Front-loaded to a Fault?

Jan 16, 2019

Excerpt from Sleep Review Magazine, published on January 14, 2019

CleveMed is one such stakeholder. The sleep diagnostics company has recently earned more than 20 patents related to long-term therapy management, mostly related to wireless communication between CPAPs and home devices. Hani Kayyali, CleveMed president and CEO, says, “About 15 years ago, when we started developing the technology and protecting it with our [intellectual property], insurance policies and the industry in general were focused more on the problem and less on the solution! Policies for identifying, diagnosing sleep apnea in the sleep labs, and initiating treatment were established (for the most part), but long-term therapy monitoring received less attention. Given the duration of CPAP therapy, often for decades, and the prevalence of serious cardiovascular comorbidities, we believed that, at least for some patient populations, a deeper review of therapy outcomes beyond the standard CPAP compliance report will become necessary.”

Integrating CPAP, HST, and More

CleveMed’s Kayyali has a dramatic vision for sleep apnea device integration. He thinks a “richer set of physiological parameters are needed” to track patients who are of greatest concern to clinicians, including those who are nonadherent or who have new or worsening comorbidities. One solution, he says, is to integrate home sleep testing (HST) devices with positive airway pressure devices. “One home device described in our [patent] claims is a sleep monitor that can be integrated wirelessly to send its data like respiratory effort, heart rate, blood oxygenation, and body position to the CPAP and merge that data with standard CPAP measurements like airflow and mask leak for a more detailed compliance report,” he says.

While Kayyali concedes that assessing disease severity through CPAP-AHI could be sufficient for compliant patients, he says the additional cardiorespiratory signals that could be provided through an integrated home sleep test can “offer a more detailed picture of patient response and may be more reliable for treatment monitoring and intervention” for those who need it.

Big Data Could Provide Big Solutions

Accessibility issues notwithstanding, companies are eyeing opportunities in big data, which some see as an underutilized information source that could help with long-term patient management.

“Given the growing role of Big Data in influencing care pathways, the demand for more sleep information will only intensify,” says CleveMed’s Kayyali. “By coordinating with healthcare providers, CleveMed intends to apply algorithms to its HST data set, which exceeds over 120,000 studies, to determine interesting correlations with disease outcomes that may assist in directing research efforts for the future.”

Already, CleveMed is seeing real-world applications. Upon request, it gives providers reports of their HST data, highlighting aspects such as study success rate, prevalence of comorbidities, turnaround time, and others. CleveMed medical director Tim Kowalski, MD, CPE, says, “For instance, you can look at the 4,000 studies that a given entity ordered and tell the typical level of severity result. If all the tests come back with severe results, then it’s logical to ask: Are you missing people in the moderate range? Or, if a lot of people are getting results that indicate mild sleep apnea, then the provider could consider if they are over-testing.”

Kowalski, who practiced sleep medicine for 30 years, says anyone who has robust databases can analyze their data to move the field forward. “Academic centers are always looking at data and the next best thing. They can use these databases and make best practice guidelines,” he says. “And businesses, either diagnostic or treatment equipment, can also take the lead.”


Optimizing Long-term Management

As sleep medicine evolves, OSA management strategies will likely evolve as well…