Self-Supporting Nasopharyngeal Airway (ssNPA) for Hypertonia, Muscle

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Michigan, Ann Arbor, MI
Hypertonia, Muscle+12 More
Self-Supporting Nasopharyngeal Airway (ssNPA) - Device
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Obstructive Sleep Apnea (OSA)
  • Hypertonia, Muscle
  • Down Syndrome (DS)
  • Nasal Airway Obstruction
  • Down Syndrome
  • Tolerance

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 16 weeks

Up to 16 weeks
Apnea-hypopnea index (AHI)
Daytime sleepiness
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Sleep quality
Snoring frequency

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Self-Supporting Nasopharyngeal Airway (ssNPA)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Self-Supporting Nasopharyngeal Airway (ssNPA) · No Placebo Group · N/A

Self-Supporting Nasopharyngeal Airway (ssNPA)
Device
Experimental Group · 1 Intervention: Self-Supporting Nasopharyngeal Airway (ssNPA) · Intervention Types: Device
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 16 weeks
Closest Location: The University of Michigan · Ann Arbor, MI
Photo of ann arbor 1Photo of ann arbor 2Photo of ann arbor 3
2010First Recorded Clinical Trial
1 TrialsResearching Hypertonia, Muscle
38 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,915,149 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,517 Total Patients Enrolled
University of MichiganLead Sponsor
1,597 Previous Clinical Trials
6,329,017 Total Patients Enrolled
David Zopf, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Children with hypotonic upper airway obstruction (HUAO) should undergo polysomnography to determine the presence of obstructive sleep apnea (OSA).
All subjects require the presence of at least one symptom of OSA.
You have a history of tonsillectomy.
Tonsil size 2 or smaller.
Parent/caregivers and child are willing and able to provide informed consent and assent, where appropriate.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.