When neurologist and sleep specialist Dr. Kim Hutchison heard that continuous positive airway pressure (CPAP) users were taping their mouths shut, she thought there had to be a better solution.

With the encouragement of her university, she took an entrepreneurial turn in her career and developed the SomnoSeal, a flexible mouthpiece that prevents mouth leaks while on a CPAP. Hutchison developed this device with the help of engineers and the technology transfer office at Oregon Health & Science University (OHSU), where she practices sleep medicine and general neurology.

Today, she is also co-founder and chief medical officer of SomnoSeal Inc., the corporation she established with the help of two business partners. She hopes to have her product on the market by late 2021.

A Problem to Solve

Hutchison has not always thought of herself as an inventor and entrepreneur. A presentation about physician entrepreneurship during a staff meeting changed her mindset.

She realized people who create products don’t always know what problems really need to be solved. Physicians, however, “see the needs of our patients day in and day out,” she said.

CPAP is currently the gold standard treatment for obstructive sleep apnea (OSA). When left untreated, OSA can lead to significant short- and long-term health consequences. Hutchison estimates the condition costs the U.S. billions of dollars annually in associated chronic diseases, accidents, and lost work time.

Indeed, the American Academy of Sleep Medicine estimated in 2016 that the annual economic burden of undiagnosed sleep apnea among U.S. adults is approximately $149.6 billion.

CPAP devices deliver pressurized air to the back of the throat to eliminate OSA. CPAP masks come in two broad categories: full face masks (covering the nose and mouth) and nasal masks (covering the nose only). Patients generally prefer the nasal masks due to the smaller size and lower pressure settings.

The problem? The nasal mask doesn’t work well if a patient is a “mouth breather.” Those patients experience dry mouth and a loss of pressurization. While full-face masks or chin straps offer some help, many patients end up abandoning treatment altogether, she said.

And, when it comes to leaks, many patients try to solve the problem with tape.

Inventing a Remedy

“There are online forums talking about the best tapes to use,” she said. “I even had a patient who was strapping a maxi pad over her mouth at night to try to stop these mouth leaks.”

In 2018 Hutchison received a biomedical innovation program grant from OHSU to creatively solve this mouth leak problem. She spent the next year and a half working with engineers to create some early prototypes. In October 2020 she received a second grant for continued development and in November she filed for a provisional patent.

The specially designed flexible mouthpiece prevents air from blowing out of the mouth. “It allows for a little bit of mouth opening, as well, because forcing the jaw closed can be constricting and problematic for some people,” Hutchison said.

The product is not a treatment for sleep apnea. SomnoSeal is an accessory meant to eliminate mouth leaking during CPAP use. Hutchison is also exploring using the device as a nose-breathing trainer for people who have a problem with snoring.

To learn more about the product and trials, visit the SomnoSeal website.

Special thanks to Kimberly Hutchison, MD, FAASM, Associate Professor of Neurology and Sleep Medicine at Oregon Health & Science University in Portland, Oregon. You can learn more about her on her website.