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NCT06614582

Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

Enrolling by Invitation
NAAges 3–23InterventionalTreatment
University of Michigan
~40 participants
Updated 2025-12-02 on ClinicalTrials.gov
What's tested:Self-Supporting Nasopharyngeal Airway (ssNPA)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
Measured over Approximately 1 year
+1 more outcome measured

Conditions

Hypotonia, Muscle
Obstructive Sleep Apnea
Nasal Airway Obstruction

Explore related trials

Cerebral PalsyDown SyndromeEpisodic upper airway obstructionObstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Louise M O'Brien, PhD, MS · PRINCIPAL_INVESTIGATOR · University Michigan

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnographyApproximately 1 year

    Device efficacy will be measured by apnea/hypopnea index.

  • Long term device tolerability assessed by self-report from caregivers2 years

    This is a one question (likert scale 1-10) that participants\' caregivers will complete at the final assessment (higher scores indicating better device tolerability).