Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

NCT05527652 | Recruiting FDA Device

• 2 other identifiers: HUM002209661R61HL151952
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).

Conditions

Hypertonia, Muscle; Nasal Airway Obstruction; Tolerance; Obstructive Sleep Apnea; Trisomy 21; Down Syndrome

Keywords

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertonia, Muscle; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations

Outcome Measures

Primary Outcomes (2)

• Apnea-hypopnea index (AHI)

  Measured during the polysomnogram

  Up to 16 weeks

• Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance

  Measured by self report. Likert scale 0-5 (higher score is better)

  Up to 16 weeks

Secondary Outcomes (4)

• Sleep quality

  Up to 16 weeks

• Snoring frequency

  Up to 16 weeks

• Daytime sleepiness

  Up to 16 weeks

• Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.

  Up to 16 weeks

Study Arms (2)

Self-Supporting Nasopharyngeal Airway (ssNPA)

EXPERIMENTAL

Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

Standard of Care

NO INTERVENTION

Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.

Interventions

Self-Supporting Nasopharyngeal Airway (ssNPA) DEVICE

The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis.

Self-Supporting Nasopharyngeal Airway (ssNPA)

Eligibility Criteria

• Age: 3 Years - 21 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): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \[AHI\]\>10 or AHI\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \[SpO2\] nadir \<=75%).
• All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
• Post adenotonsillectomy or those with contraindications to tonsillectomy.
• Tonsil size 2+ or smaller.
• Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.

You may not qualify if:

• AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\<5 with hypoxemia.
• Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
• Active Coronavirus (COVID) 19 infections
• End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time on PSG
• Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
• Moderate/severe tracheobronchomalacia
• Need for anticoagulative therapy
• Bleeding disorder
• Restrictive thoracic disorders

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Muscle Hypertonia; Nasal Obstruction; Down Syndrome; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Intellectual Disability; Neurobehavioral Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Signs and Symptoms, Respiratory; Mental Disorders

Study Officials

• David A Zopf, MD

  The University of Wisconsin

  PRINCIPAL INVESTIGATOR

• Louise M O'Brien, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Zopf, MD

CONTACT

608-262-7181; dazopf@wisc.edu

Louise M O'Brien, PhD

CONTACT

734-647-9064; louiseo@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Aggregate and stratified outcomes will be revealed only to the unblinded statisticians with a firewall related to outcomes between statistician and investigators. Dr. Zopf will be blinded to all aggregate/stratified outcomes and Dr. O'Brien will be blinded to polysomnography and quality of life outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Eligible patients will be randomized 1:1 to receive (1) immediate therapy with the ssNPA device or (2) a waitlist control group who will receive standard of care (SoC) for the first 8 weeks and then be offered the ssNPA at week 8 for the rest of the study period (till week 16).

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: November 16, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)