The FDA-reviewed, single-arm, multi-centre, prospective study has been designed to assess the efficacy and safety of precision oral appliance therapy (OAT) with the Sleep and Snore device in severe obstructive sleep apnea (OSA) patients.
The study’s two primary endpoints are safety and efficacy.
In the study, researchers will evaluate the efficacy of ProSomnus EVO by measuring the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) of the participants six months after initiating precision OAT.
ProSomnus EVO’s safety will be assessed by reviewing all the reported adverse events, safety evaluations, and dental checks.
ProSomnus chief scientist John Remmers said: “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.
“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.”
The company stated that ProSomnus EVO is an alternative to legacy dental products as well as CPAP machines.
It can be completely customised based on the patient’s anatomy and treatment plan.
The device precisely repositions and stabilises the jaw during sleep that helps in improving the airflow through a pharyngeal space of the patient.
It comprises maxillary and mandibular aligners which are precision-manufactured with twin-mated posts.
The company is planning to use the data from the SOS study to seek an extended indication for use with the US Food and Drug Administration (FDA).
If the trial is successful, ProSomnus EVO will become the first intraoral medical device approved to treat severe OSA patients.