea caused by hypotonia. It aims to understand how well this nasal airway device works over an extended period.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Self-Supporting Nasopharyngeal Airway (ssNPA)Experimental Treatment1 Intervention
Participants will use the device up to 24 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Trials
1,891
Recruited
6,458,000+
Marschall S. Runge
University of Michigan
Chief Executive Officer since 2015
MD, PhD
Karen McConnell
University of Michigan
Chief Medical Officer since 2020
MD
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