FDA Approves eXciteOSA Tongue Stimulator For Daytime Treatment of Sleep Apnea

Photo from Signifier Medical Technologies

FDA Approves eXciteOSA Tongue Stimulator For Daytime Treatment of Sleep Apnea

By Admin

The U.S. Food and Drug Administration (FDA) approved a new device technology called an intraoral neuromuscular stimulator to help treat snoring and sleep apnea. The product, called eXciteOSA (formerly Snoozeal), is an oral device that uses an electrical charge to stimulate the tongue and strengthen its muscles, which makes the palate less susceptible to snoring or blockage. Created the company Signifier Medical Technologies, the eXciteOSA device is due for release in the coming weeks. One of the main benefits of this device, as its developers point out, is that it can be used during the day hours, which makes it unique among sleep apnea treatments now available. Thus far, the eXciteOSA device has been recommended for mild sleep apnea and snoring, which are serious problems affecting nearly one in three Americans of middle age or older. While this device is marketed as an alternative to PAP therapy and other sleep apnea treatments, it can potentially be used alongside CPAP for those experiencing severe symptoms. Others may wish to supplement their CPAP therapy with something to better target their snoring. Whatever the case, this breakthrough technology is another example of current innovations in sleep-related breathing treatment, a growing sector of the health products market seeking to prevent as well as treat these all-too-common conditions.

The eXciteOSA Concept

The eXciteOSA device is a type of neuromuscular electrical stimulator, or NMES, which uses electrical stimulation inside the mouth to stimulate the palate. This is sometimes referred to as continuous transmucosal electrical stimulation therapy, and it works by sending user-controlled electrical current with defined frequencies (mild charge) to stimulate and improve muscle function. The device is shaped like a prong that fits over the tongue when inserted into the mouth. The tongue slides between the two ends of the prong, which then administer the charges to stimulate the tongue muscles and neural activity. The eXcitteOSA device can be operated using a remote control or with a separate device via the eXciteOSA mobile app, which also provides access to settings and other information. Like an exercise for the tongue, the eXciteOSA stimulator strengthens muscles over time. The device company, Signifier Medical Technologies, recommends using eXciteOSA for 20 minutes a day for six weeks, then twice per week thereafter for best results. Along with daytime use, another selling point of eXciteOSA is its small size and simple design. Small enough to fit in a jacket pocket, the eXciteOSA device uses only three primary components: a mouthpiece, a rechargeable control unit attached to the mouthpiece (via USB), and a remote control unit and smartphone app to manage settings and preferences. The mouthpiece form-fits to palates of any size and includes digital connectivity between patient and provider to allow for remote setup, adjustment, and monitoring.

While the effectiveness of tongue exercises in reducing snoring and sleep apnea symptoms is documented, its use is not considered widespread. Most techniques, such as orofacial myofunctional therapy, or OMT, will utilize household items like spoons or toothbrushes to pressure the tongue into flexed positions, but it takes both time and discipline to maintain long-term adherence to the therapy. Other treatments, for example, hypoglossal nerve stimulation, uses an implanted device to stimulate the nerves automatically, but this requires oral surgery and is normally reserved for more severe cases. The eXciteOSA device uses this concept in an innovative way, making the exercise brief and very easy to perform.

Effectiveness of Treatment

According to the Signifier Medical Technologies Clinical Evidence page, clinical trials of the eXciteOSA device exceeded expectations in a number of areas. For example, most studies found the intraoral NMES technology to be effective for treating snoring and mild obstructive sleep apnea in a majority of patients, including mean reductions in AHI (Apnea Hypopnea Index), snoring time, and EES (Epworth Sleepiness Scale). In fact, the company noted, at least one study found that snoring was reduced at twice the rate of their targeted endpoint of 20 percent.

As the company explains in a recent press release on the eXciteOSA device, early treatment of OSA and snoring can be an effective preventive measure against the development of more serious conditions. According to one of the clinical trial investigators, Atul Malhotra, M.D., Research Chief of Pulmonary, Critical Care and Sleep Medicine at U.C. San Diego Health, “A strong argument can be made that early treatment may be beneficial since the consequences of the condition may become irreversible.” Dr Malhotra goes on to explain how treatment of sleep apnea can be extremely effective when adhered to, and not only improves symptoms but “reduces blood pressure, improves glucose control, and reduces the risk of motor vehicle accidents, among other benefits.” Malhotra calls eXciteOSA an important treatment option for patients with snoring and mild sleep apnea, and the focus on preventive medicine is highly significant in the current climate of a global pandemic. Health consciousness has always been a life-or-death issue, but the pandemic has underscored those concerns, making preventive medicine an immediate concern for everyone.

Awards

For their work on the eXciteOSA device, Signifier Medical Technologies was granted an International Design Excellence Award (IDEA) from the Industrial Designers Society of America (IDSA) in 2020. The award was a bronze “Medical & Health” award for novel technologies in the medical industry. Founded in 1965, Industrial Designers Society of America is one of the oldest industrial design associations in the country, and its awards are given annually to companies with new and innovative developments. In addition to the IDEA award, consulting firm Frost and Sullivan recognized the eXciteOSA concept with a European New Product Innovation Award during its development in 2017. Frost and Sullivan emphasized the product’s effectiveness at early stages of sleep-disordered breathing, as well as its over-the-counter (OTC) status, which could make eXciteOSA more easily accessible than other anti-snoring products on the market.

New Developments in Sleep Disorder Treatment

While many new sleep apnea treatments are marketed as alternatives to CPAP, they are often compatible with PAP therapy as well, giving patients a range of possibilities when addressing sleep disorders in general and sleep-related breathing disorders in particular. As a daytime treatment option, the eXciteOSA device is a good example of this, capable of providing supplementary treatment for snoring and sleep apnea symptoms. While the eXciteOSA device may not be applicable to more severe sleep apnea cases or those with central sleep apnea (CSA), which do not involve blockage of the airway, it does, however, offer a novel approach to chronic snoring and mild or progressive OSA, which is a major focus area for outreach and public-health education campaigns. The more options these individuals have, the more likely they will address the problem in effective and timely manner.