Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
NCT ID: NCT05527652
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-11-16
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Self-Supporting Nasopharyngeal Airway (ssNPA)
Self-Supporting Nasopharyngeal Airway (ssNPA)
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.
Standard of Care
Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.
No interventions assigned to this group
Interventions
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Self-Supporting Nasopharyngeal Airway (ssNPA)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
21 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
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David Zopf
Adjunct Associate Professor of Otolaryngology-Head and Neck Surgery
Principal Investigators
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David A Zopf, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Wisconsin
Louise M O'Brien, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Louise M O'Brien, PhD
Role: primary
Other Identifiers
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HUM00220966
Identifier Type: -
Identifier Source: org_study_id