Severe OSA Study (SOS)

NATerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

September 12, 2022

Primary Completion Date

February 15, 2024

Study Completion Date

February 15, 2024

Conditions
Obstructive Sleep ApneaSleep Apnea
Interventions
DEVICE

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.

Trial Locations (5)

10010

Mount Sinai Integrative Sleep Center, New York

13066

Advanced ENT Physicians and Surgeons of CNY, Fayetteville

55455

University of Minnesota, Minneapolis

94063

Stanford Sleep Medicine Clinic, Redwood City

02115

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
lead

ProSomnus Sleep Technologies

INDUSTRY

NCT05445869 - Severe OSA Study (SOS) | Biotech Hunter | Biotech Hunter