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ssNPA Device for Upper Airway Obstruction

N/A

Recruiting

Led By David Zopf, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Children with Hypotonic Upper Airway Obstruction (HUAO) including those newly diagnosed with obstructive sleep apnea (OSA) with AHI>10 or AHI>5 with nocturnal hypoxemia (SpO2 nadir <=75%) confirmed by overnight polysomnography

Must not have

Restrictive thoracic disorders

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new device can help kids with a breathing condition during sleep.

Who is the study for?

This trial is for children with Hypotonic Upper Airway Obstruction and obstructive sleep apnea who've had a tonsillectomy or can't have one. They must show symptoms like snoring, daytime sleepiness, or hyperactivity. Kids with severe breathing issues during sleep, bleeding disorders, certain airway collapses, active COVID-19 infection, or those on blood thinners cannot join.

What is being tested?

The study tests if the Self-Supporting Nasopharyngeal Airway (ssNPA) device helps treat obstructive sleep apnea in kids with muscle hypotonia affecting their upper airways. It's an alternative to traditional treatments post adenotonsillectomy.

What are the potential side effects?

Potential side effects of using ssNPA may include discomfort in the nose and throat area, difficulty tolerating the device during sleep, nasal discharge or bleeding, and possible irritation at the site where the device sits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience symptoms like snoring, daytime sleepiness, or hyperactivity.

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My child has severe sleep apnea or breathing issues at night confirmed by a sleep study.

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I have had my tonsils removed or cannot have them removed due to health reasons.

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My tonsils are not very large.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition that restricts my breathing.

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I have a blockage or narrowing in my upper airway.

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I have a bleeding disorder.

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I have a moderate to severe weakness of the windpipe.

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I currently have an active COVID-19 infection.

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I need medication to prevent blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apnea-hypopnea index (AHI)

Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance

Secondary study objectives

Daytime sleepiness

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

Sleep quality

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-Supporting Nasopharyngeal Airway (ssNPA)Experimental Treatment1 Intervention

Group II: Standard of CareActive Control1 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.

0 / 10Eligibility criteria met