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Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

Key facts

Where
Ann Arbor, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 3 and 23 years old?

Source: NCT06614582, who can take part

Where in United States

  • University of MichiganAnn Arbor, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
University of Michigan
Trial code
NCT06614582
Record updated
2 December 2025
Original description
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.Read full original descriptionShow less

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.

Inclusion: Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials); Willingness to continue device usage; Confirmed diagnosis of OSA (apnea/hypopnea index; AHI \> 10 or AHI \>5 with lowest oxygen level ≤75%); At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors); Previous adenotonsillectomy (unless tonsillectomy not possible); Tonsil size 2+ or smaller.

Exclusion: Any medical reason why ssNPA therapy may not be suitable; Need for anticoagulative therapy; Active COVID 19 infections Moderate/severe tracheobronchomalacia; Bleeding disorder; Restrictive thoracic disorders; Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above.

ClinicalTrials.gov NCT06614582

Under construction, not live – Long-term Evaluation of Nasopharyngeal Airway in Hypotonia (NCT06614582) – Frontlight Research