Nasopharyngeal Airway for Obstructive Sleep Apnea

Recruiting at 1 trial location

Overseen By Louise M O'Brien, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Non-compliance with NPA-OSA device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on a device designed to help people with obstructive sleep apnea, a condition where breathing repeatedly stops and starts during sleep. The goal is to allow participants from the original study to continue using the nasopharyngeal airway device at home and track its long-term effects. Participants will maintain contact with the study team and complete sleep-related questionnaires over a year. Only those who completed the initial study and used the device as directed can join this follow-up trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve sleep apnea treatments for others.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the nasopharyngeal airway device is safe for obstructive sleep apnea?

Research has shown that nasopharyngeal airway devices, used to treat obstructive sleep apnea (OSA), yield mixed results in terms of safety and effectiveness. Some studies indicate these devices can help with severe OSA and offer an alternative to more invasive procedures like a tracheostomy, a surgical opening in the neck to assist with breathing. However, other studies suggest that not everyone finds these devices comfortable.

People with OSA already face a higher risk of breathing problems, and using a nasopharyngeal airway device can sometimes increase this risk.

While the device might help some individuals, it's crucial to consider the potential side effects. Prospective trial participants should discuss these factors with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for obstructive sleep apnea (OSA) involve devices like CPAP machines or surgical interventions to keep airways open during sleep. However, the nasopharyngeal airway device is unique because it offers a less invasive solution by using a simple airway tube to maintain open air passages. This new approach is exciting because it can be used at home comfortably over two years, potentially improving adherence and effectiveness compared to more cumbersome existing devices. Researchers are eager to see if this straightforward yet innovative device can provide a more user-friendly and effective alternative for managing OSA.

What evidence suggests that the nasopharyngeal airway device is effective for obstructive sleep apnea?

Research shows that a device called a nasopharyngeal airway can lessen the severity of obstructive sleep apnea (OSA), especially in severe cases. In this trial, participants will use the nasopharyngeal airway device at home for two years. Some studies have found significant improvements in people using this type of device, even when compared to treatments like tracheostomy. However, the device's effectiveness can vary; about 30% of people with mild-to-moderate OSA did not tolerate similar devices well. This device keeps the airway open during sleep, reducing snoring and improving breathing. While results are promising for some, individual experiences with the device can differ. ^{2 6 7 8 9}

Who Is on the Research Team?

Louise M O'Brien, PhD

Principal Investigator

University of Michigan

David Zopf, MD, MS

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals who have been part of the parent study (NCT06677151) and are using a nasopharyngeal airway device to manage Obstructive Sleep Apnea Syndrome. Participants will continue using the device and have follow-ups with their doctors.

Inclusion Criteria

I finished the initial study and want to keep using the NPA-OSA device.

Exclusion Criteria

Participants who were non-compliant with the NPA-OSA device during their participation in the parent study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the nasopharyngeal airway device for obstructive sleep apnea at home

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of sleep questionnaires

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Nasopharyngeal Airway

Trial Overview The trial is testing long-term use of a nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device in patients from an earlier study. It involves regular check-ins with the study team and clinical follow-up, plus sleep questionnaires at 12 months.

How Is the Trial Designed?

Group I: Nasopharyngeal airway device Experimental Treatment 1 Intervention

A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for two years at home.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Wallace H Coulter Center for Translational Research

Collaborator

Trials

2

Recruited

40+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25544266/

Nasopharyngeal airway stenting devices for obstructive ... Conclusion: Some studies have demonstrated limited effectiveness and low tolerability of nasopharyngeal airway stenting devices, while other studies have shown ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07191314

Long-term Evaluation of a Nasopharyngeal Airway A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for two years at home. Intervention/Treatment, Device : nasopharyngeal airway ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10202

Novel treatment for hypotonic airway obstruction and severe ... Use of an NPA device demonstrates a significant improvement in severity of OSA for patients with severe OSA who otherwise would have pursued tracheostomy or ...

4. karger.com karger.com/res/article/100/3/193/285294/The-Effectiveness-of-Nasal-Airway-Stent-Therapy

The Effectiveness of Nasal Airway Stent Therapy for ... Conclusions: NAS therapy reduced severity and snoring in patients with mild-to-moderate OSAS. Approximately 30% of patients did not tolerate NAS ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725003120

Efficacy of high-flow nasal cannula therapy and its ... A significant improvement in the OSA-18 scores with both HFNC and CPAP therapy compared to baseline was demonstrated. However, HFNC therapy did not provide ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06677151

Study Details | NCT06677151 | NPA-OSA Device ... This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224001333

Adverse events in patients with obstructive sleep apnea ... The odds of respiratory adverse events were significantly increased for patients with OSA (OR 1.65, 95 % CI 1.03–2.66, P = 0.04). Furthermore, the odds of ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22003339/

Long-term use of a nasal expiratory positive airway ... Nasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment.

9. cambridge.org cambridge.org/core/journals/journal-of-laryngology-and-otology/article/nasopharyngeal-airway-stenting-devices-for-obstructive-sleep-apnoea-a-systematic-review-and-metaanalysis/0F663D198087EC0747EB54C385B68760

Nasopharyngeal airway stenting devices for obstructive ... Some studies have demonstrated limited effectiveness and low tolerability of nasopharyngeal airway stenting devices, while other studies have ...