ProSomnus Sleep Technologies, a precision oral appliance for obstructive sleep apnea manufacturer, has announced the beginning of the EFFECTS study.
In the study, patients with an apnea hypopnea index (AHI) of 5 to 50 will be treated with the MicrO2 oral appliance. The patient’s compliance will be monitored using the DentiTrac Compliance Chip (by Braebon Medical Corporation) and total sleep time will be tracked with the Beddit Sleep Tracker. This will create data for the SARAH Index (Sleep Adjusted Residual Apnea Hypopnea Index) to be calculated as a measure of effectiveness. This metric will demonstrate the impact on treatment outcome as it relates to compliance and the role oral appliance therapy has on long-term treatment.
“Sleep apnea is the disease of the century, and the current medical establishment is not properly addressing this epidemic,” says principal investigator Jordan Stern, MD, founder and CEO of a digital sleep health and wellness company BlueSleep, in a release. “Fitness trackers and sleep sensors are raising awareness about sleep health and I am pleased to be using these new technologies along with the ProSomnus MicrO2 Device to bring sleep health to the digital age. Easier diagnosis and better treatment options with the ProSomnus oral appliances will help improve the lives of the tens of millions of Americans suffering from sleep apnea and associated chronic diseases—it’s about time!” BlueSleep has launched a telemedicine service for diagnosis and treatment of sleep apnea through video conferencing available on mobile phones and home computers. The service is now available in much of the United States, with plans to expand to Europe, Asia, and the Middle East.
Len Liptak, CEO of ProSomnus Sleep Technologies, says, “Telemedicine, next generation oral appliances, and consumer electronics have the potential to expand access to effective, comfortable, and efficient obstructive sleep apnea therapy. The aim of the EFFECTS study is to scientifically validate this premise. ProSomnus is honored to partner with Blue Sleep, Dr Stern, and Beddit on this important study.”
David Kuhns, PhD, VP of technology at ProSomnus, says, “ProSomnus is committed to evidenced-based claims to support our products and the processes enabled by our customers that advance the health of patients. Through controlled studies like this, ProSomnus supports the evolution of OSA treatment using OAT through excellence in appliance design and treatment protocols.”
Presentation of preliminary results will be made by Jordan Stern, MD, at the AADSM 26th Annual Meeting in Boston on June 2, 2017 at the industry supported event sponsored by ProSomnus Sleep Technologies.