35
Participants
Start Date
September 12, 2022
Primary Completion Date
February 15, 2024
Study Completion Date
February 15, 2024
ProSomnus® EVO Sleep and Snore Device
The ProSomnus® EVO Sleep and Snore Device is an intraoral device for snoring and obstructive sleep apnea. It works by repositioning the mandible during sleep, thereby improving the flow of air through the patient's pharyngeal space. The ProSomnus® EVO Sleep consists of maxillary and mandibular device arches that are CAD/CAM designed with twin-mated posts and digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.
Mount Sinai Integrative Sleep Center, New York
Advanced ENT Physicians and Surgeons of CNY, Fayetteville
University of Minnesota, Minneapolis
Stanford Sleep Medicine Clinic, Redwood City
Brigham and Women's Hospital, Boston
Lead Sponsor
ProSomnus Sleep Technologies
INDUSTRY