An estimated 40 million adults in the United States have obstructive sleep apnea (OSA), a chronic sleep-related breathing disorder that involves a decrease or complete halt in airflow. Continuous positive airway pressure (or CPAP) is broadly considered first-line therapy for OSA.
CPAP technology is effective, but only if used regularly. Largely due to discomfort related to the mask and associated headgear required to maintain prescribed airway pressures by current devices, today's CPAP is not well tolerated by patients. Noncompliance is estimated to impact at least a third of patients.
Researchers at the University of Cincinnati are developing a VortexPAP machine that takes advantage of vortex airflow technology. A preliminary clinical study with current CPAP users demonstrated that the VortexPAP can deliver the pressure levels that are used in the subjects' CPAP therapy, but the mask is more comfortable to wear. It has a minimalistic design that is less intrusive and barely touches the patient's face.
"Despite the clinical efficacy for CPAP in controlling OSA, patient compliance with the therapy remains a major cause of treatment failure," says Liran Oren, PhD, research associate professor in the Department of Otolaryngology, Head and Neck Surgery at the UC College of Medicine.
Dr. Liran Oren is shown with Dr. Ephraim Gutmark and Dr. Ann Romaker and the VortexPAP device. Photo by Andrew Higley/UC Marketing + Communications.
"The vast majority of complaints from patients in CPAP therapy revolve around improving the comfort of the mask," explains Oren. "However, regardless of the design, they all require a tight seal over the face, so that the airway can be pressurized. This design requirement for a tight seal is the main limitation for making CPAP therapy more comfortable."
Oren says the VortexPAP eliminates the requirement for a tight seal since it's based on reapplication of vortical airflow, a flow control mechanism commonly used in aerospace engineering application.
"The unique aerodynamic properties of vortical airflow enables the device to pressurize the upper airways without needing a tight-fitting mask," says Oren. "As a result, this game-changing innovation will make CPAP therapy more comfortable, better tolerated and may increase patient compliance, a win for patients, doctors and third-party payers. Over 40 million people in the U.S. are diagnosed with OSA but the actual number is likely even higher because many remain undiagnosed."
The project is a collaboration between Oren; Roy Kulick, MD, UC Entrepreneur-in-Residence; Ephraim Gutmark, PhD, Distinguished Professor, Ohio Eminent Scholar in the UC Department of Aerospace Engineering; and Ann Romaker, MD, director of the UC Sleep Medicine Center and professor in the UC Department of Internal Medicine.
Romaker says the biggest design change is the lack of a need for a seal. The interface will not be tight nor will it have to be enclosed, so people with a degree of claustrophobia will be much more comfortable, as well as everyone else.
"The lower pressures produced by this method will also decrease air swallowing, which can be uncomfortable for some CPAP users and, again, will be more comfortable," Romaker says.
According to Oren, the development work is also done with the goal of eventually commercializing the VortexPAP in the U.S. As such, they received strong support from the UC Venture Lab. They paired with Entrepreneur-in-Residence Kulick, who has been instrumental in helping build out a business plan for the VortexPAP.
"I think this project is the epitome of UC," Oren adds.
Featured image at top of the VortexPAP displayed in the laboratory of Dr. Liran Oren in the UC College of Medicine. Photo by Andrew Higley/UC Marketing + Communications.
