ProSomnus Sleep Technologies and BlueSleep Announce Enrollment and Preliminary data from the EFFECTS study

April 27, 2017 | Editor

ProSomnus® Sleep Technologies and BlueSleep®

Announce Enrollment and Preliminary data from the EFFECTS study

 

EFFECTS It is the first study to objectively measure oral appliance effectiveness using compliance monitoring chips and consumer Sleep trackers. This study also uses Oral Appliance Therapy (OAT) as the frontline treatment of choice for Obstructive Sleep Apnea. The study utilizes the ProSomnus® MicrO2® Sleep and Snore Device and a telemedicine protocol including patient sleep tracking and compliance to demonstrate the Effectiveness of treatment for patients with mild, moderate and severe Obstructive Sleep Apnea (OSA).

 

NEWS PROVIDED BY       ProSomnus® Sleep Technologies    April 26, 2017

 

Pleasanton, CA, April 26, 2017 – ProSomnus® Sleep Technologies, the leader in precision oral appliance manufacturing for obstructive sleep apnea, has announced the beginning of the EFFECTS study. It is estimated that up to 20% of the population has OSA and only 10-15% have been identified and diagnosed. According to the RAND study, the comorbidities, accidents and other deleterious sequelae to OSA and poor sleep are estimated to cost the US economy upwards of 411 Billion Dollars or 2.28% of the GDP. One problem with treatment is, many patients abandon CPAP, or avoid this alternative completely. Oral appliances are an emerging therapy that offer a better patient experience and therapeutic outcomes. This study is designed to confirm this.

 

Patients with apnea hypopnea index of 5-50 will be treated with the MicrO2. The patient’s compliance will be monitored using the DentiTrac® Compliance Chip (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 new important metric will demonstrate the impact on treatment outcome as it relates to compliance and the critical role oral appliance therapy has on long term treatment. The principal investigator, Dr. Jordan Stern, MD of BlueSleep.

 

Sleep apnea is the disease of the century, and the current medical establishment is not properly addressing this epidemic,” stated Jordan Stern, MD, Founder and CEO of Blue Sleep. “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!

 

“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," commented Len Liptak, CEO of ProSomnus Sleep Technologies. "ProSomnus is honored to partner with Blue Sleep, Dr. Stern and Beddit on this important study."

 

“ProSomnus is committed to evidenced based claims to support our products and the processes enabled by our customers that advance the health of patients,” added David Kuhns, PhD, VP of Technology at ProSomnus. “Through controlled studies like this, ProSomnus supports the evolution of OSA treatment using OAT through excellence in appliance design and treatment protocols”.

 

About ProSomnus Sleep Technologies

ProSomnus® Sleep Technologies designs, manufactures and markets innovative intraoral sleep devices that dentists use to treat patients diagnosed with Obstructive Sleep Apnea. The company’s flagship product is the MicrO2® Sleep and Snore Device. The MicrO2 Sleep Device is a FDA Cleared Class II Medical Device that is smaller, stronger, more biocompatible, and more precise than predicate intraoral sleep apnea devices, allowing dentists to get patients into therapy faster, and with greater comfort and simplicity. The MicrO2 has been used to treat thousands of patients, with clinical performance that has been validated in controlled trials, retrospective cohort studies, and numerous clinical case reports.

 

About Blue Sleep

BlueSleep® is a digital sleep health and wellness company founded by award winning head and neck surgeon and sleep specialist Dr. Jordan Stern. BlueSleep is changing the way sleep apnea is diagnosed and treated by embracing new home sleep testing technologies, sleep trackers and sensors, and favoring oral appliance therapy as first line therapy. The company 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 US, with plans to expand to Europe, Asia and the Middle East.

 

Presentation of preliminary results will be made by Jordan Stern, MD at the AADSM 26th Annual Meeting in Boston, MA on Friday June 2, 2017 at the Industry Supported Event (ISE) sponsored by ProSomnus Sleep Technologies.

 

Media Contact

Heather Whalen, Senior Director of Marketing and Education; (925) 803-8653; hwhalen@prosomnus.com