Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

NCT ID: NCT06614582

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

Hypotonia, Muscle; Obstructive Sleep Apnea; Nasal Airway Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-Supporting Nasopharyngeal Airway (ssNPA)

Participants will use the device up to 24 months.

Group Type: EXPERIMENTAL

Self-Supporting Nasopharyngeal Airway (ssNPA)

Intervention Type: DEVICE

The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open.

In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.

Interventions

Self-Supporting Nasopharyngeal Airway (ssNPA)

The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open.

In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Louise O'Brien

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise M O'Brien, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Powell AR, Srinivasan S, Helman JL, Li AD, O'Brien LM, Shih A, Plott JS, Zopf DA. Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation. J Clin Sleep Med. 2022 Oct 1;18(10):2497-2502. doi: 10.5664/jcsm.10202.

Reference Type: BACKGROUND

PMID: 35866230 (View on PubMed)

Other Identifiers

HUM00239400

Identifier Type: -

Identifier Source: org_study_id