Sleep disorder device manufacturer and developer Oventus Medical Ltd has recruited the first patient with obstructive sleep apnea (OSA) for a clinical trial to assess the comfort, safety, and efficacy of its O2Vent T device, as well as the comfort and efficacy of the inclusion of an airway into an oral appliance.
The airway is designed to deliver air to the back of the mouth, bypassing obstructions from the nose, soft palate and tongue. The airway makes Oventus’ devices unique from other mandibular advancement products on the market.
Oventus founder and Clinical Director Dr Chris Hart said: “Our first clinical trial using the O2Vent Mono showed the benefit of the inclusion of the airway, especially for OSA patients with nasal obstructions. This trial uses our second generation device, the O2Vent T, which allows the patient to adjust their lower jaw position under dentist supervision.
“The trial will provide more qualitative and quantitative data on the benefits of the inclusion of the airway for people with and without nasal obstructions. This trial is the first of numerous clinical trials planned over the coming year. The additional clinical evidence will help us to implement our world-wide market rollout plans,” Dr Hart said.
The trial will involve 40 patients and be carried out in Brisbane, Queensland.
The O2Vent T is registered with the Australian Therapeutic Goods Administration while a 510k application for the device has been lodged with the US Food and Drug Administration.