The Severe Obstructive Sleep Apnea (SOS) study, a prospective, FDA-reviewed, multi-center, single-arm study evaluating the safety and efficacy of precision oral appliance therapy with the ProSomnus EVO Sleep and Snore device in individuals with severe OSA, has enrolled its first patient.
ProSomnus intends to use data from the SOS study to apply for an expanded indication for use with the FDA, which could make ProSomnus EVO the first oral appliance therapy (OAT) device cleared for treating patients with severe obstructive sleep apnea. To date, oral appliances have only been FDA-cleared for use for mild to moderate obstructive sleep apnea, though some physicians prescribe them off-label to people with severe OSA.
Efficacy and safety are the two primary endpoints. Researchers will assess the ProSomnus EVO’s efficacy by measuring participants’ apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) six months after initiation of oral appliance therapy. Investigators will evaluate the safety of the ProSomnus EVO by reviewing reported adverse events, dental examinations, and safety evaluations.
“Many patients with severe OSA are in dire need of treatment, and previous research suggests that ProSomnus’ precision OAT devices could successfully treat most patients’ OSA,” says John E. Remmers, MD, chief scientist at ProSomnus, in a release. “Further establishing the efficacy and safety of precision OAT in this study could lead to the wider adoption of a much-needed alternative to CPAP, which many patients cannot adhere to because of the discomfort it can cause.”
Customized based on the anatomy and treatment plan for each patient, the ProSomnus EVO precisely repositions and stabilizes the jaw during sleep, improving airflow through a patient’s pharyngeal space. The ProSomnus EVO consists of maxillary and mandibular aligners that are precision-manufactured with twin-mated posts and is digitally manufactured to be patient-specific. Prescribed advancements can be achieved by removing the current upper- or lower-device arch and inserting the next arch in the mandibular advancement series.
Participants in the study will receive a custom ProSomnus EVO and be tested using a type II home sleep apnea test (HSAT) to determine if they have achieved an AHI of less than 15 with the device in place. Researchers will administer HSATs at predetermined intervals. To determine the ProSomnus EVO’s efficacy for severe obstructive sleep apnea, participants will complete a set device advancement and testing protocol and a final HSAT six months after precision OAT begins. During each visit after precision OAT begins, researchers will conduct safety evaluations, along with dental exams and adverse event reports, to determine the ProSomnus EVO’s safety. After collecting data for the study’s primary endpoints for six months after precision OAT begins, researchers will monitor participants for six more months.
“OSA is a health issue of global proportions with dire health and economic consequences if not properly treated. Physicians must be able to provide severe OSA patients with a treatment option that they will use every night, all night,” says Len Liptak, co-founder and CEO of ProSomnus, in a release. “This study is designed to validate the ProSomnus EVO as a safe and efficacious treatment option for the millions of people with OSA, giving healthcare providers a patient-preferred alternative to CPAP and hypoglossal nerve stimulation implants.”