WVU researchers developing home sleep apnea test device to offer help to more patients

MORGANTOWN – WVU medical researchers are developing a home sleep apnea testing device that could open doors for more to get tested – benefiting them as patients, along with the healthcare community and the public in general.

The device pairs a fingertip clip that resembles a pulse oximeter and a slim, flexible black plastic wristwatch connected by a short cable. (Because it’s patented and still in development, and the market is competitive, photos of it were not permitted.)

Dr. Sunil Sharma

“It’s a very ordinary looking device, because we didn’t want to make it too intimidating for the patient,” said Dr. Sunil Sharma, division chief of the Pulmonary, Critical Care and Sleep Medicine Fellowship Program in the WVU School of Medicine, who led the team to develop it.

It’s estimated, he said, that 80% of apnea cases go undetected and unresolved. It’s more magnified in West Virginia, which ranks low on heath metrics across the board, and where geography and other factors hinder access to care.

Not to mention sleep testing in sleep labs is expensive, he said. “Anytime these factors conspire against the patient, the disease is missed.”

In ostructive sleep apnea, the airways partially or completely collapse resulting in a decrease in oxygen saturation. Symptoms include loud snoring and excessive daytime sleepiness, but many people are asymptomatic.

And sleep apnea and lack of sleep can worsen comorbid conditions – heart disease, stroke, afib, diabetes. So apnea going undiagnosed or untreated for too long does more harm.

There are other approved home sleep study devices. A quick internet search showed them – some have similar finger clip-watch components, but more wires and connections. Others add belts and nasal cannulas.

The failure rate for those is high, Sharma said, because the patient can’t sustain all the data channels with all the cable connections throughout the night. This one is simpler and more comfortable.

Researchers often overlook the reason for the study: bad sleep, he said. Sleep labs are too few and the demand too high, leading to long waits. And many patients don’t enjoy being covered with wire leads – like a Star Trek Borg drone – and sleeping away from home in an uncomfortable setting.

And with other home devices, patients will thrash in bed. “They can’t sleep in consistent fashion. It’s even harder to keep all of these devices on your body than a person who quietly sleeps.”

So in researching this device, they thought they could improve the calibration signal to get all the data from multiple channels and consolidate it.

The technology – the device and software – emerged from a five-year study Sharma and colleagues conducted at J.W. Ruby Memorial Hospital. Certain patients were tested for sleep apnea and those who were diagnosed received PAP — positive airway pressure — therapy.

Patients who didn’t adhere to the PAP therapy had significantly higher hospital readmissions and emergency room visits for cardiovascular and pulmonary treatment than those who did.

The study was published in April in the Journal of Clinical Sleep Medicine. Reduced readmissions save costs for the patients, the hosptial, the insurance payers. “I think if we’re saving costs and we are making sure patients are not getting readmitted to the hospital, everybody wins,” Sharma said.

The wristwatch, Sharma said, functions as a black box, collecting the data gathered from the fingertip clip. The patient can’t see the data, which prevents them from curiously monitoring it during the night and disrupting their sleep.

But they are working on a new software program that will offer the patient concise, patient-friendly information, letting them know if they need a physician follow up, instead of having to wait days or weeks for results. Sharma called it “patient empowerment.”

Another advantage of this home device is it’s designed to be used for several nights. This provides more accurate data than a snapshot from a single night, he said.

“I think it’s a first step,” he said. It’s good for patients – and for researchers. Researchers are hamstrung by the costs of the devices and studies, so no large studies are available of how the community at large is affected by sleep apnea.

With this device, they may be able to expand studies from 50 or 60 patients to thousands, and see community-wide impacts.

Sharma said they don’t envision this device replacing sleep labs. There will always be a need for that level of data for some patients.

“Our technology is not designed to compete with the sleep labs,” he said. “Our technology is, there’s so much disease out there that you can’t even handle [in the labs]. It is not even being detected. If it’s not being detected, then you can’t pursue it.”

So they are filling a void, he said.

Sharma has received a National Science Foundation Innovation Corps grant to continue the research. The grant will provide for collaboration among experts from WVU and other institutions. But they are also looking for other investors interested in advancing the work.

He summed up the project this way: “The community has a large burden of this disease that is undetected.” You sleep one-third of your life, and that affects the other two-thirds. “If we fix that one-third, you’ll have a better two-thirds of your daily living.”

Email:[email protected]