Nasopharyngeal Airway for Sleep Apnea

Overseen By Zahra Nourmohammadi

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Anticoagulants

Disqualifiers: Non-compliance, COVID-19, Tracheobronchomalacia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and manageability of a nasal airway device for treating sleep apnea in children. It focuses on those diagnosed with obstructive sleep apnea (OSA) who experience symptoms such as frequent snoring or daytime sleepiness. The device, known as a self-supporting nasopharyngeal airway (ssNPA), helps keep the airway open during sleep. Children who participated in earlier related studies and are willing to continue using the device make good candidates for this trial. As an unphased trial, it provides a unique opportunity for participants to contribute to the understanding and improvement of treatments for pediatric sleep apnea.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulative therapy (medications that prevent blood clotting), you may not be eligible to participate.

What prior data suggests that this nasal airway device is safe for children with hypotonic upper airway obstruction?

Research shows that the self-supporting nasopharyngeal airway (ssNPA) device is generally easy to use. Studies have found that this device can significantly alleviate sleep apnea symptoms, particularly for those who might otherwise require more invasive treatments. It is well-tolerated by individuals with low muscle tone, allowing most users to experience minimal issues or side effects. Although a few users reported a decrease in quality of life due to the device, such cases are rare. Overall, the ssNPA is considered safe for long-term management of obstructive sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for sleep apnea, which often involve bulky machines like CPAP (Continuous Positive Airway Pressure) devices, the Self-Supporting Nasopharyngeal Airway (ssNPA) offers a less intrusive alternative. This device is designed to be used comfortably over long periods, up to 24 months, potentially leading to better adherence and convenience for users. Researchers are excited about ssNPA because it provides a novel way to keep the airway open without the need for masks or extensive equipment, making it a promising option for those who struggle with or prefer to avoid traditional therapies.

What evidence suggests that this nasal airway device is effective for sleep apnea?

Research shows that the Self-Supporting Nasopharyngeal Airway (ssNPA) device, used by participants in this trial, may help treat obstructive sleep apnea (OSA). Studies have found that people can use the ssNPA device comfortably and that it effectively reduces the Apnea/Hypopnea Index (AHI), which measures breathing interruptions during sleep. For children with pharyngeal hypotonia, a condition that weakens throat muscles, the ssNPA has been especially helpful. Early results indicate that it provides quick relief from blocked airways and significantly reduces symptoms. This suggests that the ssNPA could be a useful option for managing sleep apnea in children with certain airway problems. ^{1 4 6 7 8}

Who Is on the Research Team?

Louise M O&#39;Brien, PhD, MS

Principal Investigator

University Michigan

Are You a Good Fit for This Trial?

This trial is for children with muscle hypotonia causing upper airway obstruction, leading to issues like obstructive sleep apnea. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I have been diagnosed with sleep apnea.

I often snore, feel sleepy during the day, or have trouble paying attention.

My tonsils are not enlarged beyond a moderate size.

Exclusion Criteria

Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above

I need medication to prevent blood clots.

I have a bleeding disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the self-supporting nasopharyngeal airway (ssNPA) device to treat obstructive sleep apnea

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

• Self-Supporting Nasopharyngeal Airway (ssNPA)

Trial Overview The study focuses on the long-term effectiveness of a device called ssNPA in treating obstructive sleep apnea caused by hypotonia. It aims to understand how well this nasal airway device works over an extended period.

How Is the Trial Designed?

Group I: Self-Supporting Nasopharyngeal Airway (ssNPA) Experimental Treatment 1 Intervention

Participants will use the device up to 24 months.

Self-Supporting Nasopharyngeal Airway (ssNPA) is already approved in United States, European Union for the following indications:

Approved in United States as Self-Supporting Nasopharyngeal Airway for:

• Obstructive Sleep Apnea in children with Hypotonic Upper Airway Obstruction

Approved in European Union as Self-Supporting Nasopharyngeal Airway for:

• Upper Airway Obstruction in children with hypotonia

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

The new self-retaining nasopharyngeal airway was tested in 100 patients during anesthesia with spontaneous respiration, demonstrating its clinical effectiveness.

In addition to its intended nasal use, the airway can also function as a self-retaining oropharyngeal airway, expanding its versatility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cuffed pharyngeal airway. Feldman, SA., Fauvel, NJ., Ooi, R.[2007]

In a study of 216 patients with rhinogenous obstructive sleep apnea hypopnea syndrome (OSAHS), the use of a nasopharyngeal airway (NPA) post-surgery significantly improved symptoms like nasal obstruction and pain compared to those who did not receive NPA, indicating its efficacy in enhancing patient comfort.

The NPA not only alleviated discomfort but also improved vital signs such as oxygen saturation and blood pressure, demonstrating its safety and effectiveness in maintaining airway patency and hemodynamic stability after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative application of nasopharyngeal airway in rhinogenous obstructive sleep apnea hypopnea syndrome patients]. Zhao, Y., Guo, J., Wu, W., et al.[2014]

In a study involving 34 soldiers, the Supraglottic Airway Laryngopharyngeal Tube (S.A.L.T.) demonstrated the lowest volume of air entering the stomach during ventilation, making it a safer option compared to the oropharyngeal airway (OPA) and nasopharyngeal airway (NPA).

The OPA had the fastest insertion time at 9.34 seconds, which could be crucial in battlefield situations, while the S.A.L.T. took an average of 12.44 seconds, indicating a trade-off between speed and safety in airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of supraglottic airway laryngopharyngeal tube, oropharyngeal and nasopharyngeal airway use by Polish soldiers on the manikin with difficult airway. Kluj, P., Gaszyński, T.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05527652?term=zopf&page=2&rank=15

Self-Supporting Nasopharyngeal Airway (ssNPA) Treating ... The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2212827120300664

Self-Supported Nasopharyngeal Airway Device for ... Results show that ssNPA has demonstrated the good tolerability and feasibility of effectively treating OSA in both patients, and Apnea/Hypopnea Index (AHI) was ...

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

Novel treatment for hypotonic airway obstruction and severe ... Pediatric obstructive sleep apnea (OSA) affects 1–4% of typically developing children and is particularly common in children with pharyngeal hypotonia.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39407808/

Effectiveness of Treating Obstructive Sleep Apnea by ... Surgical interventions and CPAP therapy showed potential long-term effectiveness in managing OSA. Snoring symptoms reappeared about 3.9-5.3 years after ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/00/NCT04846400/Prot_SAP_001.pdf

Pilot Study of a Self-Supporting Nasopharyngeal Airway in ... This patient had immediate relief of his airway obstruction after placement of the ssNPA and the mother reported it led to significant amelioration in symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9516575/

Novel treatment for hypotonic airway obstruction and ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212827120300664/pdf?md5=11d571e4d73be47096e79831ee284959&pid=1-s2.0-S2212827120300664-main.pdf

Self-Supported Nasopharyngeal Airway Device for ... Hypotonic patients may show signs of motor skill delay, along with hypermobile or hyperflexible joints, speech difficulties, poor reflexes, decreased strength,.

8. app.dimensions.ai app.dimensions.ai/details/grant/grant.9848397

Self-Supporting Nasopharyngeal Airway (ssNPA) Treating ... Our multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal airway stent that has demonstrated good tolerability in hypotonic ...