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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Self-Supporting Nasopharyngeal Airway (ssNPA) for sleep apnea?

Research shows that using a nasopharyngeal airway can help treat obstructive sleep apnea by keeping the airway open during sleep, reducing snoring and breathing interruptions. Similar devices, like the nasopharyngeal prong airway and nasal airway stent, have been effective in managing sleep apnea and related breathing issues. ^{1 2 3 4 5}

Is the nasopharyngeal airway safe for use in humans?

Research shows that the nasopharyngeal airway has been used safely in patients recovering from anesthesia and in those with sleep apnea, with monitoring of vital signs to ensure safety. ^{3 6 7 8 9}

How is the Self-Supporting Nasopharyngeal Airway (ssNPA) treatment different from other sleep apnea treatments?

The Self-Supporting Nasopharyngeal Airway (ssNPA) is unique because it is a self-retaining device designed to keep the airway open during sleep by being inserted through the nose, unlike the more common CPAP machines that use external pressure to maintain airway patency. This makes it a potentially less intrusive option for those who find CPAP uncomfortable. ^{2 3 5 10 11}

What is the purpose of this trial?

This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.

Research Team

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

Principal Investigator

University Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

The nasopharyngeal prong airway: an effective post-operative adjunct after adenotonsillectomy for obstructive sleep apnoea in children. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The efficacy of nasal airway stent (Nastent) on obstructive sleep apnoea and prediction of treatment outcomes. [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Postoperative application of nasopharyngeal airway in rhinogenous obstructive sleep apnea hypopnea syndrome patients]. [2014]

4. China pubmed.ncbi.nlm.nih.gov

[One night treatment of obstructive sleep apnea and hypopnea syndrome with nasopharyngeal airway]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The cuffed pharyngeal airway. [2007]

6. China pubmed.ncbi.nlm.nih.gov

[The application of nasopharyngeal airway in nurosurgery patients during anesthesia recovery]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

An algorithm for the sedation of patients with obstructive sleep apnea by non-anesthesiologists. [2021]

8. Poland 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. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Risk of interrupting nocturnal nasal continuous positive airway pressure (nCPAP) in patients with obstructive sleep apnea]. [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Hypopharyngeal airway surgery. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A feasibility study in the treatment of obstructive sleep apnea syndrome and snoring: Nasopharyngeal stent. [2021]