Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

University of Michigan

Status: Invitation-only

Conditions: Hypotonia, Muscle; Obstructive Sleep Apnea; Nasal Airway Obstruction

Treatments: Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06614582

HUM00239400

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 23 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Self-Supporting Nasopharyngeal Airway (ssNPA)

Experimental group

Description:

Participants will use the device up to 24 months.

Treatment:

Device: Self-Supporting Nasopharyngeal Airway (ssNPA)