First patient with Obstructive Sleep Apnoea recruited for new clinical trial – July 2016 (Trial now closed)
Sleep disorder device manufacturer and developer Oventus Medical Ltd. (ASX: OVN) is pleased to announce the recruitment of the first patient with obstructive sleep apnoea (OSA) in its latest clinical trial.
The trial is designed to produce data around the comfort, safety and efficacy of the O2VentTM T, 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’s 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 O2VentTM Mono showed the benefit of the inclusion of the airway, especially for OSA patients with nasal obstructions. This trial uses our 2nd generation device, the O2VentTM 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 is being run through Breathing Assist Solutions in Brisbane, Queensland.
The O2VentTM 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.
For more information please contact Breathing Assist Solutions on 1300 416 743.
January 2017 – Please note this clinical trial has now been fully subscribed and is closed.