Long-term Evaluation of a Nasopharyngeal Airway for Obstructive Sleep Apnea

This study is looking at the long-term use of a device called the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device. This device is a flexible, silicone tube that you insert into your nostril before sleep to help with snoring and obstructive sleep apnea (when breathing repeatedly stops and starts during sleep). The study wants to see how well the NPA-OSA device continues to reduce the severity of your sleep apnea over 24 months. You can join this study if you previously participated in the parent study (HUM00179497) and want to keep using the NPA-OSA device. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study, meaning you will receive a specific treatment. It is a long-term follow-up study for participants who completed a previous study.
What's involved
You will continue using the NPA-OSA device. The study team will stay in contact with you as needed, and you will have clinical follow-up with your doctor. At 12 months, you will complete sleep questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the change in sleep apnea severity at 24 months, indicating a follow-up period of at least two years.

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NCT07191314

Long-term Evaluation of a Nasopharyngeal Airway

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~20 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in severity of apnea hypopnea index (AHI)
Measured over Baseline (day 0), 24 months
Sleep Apnea, Obstructive
2 sites across 1 states
Michigan2
  • Louise M O'Brien, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • David Zopf, MD, MS · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.

Exclusion

The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
  • Change in severity of apnea hypopnea index (AHI)Baseline (day 0), 24 months

    The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.