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.
Once patients have started on CPAP, the CPAP mask blocks the standard connection port for a home sleep test nasal cannula/thermistor, Kayyali says, which translates into a more complex HST setup involving an additional tube. So CleveMed’s solution offers an easier way to implement home sleep testing with CPAP using wireless technologies.
He likens repeat home sleep testing for patient subpopulations to the care protocols recommended for people with diabetes. “While diabetics are asked to measure their blood sugar daily, they are also asked to measure their A1C twice a year per the American Diabetes Association,” Kayyali says. “Therefore, in the case of diabetes, the standard of care includes a more complete picture of sugar level in the body as a whole, in addition to the daily snapshot assessment. Shouldn’t sleep apnea be treated the same way?”
Because other parameters impact comorbidities such as cardiovascular risk, additional sensors, including those from consumer wearables, may one day also be integrated into CPAP-HST data. This could include measurements such as nocturnal blood pressure, weight, and daily steps.
Parallel innovation is happening in the cardiology sphere. For example, some new pacemakers include sleep apnea measurements. An analysis of 54 elderly patients implanted with LivaNova Reply 200 pacemakers found a strong positive correlation between respiratory disturbance index (RDI) as measured by the pacemaker’s transthoracic impedance-derived algorithm and a conventional RDI measurement conducted during an in-lab polysomnogram.4
Access Challenges Continue
Strides are being made, but other obstacles remain firmly in place. One such issue is: Who owns positive airway pressure data? As Patel sees it, “PAP manufacturers believe they own the data and can control/sell the data as they see fit since it lives on their servers, while DME providers believe they own the data as they set up the patients. Patients are increasingly concerned about how either PAP manufacturers or DME providers handle their data including sharing it with third-party payors or others.” Legal changes are likely needed to ensure physicians have ready access to the data, Patel says.
Bob Stanton, a truck driver who works for a company that hires commercial vehicle operators, runs into data access issues regularly. Sometimes a truck driver must switch CPAP devices mid-therapy only because he needs a compliance report printout and has no other way to get it.
“A huge issue is for treatment providers getting access to the manufacturers’ software for CPAPs they don’t sell,” says Stanton, who has OSA himself. New drivers “often were tested and put on CPAP while working for another motor carrier using a competitor in OSA testing and treatment.” If the new provider doesn’t sell that specific brand of CPAP, Stanton says the CPAP maker often won’t release the required software log-in rights to access compliance data. Meanwhile the “competitor who sold the machine is no longer getting paid for services by the carrier so they don’t want to run compliance reports,” he says. So “in a couple of cases we ended up just eating the cost of a new CPAP to get access to compliance data,” Stanton says.
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. Also likening sleep apnea care to diabetes care, CleveMed’s Kowalski says, “You wouldn’t take one of the first insulins given to you 20 years ago and take it today. So as science evolves, the treatment needs to evolve. As people evolve, the treatment also needs to evolve.”
Market factors may also sway providers toward long-term management. “The increased emphasis on value-based reimbursement models may lead to physician reimbursements tied to reduction in cardiovascular disease incidence or a valid surrogate such as PAP adherence,” Patel says, adding that changes like this “will increase interest in understanding how to better optimize long-term care of OSA patients on PAP therapy.”
Sree Roy is editor of Sleep Review.
1. Patil SP, Ayappa IA, Caples SM, et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. JCSM. 2019;15(2):in press.
2. Chang J,Liang J, Becker K, et al. 1048 Impact of automated CPAP tele-monitoring on CPAP adherence at 2 years: Follow-up from the Tele-OSA randomized clinical trial. Sleep. 27 April 2018;41(suppl_1):A390.
3. Benjafield A, Cooper L, Willes L, et al. 0528 Impact of a mask resupply program on therapy compliance: a retrospective analysis. Sleep. 27 April 2018;41(suppl_1):A197–8.
4. Dias M, Gonçalves I, Amann B, et al. Utility of new-generation pacemakers in sleep apnea screening. Sleep Med. 2017 Sep;37:27-31.