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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea-hypopnea index (AHI)
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Secondary outcome measures
Daytime sleepiness
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
Sleep quality
+1 more

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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,482 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,684 Previous Clinical Trials
6,930,858 Total Patients Enrolled
1 Trials studying Nasal Obstruction
242 Patients Enrolled for Nasal Obstruction
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,717 Total Patients Enrolled

Media Library

Self-Supporting Nasopharyngeal Airway (ssNPA) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05527652 — N/A
Nasal Obstruction Research Study Groups: Self-Supporting Nasopharyngeal Airway (ssNPA), Standard of Care
Nasal Obstruction Clinical Trial 2023: Self-Supporting Nasopharyngeal Airway (ssNPA) Highlights & Side Effects. Trial Name: NCT05527652 — N/A
Self-Supporting Nasopharyngeal Airway (ssNPA) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05527652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently any open opportunities for enrollment in this trial?

"As evidenced by clinicaltrials.gov, this study is open for patient enrollment. It was initially opened on November 4th 2022 and its most recent update occurred six days later."

Answered by AI

What is the sample size for this clinical research endeavor?

"Affirmative. The records housed on clinicaltrials.gov affirm that this medical research, which was inaugurated on November 4th 2022, is still open for recruitment purposes. 40 participants are sought from a single centre of care."

Answered by AI

What are the primary goals that this clinical experiment is aiming to achieve?

"The primary outcome of this medical trial, measured for a period of up to 16 weeks, is tolerance towards the Self-Supporting Nasopharyngeal Airway (ssNPA). Secondary objectives include sleep quality as calculated by parent report on a scale from 0 to 5 with higher scores indicating improved sleep quality; daytime sleepiness assessed through the Children's Epworth Sleepiness Scale that can range between 0 and 24 points where lower values point at better outcomes; and finally Quality of Life employing dimensions such as Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. The Psychosocial Health Summary Score is derived from"

Answered by AI

Are individuals over 20 years old eligible for enrollment in this research project?

"Participants who wish to enroll in this experiment must be between the ages of 3 and 21. For context, there are 68 clinical trials available for minors while 260 exist for senior citizens."

Answered by AI

Are there any particular criteria that make someone an ideal subject for this research?

"Patients with hypertonia and muscle issues that fall in the 3-21 year age bracket can sign up for this trial. 40 participants are being recruited alltogether."

Answered by AI
~25 spots leftby Aug 2026