ssNPA Device for Upper Airway Obstruction

Overseen By Louise M O'Brien, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Anticoagulants

Disqualifiers: Severe autism, Airway collapse, 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: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new device, the Self-Supporting Nasopharyngeal Airway (ssNPA), for children with obstructive sleep apnea due to Hypotonic Upper Airway Obstruction (HUAO). The researchers aim to determine if this device can alleviate common symptoms such as snoring, daytime sleepiness, or hyperactivity. Participants will either use the ssNPA device or continue with their usual care while awaiting another treatment option. Children who have had their tonsils removed or cannot undergo this surgery, yet still experience significant sleep issues, may be suitable candidates. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from an innovative treatment option.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the ssNPA device is safe for treating upper airway obstruction in children?

Research shows that the Self-Supporting Nasopharyngeal Airway (ssNPA) device is generally safe for treating breathing problems in people with low muscle tone. In earlier studies, patients using the ssNPA device did not report any serious side effects. Some individuals might worry about comfort, as it may feel strange initially. However, no major safety issues have emerged.

The device helps keep the airway open during sleep and is especially aimed at children with obstructive sleep apnea, a condition where breathing stops and starts during sleep. Although data is limited, available research suggests that most patients can use the ssNPA device without significant problems.

Overall, the ssNPA device appears to be a safe option, but discussing any concerns with a healthcare provider is important. They can offer advice based on individual needs and conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Self-Supporting Nasopharyngeal Airway (ssNPA) is unique because it offers an innovative approach to managing upper airway obstruction, differing significantly from standard treatments like positive airway pressure (PAP) devices. Unlike traditional options that rely on external machines to maintain airflow, the ssNPA is a self-supporting device, which means it physically keeps the airway open without the need for external power or machines. Researchers are excited about this treatment because it could provide a more convenient and less cumbersome solution for patients, potentially improving compliance and comfort. Furthermore, ssNPA’s simple design allows for easier use, making it particularly promising for individuals who struggle with complex equipment.

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

Research shows that the Self-Supporting Nasopharyngeal Airway (ssNPA) device, which participants in this trial may receive, can help treat obstructive sleep apnea (OSA), a condition where the airway blocks during sleep. Studies have found that the ssNPA device can lower the Apnea/Hypopnea Index (AHI), which measures the severity of sleep apnea. Patients report that the device is comfortable and easy to use, making it a good option for those with weakened upper airway muscles. The ssNPA could serve as an alternative to more invasive treatments like surgery or a tracheostomy. Although not widely used yet, early research suggests it can be a useful tool for managing airway blockage. ^{1 2 4 6 7}

Who Is on the Research Team?

David Zopf, MD

Principal Investigator

The University of Wisconsin

Louise O'Brien, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for children with Hypotonic Upper Airway Obstruction and obstructive sleep apnea who've had a tonsillectomy or can't have one. They must show symptoms like snoring, daytime sleepiness, or hyperactivity. Kids with severe breathing issues during sleep, bleeding disorders, certain airway collapses, active COVID-19 infection, or those on blood thinners cannot join.

Inclusion Criteria

I experience symptoms like snoring, daytime sleepiness, or hyperactivity.

My child has severe sleep apnea or breathing issues at night confirmed by a sleep study.

I have had my tonsils removed or cannot have them removed due to health reasons.

Exclusion Criteria

I have a lung condition that restricts my breathing.

I have a medical condition that makes using a nasal airway support unsuitable.

You have a medical or social situation that could make it hard for you to follow the study plan or attend follow-up appointments. Some psychiatric conditions, like ADHD or conduct disorder, won't be excluded, but severe autism will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants are placed on a waitlist for positive airway pressure (PAP) for 8 weeks

8 weeks

Treatment

Participants receive the Self-Supporting Nasopharyngeal Airway (ssNPA) device

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-Supporting Nasopharyngeal Airway (ssNPA)

Trial Overview The study tests if the Self-Supporting Nasopharyngeal Airway (ssNPA) device helps treat obstructive sleep apnea in kids with muscle hypotonia affecting their upper airways. It's an alternative to traditional treatments post adenotonsillectomy.

How Is the Trial Designed?

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

Group II: Standard of Care Active Control 1 Intervention

Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The oropharyngeal airway (OPA) is generally considered a safe device for aiding in mask ventilation, having been used since 1933.

However, there is a rare risk of aspiration leading to severe complications, such as near total upper airway obstruction, highlighting the need for careful placement and monitoring during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration of an oropharyngeal airway during nasotracheal intubation. Lee, CM., Song, KS., Morgan, BR., et al.[2022]

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]

The study found that reduced upper airway dimensions during sleep are linked to lower sleep efficiency, highlighting the importance of airway size in sleep quality.

