Enrollment Begins in Real-world Study Comparing Oral Appliances and CPAP
Enrollment has begun in the SARAH Study, an investigation of real-world disease alleviation for patients with obstructive sleep apnea (OSA). The study is based upon the “SARAH” Index, a sleep adjusted residual apnea-hypopnea index that provides a formula to measure treatment effectiveness taking into account not only efficacy under ideal circumstances but also compliance in real-world circumstances.
This SARAH Study is designed to test these differences for 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. McEvoy demonstrated the impact of adherence on outcomes; we need this research to help us match the best therapy, considering adherence, for our patients,” says board certified sleep physician and cardiologist Lee A. Surkin, MD, in a release. Surkin is president of Empire Sleep Medicine in New York, where patients in this study are being enrolled.
“OSA is not a disease that is cured with a single night test,” says Dave Kuhns, chief science officer for ProSomnus, whose oral appliances will be used in the study. “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.”
Enrollees diagnosed with OSA and prescribed oral appliances will be treated by Barry Chase, DDS, DABDSM, of Chase Dental Sleep Care. He says, “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.”
The goals of the SARAH Study resonate with Dimitry Kargman, CEO of diagnostic-treatment company iSLeep Program, which is also a partner for this study. He says, “Treating our patients with the best outcomes and maintaining that success is our top priority.”
The SARAH Study is registered under Advarra IRB #Pro00031277.
from Sleep Review http://www.sleepreviewmag.com/2019/07/enrollment-real-world-study-oral-appliances-cpap/