Most oral appliances for OSA pull the jaw forward. New technologies aim to treat more obstruction sites—and more patients.

By Lisa Spear

Key Takeaways:

• Traditional oral appliances rely on mandibular advancement alone, which often fails to address multilevel airway obstruction in OSA.
• Newer oral appliances incorporate additional mechanisms—such as vertical and lateral jaw movement, tongue stabilization, and nasal dilation—to enhance effectiveness.
• Some of the companies designing the next generation of oral appliances are AIOMEGA, ProSomnus, Open Airway Dental Solutions, Dream Systems, and Vivos Therapeutics.

Oral appliances for obstructive sleep apnea (OSA) typically work by shifting the lower jaw forward. Now, some experts say the devices can be improved by adding other mechanisms of action alongside mandibular advancement. If successful, the next generation of oral appliances could benefit far more patients than the devices of today.

Today, about one-third of patients experience no therapeutic benefit with an oral appliance.¹ One likely reason is that obstruction in OSA often happens at multiple points throughout the airway. 

“The airway is not just a flat piece of paper that you can move forward. It’s a tube,” says Raghavendra Ghuge, MD, DABSM, MBA, founder of AIOMEGA, which markets several oral appliances. “Everyone has attempted to move the jaw forward as an attempt to open the airway. The problem with that concept is that it is flawed,” says Ghuge.

Ghuge and others are proposing new solutions. In the case of AIOMEGA’s AIOBreathe oral appliance, it permits anterior, vertical, and lateral jaw movements and is designed to maintain an open airway by 1) anterior advancement of the mandible and tongue, 2) throughout opening and closing movements of the mouth, and 3) throughout lateral movements of the mandible, according to its US Food and Drug Administration (FDA) 510(k) clearance.

Plateaus on the right and left occlusal cranial surfaces of the lower tray guide the mandible downward, opening the anterior airway. Together with curved flanges that allow vertical opening of the jaw, the design elements maintain advancement in open and closed mouth positions and create traction for the tongue to migrate forward. The resulting mechanical protrusion acts to increase the patient’s pharyngeal space, Ghuge says.

“We have built devices that allow you to open the airway of an individual larger than their natural size. This is a new concept,” he says.

Meanwhile, ProSomnus launched a new device this year, the ProSomnus EVO Guided, which dilates the velopharynx and the oropharynx. It boasts an “incomplete dental overlay” feature, meaning it does not extend onto the inner surface of the teeth. This design, unlike traditional mandibular advancement devices, does not obstruct the tongue’s movement, enhancing airway opening, says John E. Remmers, MD, chief scientist at ProSomnus Sleep Technologies.

EVO Guided is designed to stabilize and titrate the mandible into the prescribed therapeutic position, guide the tongue to a beneficial anterior position, and guide the mouth closed, according to ProSomnus.

Traditional oral appliance therapy design also overlooks the potential impact of nasal obstruction, says Sat Sharma, MD, FRCPC, FCCP, FACP, FAASM, medical director of the Centre for Sleep and Chronobiology and chief medical officer of Open Airway Dental Solutions, which markets oral appliances that address nasal blockages.

Oral appliance therapy targets the tongue base and resistance in the soft palate and epiglottis. But, “by not treating the entire upper airway, traditional mandibular advancement device therapy remains ineffective for certain individuals,” says Sharma.

If the oral appliance, for instance, does not allow the patient to open their mouth while sleeping, their OSA might become worse if they have a blocked nose.

In this case, the nasal blockage should be addressed as well, especially since high nasal resistance is observed in over 70% of patients with OSA and is linked with oral appliance failures.²

“When mouth breathing occurs as a response to increased nasal resistance or negative pressure swings, the base of the tongue collapses (hypoglossal collapse) and the lack of oral seal leads to dry mouth and other dental issues,” Sharma says. “These situations with nasal congestion or obstruction and multiple levels of collapse, such as nasopharyngeal, soft palate- and lateral wall-collapse, cannot be addressed effectively by simply bringing the jaw forward that occurs with the traditional” mandibular advancement devices.

Open Airway Dental Solutions’ O2Vent Optima aims to address nasal resistance. An air vent in the device protrudes from the front of the mouth. That way, if the nose is blocked, the patient can breathe through their mouth.

In Canada, the O2Vent Optima also comes with an expiratory positive airway pressure (EPAP) accessory that is inserted inside the front vent. When the patient is breathing through the airway, the “ExVent” flapper-type valve fully opens during inhalation and closes upon exhalation, with airflow directed through “holes” in the valve, providing EPAP. The ExVent valves are currently being reviewed by the FDA for 510K clearance. (The O2Vent devices with the air channel are FDA cleared and commercially available in the United States.) 

Another issue the traditional oral appliance does not address is tongue position. Even with an oral appliance, the tongue can slip back, obstructing breathing.

With a multi-pronged approach to open the airway, Dream Systems’ OASYS Oral/Nasal Airway System, holds the tongue in place. It uses mandibular advancement and nasal dilation together. The OASYS includes extensions, little paddles that branch off the device to act as nasal dilators inside the mouth. The dilators are designed to prop the nasal valve open and improve the middle region of the nasal airway bilaterally.     

Palate expansion is another method that is employed by at least one oral appliance company, Vivos Therapeutics.

As the only oral appliance currently FDA cleared for severe OSA (it’s also cleared for mild to moderate), the Vivos devices don’t need to be worn for the duration of a patient’s life, says R. Kirk Huntsman, cofounder and CEO of Vivos. The alveolar ridge, the bony ridge of the upper and lower jaws that contains the tooth sockets, is expanded in months and then the patient can discontinue use of the device.

“If we are trying to manage a disease, traditional mandibular advancement is perfectly fine,” Huntsman says. “But if we are really trying to get rid of the disease, and we are really trying to improve the structure of the human body, which will allow for normal breathing and restoration of normal breathing during sleep, then we have to affect the alignment of the airway.”

These emerging therapies mark a shift from mechanical repositioning to precision airway management—reshaping the goals and potential of oral appliance therapy.

References

1.Sutherland K, Vanderveken OM, Tsuda H, et al. Oral appliance treatment for obstructive sleep apnea: an update. J Clin Sleep Med. 2014;10(2):215-27.

2. Tong BK, Tran C, Ricciardiello A, et al. Efficacy of a novel oral appliance and the role of posture on nasal resistance in obstructive sleep apnea. J Clin Sleep Med. 2020 Apr 15;16(4):483-92.

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