Nearly 40 million Americans have obstructive sleep apnea, according to the Council on Aging, and some 33 million use a CPAP machine. CPAP devices are highly effective — the problem is a lot of people find the masks uncomfortable.
"CPAP — the constant positive airway pressure — when you use it, it works. It does what it's supposed to do, but the biggest thing is to get people to use this therapy; that is the biggest challenge," says Liran Oren, Ph.D., research associate professor in the Department of Otolaryngology, Head and Neck Surgery at the UC College of Medicine.
Oren and colleagues with UC's engineering department and the UC Sleep Medicine Center are testing a new take on the CPAP machine. It's called a VortexPAP machine. Earlier testing showed the device delivers the same air pressure levels as a traditional CPAP, but the mask is much more comfortable. The difference, Oren says, is the VortexPAP doesn't require a tight seal.
Instead of having a continuous airflow, the VortexPAP pulsates the airflow and each pulse is made out of a vortex, Oren explains. It's similar to when someone blows a smoke ring. The air is forcefully pushed out and you can see the ring float across the room. However, if they just exhale, the smoke stays around the face.
"The aerodynamic of that ring is very different compared to continuous airflow. What we're doing is basically shooting this train of vortices into your nose, instead of having continuous airflow. The aerodynamic is very different; we can actually pressurize the airway in the same manner as CPAP devices, we just don't need the seal anymore."
Since no seal is needed, the mask can be designed differently. The prototype has two hoses like oxygen cannulas. The hoses connect to a box that is similar to a traditional CPAP but which produces the vortical airflow. The device can then be worn using straps like current CPAP masks have, or an adhesive can be used to anchor the tubing to the face and eliminate the need for straps all together.
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After the initial testing, the researchers received funding from the National Institutes of Health to create several prototypes. They're completing the boxes now that generate the airflow and expect that will be finished in about a month.
"At that point, we're going to proceed with doing the real clinical study where people are going to go to sleep with these new mask designs, and the airflow is going to be produced from the box, and we're going to use this data to submit to get approval from the FDA," says Oren.
He anticipates needing about 20 study participants to start with, though more could be added based on FDA feedback. Testing is slated to begin in the summer and run for about a year. You can find the study by searching using the keywords ‘CPAP’ or 'VortexPAP’.
If successful, Oren says, it's unclear how long it could take the VortexPAP to come to market.
The University of Cincinnati is a financial supporter of Cincinnati Public Radio.