It’s estimated that 54 million to 60 million people have sleep apnea in the United States, and 80% of these people are going undiagnosed and untreated. Economically, sleep apnea also costs the U.S approximately $149.6 billion annually. Home sleep apnea testing (HSAT) helps with this burden because it makes testing more accessible to everyone, especially during a pandemic, when visiting a sleep lab might not be a priority or a possibility for people. Itamar Medical, a digital health and device company, has developed a noninvasive method of testing called Peripheral Arterial Tonometry to test patients for sleep apnea in their homes. The technology measures blood volume changes that occur during apnea events—all through the patient’s finger. CEO Gilad Glick sat down with HomeCare to tell us more.
HomeCare: Tell us about Itamar Medical.
Gilad Glick: We are not only extremely passionate about diagnosing sleep apnea but also integrating sleep apnea management into the cardiac patient care pathway as well. We have pioneered and developed a completely new approach to home sleep apnea testing. Our core product is called WatchPAT; it’s a Food and Drug Administration (FDA)-cleared home-based diagnostic device that uses innovative technologies, namely our proprietary PAT (Peripheral Arterial Tonometry) technology, together with an advanced algorithm that analyses seven signals to ensure the accurate detection of sleep apnea. This technology enables non-intrusive and highly accurate sleep testing without the complexity and discomfort of straps, tubes, and the unfamiliar surroundings you have in traditional sleep labs at the comfort of patient’s home.
Another very exciting advancement we have made is our WatchPATOne device. This is the first and only fully disposable HSAT solution—patients receive the device, use it at home and can then discard it immediately after completing the test. The device uses a simple smartphone app to transmit the patient’s sleep data to our cloud platform for analysis, and within just one night—as long as the patient has gotten at least four hours sleep—a diagnosis can be made, all from the comfort of their own bed. We introduced this product to remove the need for patients to return the device for analysis as well as to completely eliminate the risk of exposure to infection—which has proven to be significantly valuable during this pandemic.
HC: Why is home sleep apnea testing important for diagnosing sleep apnea and other disorders?
Glick: Only five years ago, sleep apnea was considered a lifestyle disorder, where people snore excessively and are always tired throughout the day. But it is actually a very serious disorder that people have no control over. Sleep apnea is also a high-risk factor for other serious and life-threatening chronic health conditions. Diabetes, stroke and cardiovascular disease are all comorbidities of sleep apnea; approximately 60% of cardiovascular patients also suffer from sleep apnea. By diagnosing and treating sleep apnea, these disorders can be better managed.
Traditional in-lab sleep testing is considered the gold standard, but these are expensive, intrusive, inconvenient, and not always readily accessible to everyone. Home sleep testing offers a more cost-effective, convenient and nonintrusive solution. Patients can take a comprehensive and equally accurate sleep test from their own beds. This makes it easier to ensure that fewer patients go undiagnosed.
The convenience and comfort associated with at-home sleep testing addresses several concerns that patients could have, for example, patients might be unsettled by the idea of staying in a lab overnight and being monitored, and others might live in remote locations where in-lab testing and facilities can’t be accessed easily, or could have other medical issues that prevent them from leaving their home to spend a night in a lab or simply can’t afford it if they have not yet met their deductibles or even have a high co-pay. HSAT solutions are therefore extremely important to ensure that every patient in need is able to access and complete a sleep test.
There is also research showing that our brains might prevent us from getting a good night’s sleep when we are in unfamiliar surroundings—known as the first-night effect. While the right hemisphere of the brain is asleep, the left remains alert. This is because we are our most vulnerable when we are asleep, and so our brains stay partially awake to protect us and allow us to wake up sooner if there is a threat. In-home testing may therefore provide a more accurate reading because the patient’s brain is completely at rest. There are also cases when allergy to a pet or tree is the root cause of poor breathing during sleep, but is absent during in-lab test.
HC: How does Peripheral Arterial Tonometry work to diagnose sleep apnea?
Glick: The Peripheral Arterial Tone (PAT) signal is a special physiological signal. It mirrors change in the autonomic nervous system that is caused by respiratory disturbances during sleep. PAT measures arterial function and the blood volume changes driven by the autonomic nervous system.
The WatchPAT devices use PAT to measure the flow of blood in the arteries and determines when an apneic event took place. This is measured through the fingertip. When apneas occur, the body initiates a “fight or flight” event in response, the blood vessels contract rapidly in the peripheral organs like the fingers, increasing blood flow significantly to the big muscles and lungs. WatchPAT is able to detect these events through the dramatic reduction of blood volume at the tip of the finger and determine the presence and degree of sleep apnea based using sophisticated algorithms that we have developed.
HC: It’s not just Sars-CoV-2 that people have to worry about. How can home sleep testing keep at-risk patients safe during cold and flu season?
Glick: The most obvious answer is that home sleep testing keeps patients, particularly those at risk, out of sleep labs and the hospital or clinic setting and therefore decreases their exposure to viruses. The increased risk of patients coming into contact with and contracting viruses such as COVID-19 and the flu by other patients are mitigated. In most cases, patients aren’t even required to visit a lab or clinic to pick up a HSAT device and can have them shipped/delivered to their homes. They then ship the device back to their physician for analysis once they’ve taken their test or, if WatchPAT ONE is used, the information is transmitted automatically and immediately This is both more convenient and hygienic that traditional in-lab testing and makes
Also, due to the pandemic, the American Academy of Sleep Medicine has urged all sleep technicians to cease and postpone in-person and in-lab sleep studies and has instead advised that they use at-home diagnostic solutions.
HC: Do you have plans to partner with home medical equipment and home health providers? If so, what would that look like?
Glick: We have already established a number of partnerships with providers and we even have a technological partnership in the space.
One of the great ecosystem partnerships is with BetterNight, a company that has developed a unique process and system to dispatch and fit CPAP devices remotely at patient homes using an artificial intelligence algorithm that allows them to monitor patients for any important variations, and use human care-coordinated calls to guide patient adherence to the therapy. We have integrated our cloud platform with theirs to make the entire process and care pathway seamless for the patient, from diagnosis through to therapy to adherence.
It is of the upmost importance to Itamar Medical to be able to digitally integrate the entire care pathway, so that patients receive a single seamless solution without the need to leave home. We want to ensure that patients can access a single, comprehensive sleep apnea management solution that addresses all their needs to optimize outcomes and partnering with other industry leaders allows us to achieve this.