Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

NCT06614582 | Enrolling By Invitation FDA Device

• 1 other identifier: HUM00239400
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Self-Supporting Nasopharyngeal Airway (ssNPA); Sleep study; Difficulty breathing; Obstructive Sleep Apnea; Cerebral Palsy; Down syndrome; Trisomy 21

Outcome Measures

Primary Outcomes (2)

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

  Device efficacy will be measured by apnea/hypopnea index.

  Approximately 1 year

• Long term device tolerability assessed by self-report from caregivers

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

  2 years

Secondary Outcomes (4)

• Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality

  1-2 years

• Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)

  1-2 years

• Long-term impact on quality of life will be assessed with the OSA-18

  1-2 years

• Family Impact Questionnaire (FIQ)

  1-2 years

Study Arms (1)

Self-Supporting Nasopharyngeal Airway (ssNPA)

EXPERIMENTAL

Participants will use the device up to 24 months.

Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

Interventions

Self-Supporting Nasopharyngeal Airway (ssNPA) 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.

Self-Supporting Nasopharyngeal Airway (ssNPA)

Eligibility Criteria

• Age: 3 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 35866230 BACKGROUND

MeSH Terms

Conditions

Muscle Hypotonia; Sleep Apnea, Obstructive; Nasal Obstruction; Dyspnea; Cerebral Palsy; Down Syndrome

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Louise M O'Brien, PhD, MS

  University Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single group intervention for participants who have completed NCT05527652 (Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia)

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)