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ssNPA for Obstructive Sleep Apnea (ssNPA Trial)

N/A
Waitlist Available
Led By David A 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

ssNPA Trial Summary

This trial is testing a new device to improve sleep apnea in children, which if successful, could improve quality of life for patients and their families.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Low Muscle Tone
  • Childhood

ssNPA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Ability to Tolerate Measured by Percent of Participants With Protocol Goal
Comfort as Measured by Percent of Participants With Protocol Objective Score
Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal
Secondary outcome measures
Change in Daytime Sleepiness as Shown by Number of Participants Who Had a Reduction in Their Epworth Sleepiness Scale Score
Insertion Protocol Optimization as Measured by Percent of Participants Who Found Insertion Relatively Easy
Sleep Quality, as Measured by Number of Participants With Parent Identified Improved Sleep
+1 more

ssNPA Trial Design

1Treatment groups
Experimental Treatment
Group I: ssNPAExperimental Treatment1 Intervention
self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ssNPA
2021
N/A
~10

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,056 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,497 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,855 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia
David Zopf 2021. "Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04846400.
~1 spots leftby Apr 2025
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