A clinical trial demonstrating the efficacy of the ExVent accessory with the O2Vent Optima oral appliance for the treatment of obstructive sleep apnea (OSA) was awarded the Top Abstract Poster Award on behalf of the CHEST 2023 Scientific Presentations and Award Committee.
Awards were granted to five presenters from all of the abstract poster sessions at the CHEST Annual Meeting for outstanding original scientific research and presentation.
The study, authored by Sat Sharma, Antonella Conflitti, and H. Reiter, investigated the efficacy of the O2Vent Optima in 14 patients with mild to moderate sleep apnea for six weeks and followed with six weeks of treatment using the O2Vent Optima with ExVent for six weeks.
The ExVent is an optional accessory to the O2Vent Optima mandibular advancement device and provides oral expiratory positive airway pressure (EPAP). Oral EPAP with the ExVent is designed to provide upper airway support via similar mechanisms of action of nasal EPAP devices in commercial distribution, eg, passive dilatation of the airway, which reduces flow limitation.
Nasal EPAP devices are in commercial distribution as standalone therapies for the treatment of OSA. The oral EPAP provided by the ExVent accessory is designed to augment the OSA therapy provided by the O2Vent Optima.
Investigators found that treatment with Optima and Optima plus ExVent reduced AHI from 22.5±6.4/hr to 12.6±4.5/hr to 5.9±2.7/hr (p< 0.005 baseline vs. Optima and Optima plus ExVent; p<0.05 Optima vs. Optima plus ExVent).
The average reduction in AHI with Optima was 43% and with Optima plus ExVent was 72%. The lowest oxygen during sleep increased from 84.6±2.7% to 88.6±2.9% to 91.6±3.2% (p< 0.005 baseline vs. Optima and Optima plus ExVent; p<0.05 Optima vs. Optima plus ExVent).
Patients on treatment with Optima and Optima plus ExVent demonstrated no excessive adverse events or device malfunction.
Researchers concluded that both Optima and Optima with ExVent significantly improved OSA, while a greater benefit was observed with the addition of ExVent to the Optima in mild to moderate OSA.
ExVent is undergoing review at the US Food and Drug Administration and is not yet for sale in the United States.