Recruiting

ssNPA

Sponsor:

University of Michigan

Code:

NCT05527652

Conditions

Obstructive Sleep Apnea

Hypertonia, Muscle

Nasal Airway Obstruction

Tolerance

Trisomy 21

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

Interventions

Self-Supporting Nasopharyngeal Airway (ssNPA)

Study Details

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

Obstructive Sleep Apnea

Hypertonia, Muscle

Nasal Airway Obstruction

Tolerance

Trisomy 21

Study ID

NCT05527652

Start date

Nov 16, 2022

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-Supporting Nasopharyngeal Airway (ssNPA)

no intervention: Standard of Care

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)

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.

Primary outcome measure

  • Apnea-hypopnea index (AHI) [ Time Frame: Up to 16 weeks ]
  • Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance [ Time Frame: Up to 16 weeks ]

Central Contacts and Locations

Central contacts

David A Zopf, MD

608-262-7181dazopf@wisc.edu

Louise M O'Brien, PhD

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

Locations

The University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Louise M O'Brien, PhD

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

Principal Investigator:

David Zopf, MD

More Information

Sponsor

University of Michigan

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-08-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.