ProSomnus® Sleep Technologies Commences Landmark Randomized Controlled Study Investigating Real-World Outcomes for Patients with Obstructive Sleep Apnea (OSA)
ProSomnus Sleep Technologies is the Leader in Precision Oral Appliance Therapy for OSA
San Francisco, CA, July 22, 2019 – ProSomnus announces enrollment in the SARAH Study, a landmark investigation of real-world disease alleviation for patients with Obstructive Sleep Apnea (OSA). Presently, OSA therapy selection is predominantly based upon disease alleviation in a controlled test. However, a growing number of studies indicate that disease alleviation in real world, every day, settings is likely different. The SARAH Study, based upon the SARAH Index concept1, is designed to test these differences for two leading OSA therapies, CPAP and Oral Appliances.
“The Effective AHI, (SARAH index) tells the real story of how well an OSA therapy is working in the real world with patients. McEvoy2 demonstrated the impact of adherence on outcomes, we need this research to help us match the best therapy, considering adherence, for our patients,” states Lee A. Surkin, MD. Dr. Surkin is Board Certified in Cardiology and Sleep Medicine and President of Empire Sleep Medicine in NY where SARAH patients are enrolled.
Enrollees diagnosed with OSA and prescribed Oral Appliances will be treated by Dr. Barry Chase, DDS, Chase Dental Sleep Care and Diplomate of the American Board of Dental Sleep Medicine. “The ProSomnus Sleep Devices enable excellent outcomes. Equipping patients with a Fitbit wearable and communicating performance will help facilitate the study endpoints and could serve as a template for future treatment protocols,” notes Dr. Chase.
The goals of the SARAH Study resonate with Dimitry Kargman, CEO of iSLeep Program®, “Treating our patients with the best outcomes and maintaining that success is our top priority.” iSLeep, a comprehensive diagnostic and treatment solution for sleep apnea, is a partner for this study.
“OSA is not a disease that is cured with a single night test,” commented Dave Kuhns, Chief Science Officer for ProSomnus. “ProSomnus devices are designed to make it easy and comfortable for patients with OSA to integrate Oral Appliance device therapy into their everyday lives. We look forward to the results of this important study.”
The SARAH Study is registered under Advarra IRB #Pro00031277.
About ProSomnus Sleep Technologies
ProSomnus® Sleep Technologies designs, manufactures and markets FDA Cleared Class II Medical Devices dentists use to treat patients diagnosed with Obstructive Sleep Apnea. ProSomnus Devices are the first, precision oral appliance therapy devices designed to enhance compliance, mitigate side effects and, enable dentists to achieve excellent patient experiences and outcomes. They have been used to treat thousands of patients, with clinical performance that has been validated in randomize controlled trials, retrospective cohort studies, and numerous clinical case reports.
Heather Whalen, VP, Marketing
1 Sutherland K, Phillips CL, Cistulli PA. Efficacy versus effectiveness in the treatment of obstructive sleep apnea: CPAP and oral appliances. Journal of Dental Sleep Medicine 2015;2(4):175–181.
2 R. Doug McEvoy et. al, “CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea”, NEJM AUG 2016.