The nasopharyngeal appliance (NPA) was shown to be more effective than the mandibular repositioning splint (MRS) in improving outcomes for patients with upper airway resistance syndrome (UARS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper airway dimensions and sleep efficiency--three-dimensional imaging analysis and assessment of the nasopharyngeal appliance. Venkat, R., Vasanthakumar, M., Balakrishnan, D., et al.[2015]

In a study of 413 infants, the length of the artificial nasopharyngeal airway measured endoscopically (from nostril to vocal cord) closely matched the anthropometric measurement (from nose tip to earlobe), indicating that both methods can be used effectively to determine airway length.

There is a strong correlation between the endoscopic measurement and factors such as body length, body weight, and age, suggesting that these anthropometric measurements can reliably guide the proper insertion length for nasopharyngeal airways in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasopharyngeal tract length measurement in infants. Shen, CM., Soong, WJ., Jeng, MJ., et al.[2015]

In a study of 18 patients with obstructive sleep apnea (OSA) undergoing uvulopalatopharyngoplasty (UPPP), those with narrowing only in the nasopharynx (ENP group) showed an 86% improvement in respiratory disturbances after surgery, compared to only 18% in those with narrowing at other sites (NENP group).

The findings suggest that assessing the mechanics of the passive pharyngeal airway can help predict which patients are more likely to benefit from UPPP, highlighting the importance of identifying specific narrowing locations in the airway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Site of pharyngeal narrowing predicts outcome of surgery for obstructive sleep apnea. Launois, SH., Feroah, TR., Campbell, WN., et al.[2013]

A new type of nasal prong for administering nasal continuous positive airway pressure (N-CPAP) therapy has been used safely and effectively in infants with decreased lung compliance, improving their lung function without the need for intubation.

The new nasal prongs address issues related to fixation and potential nasal injuries caused by traditional prongs, indicating a safer option for delivering N-CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience in using a new type of nasal prong for administration of N-CPAP. So, BH., Shibuya, K., Tamura, M., et al.[2019]

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]

A case study highlighted that nasopharyngeal airways (NPAs) can be retained in patients for multiple days, leading to recurrent upper airway obstruction, which is a rare but serious complication.

Using larger-flanged NPAs may help prevent displacement into the nasal cavity, and the study emphasizes the importance of clear communication between emergency medical services and emergency department staff to ensure all inserted devices are accounted for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Notable Complication of Nasopharyngeal Airway: A Case Report. Briggs, B., Countryman, C., McGinnis, HD.[2020]

The nasopharyngeal prong (NPP) is an effective, non-invasive solution for alleviating upper airway obstruction in children with craniofacial disorders, particularly in those with Robin sequence, where a small jaw and retrognathia can block the airway.

The NPP serves as a temporary measure that can help maintain airway patency while allowing for natural mandibular growth, potentially reducing the need for more invasive surgical interventions in selected cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the nasopharyngeal prong in craniofacial disorders in particular the Pierre Robin sequence. Abel, F., Wallis, C.[2022]

The nasopharyngeal airway is an effective and minimally invasive tool for managing upper airway obstruction, making it suitable for use by various healthcare professionals.

The authors present a quick and practical method for securing a nasopharyngeal airway using safety pins and tape, which has proven effective in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Securing a nasopharyngeal airway. Bajaj, Y., Gadepalli, C., Knight, LC.[2022]

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]

While nasopharyngeal airways are generally safe and effective for bypassing upper airway obstructions, this case highlights the potential for significant nasal trauma, such as middle turbinate avulsion, when used in unconscious patients.

The report emphasizes the risks associated with multiple attempts at nasal intubation in patients with altered consciousness, suggesting that careful consideration and technique are crucial to avoid complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal foreign body after attempted nasal intubation: a case of traumatic middle turbinectomy. Scott, AR., Gray, ST.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04846400

Pilot Study of a Self-Supporting Nasopharyngeal Airway in ... OSA is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep with associated arousals and/ or oxygen desaturations.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35866230/

Novel treatment for hypotonic airway obstruction and ... A long-term NPA device may be an alternative or temporizing option to continuous positive airway pressure, upper airway surgery, or tracheostomy.

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

Pilot Study of a Self-Supporting Nasopharyngeal Airway in ... Although an NPA is shown to be safe and effective, very few patients currently receive the treatment due to the perceived decrease in quality-of-life for the ...

5. reporter.nih.gov reporter.nih.gov/project-details/10215146

zopf, david adam - NIH RePORTER Our multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal airway stent that has demonstrated good tolerability in hypotonic ...

6. 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,.

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

Novel treatment for hypotonic airway obstruction and ... Two patients used a safety pin and tape attachment, and two patients used a novel 3D-printed, self-supporting nasal securement. All 4 patients had ...