For the estimated 54 million Americans with obstructive sleep apnea, bedtime isn't refreshing. Their airways are partially blocked during sleep, leading to daytime grogginess and lasting health problems. Continuous positive airway pressure, or CPAP, treatment can be effective, but about half of users quit, citing factors like discomfort, stress, and cost. To help more people sleep safely, a team of Johns Hopkins alumni is developing a lightweight sleep apnea treatment device that is as easy to wear as a retainer.
When Sleep Isn't Sound
While training in otolaryngology–head and neck surgery in Australia, Somnair Sleep co-founder and CEO Anders Sideris, Engr '23 (MSE), saw how sleep apnea harmed patients. Over the course of the night, people with sleep apnea can snore, gasp for air, or stop breathing more than five times per hour for 10+ seconds each time. They face an increased risk of chronic diseases like heart disease and diabetes. CPAP treatment opens airways through a pressurized mask worn at night, but many people can't tolerate the bulky mask or the dry air flowing through it. When CPAP fails, the next step is often highly invasive surgery to correct airway obstruction.
At Johns Hopkins, Sideris met co-founders Mitchell Turley, Engr '23 (MSE); Phoebe Dijour, Engr '23 (MSE); and Shri Prabha Shivram, Engr '23 (MSE). They shadowed ear, nose, and throat surgeons and observed patients who struggled with CPAP but were unable or unwilling to undergo surgery. They spent over 1,000 hours listening to physicians and patients, determined to find a solution for the patients' unmet needs.
"We were able to bounce ideas off each other from different perspectives to develop this idea: a noninvasive treatment for the disorder that specifically serviced those patients that had no other option," says Sideris, a President's Venture Fellow.
The team ultimately found a flash of inspiration when scouring anatomy textbooks. They zeroed in on a nerve that controls muscle activity in the palate and throat and leads to airway opening when stimulated. "We realized that there's this one target that hasn't been tried before—and it's accessible, noninvasively, in the mouth," Sideris says.
A New Approach
The Somnair Sleep team's device stimulates the target nerve to open a user's blocked airway. The wearer places the retainerlike device inside their mouth at bedtime. Within the device is a circuit that applies stimulation, similar to a muscle stimulator used to reduce muscle pain after exercise.
"While the patient's sleeping, it's gently providing that stimulation in order to maintain the airway opening as they're trying to breathe in," Turley says.
The team is conducting a proof-of-concept study with Johns Hopkins School of Medicine physicians Luu Van Pham and Kevin M. Motz. Early results in 22 patients appear to validate their hypothesis that the device opens airways in patients who aren't tolerating CPAP.
Reaching Patients in Need
The Somnair Sleep team is now pitching its product to investors and incubators.
Johns Hopkins Technology Ventures and the Pava Marie LaPere Center for Entrepreneurship have linked Somnair Sleep with resources to help with the complexities of launching and growing a medical device business, from technical development to regulatory planning.
"The growing entrepreneurship community at Hopkins and in Baltimore as a whole has been extremely helpful, both in terms of connections for the company as well as providing a supportive community," Turley says.
The team's goal is to obtain FDA approval for the device so they can market it to patients in need.
"We care about patients and reducing the suffering that they experience each night. We want to provide them an option that they want to use, they want to wear, and that would simplify their lives and even the lives of their partners," Turley says.
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