Advanced Brain Monitoring has launched Apnea Guard, the first validated temporary oral appliance with clinical equivalence to custom oral appliances for the treatment of snoring and sleep apnea.
The Food and Drug Administration (FDA) approved Apnea Guard has to be worn for up to 30 nights to treat sleep apnea.
Principal investigator Dan Levendowski said Apnea Guard addresses the need identified during a $1m National Institute of Dental and Craniofacial Research study designed to improve clinical outcomes with oral appliance therapy.
"The scientific evidence strongly supports the use of mandibular advancement for the treatment of sleep apnea," Levendowski added.
American Academy of Sleep Medicine chief medical officer Philip Westbrook said Apnea Guard was cleared by the FDA so that hospital staff could use it to assist with the management of hypoxemia and sleep apnea post-operatively.
"For patients suspected of having sleep apnea, it provides a therapeutic safety-net during their hospital stay and after discharge while on narcotic pain medications. The 30-night 'window for use' provides sufficient time for the patient to return for a post-surgery sleep study," Westbrook added.
University Hospital of Ghent researcher and European Society of Dental Sleep Medicine past-president Miche DeMeyer said because Apnea Guard has no metal components and controls both vertical and protrusive adjustment, it can be used in MRI imaging studies to better understand the response of the airway to mandibular repositioning.
The company said Apnea Guard will be introduced at the American Academy of Sleep Medicine and the American Academy of Dental Sleep Medicine conferences from 6 until 13 June 2012 in Boston, US.
Advanced Brain Monitoring is focused on developing innovative solutions for the diagnosis and treatment of sleep, neurological and psychiatric disorders.