Non-Invasive Oropharynx Appliance to Maintain Airway Patency

Obstructive Sleep Apnea (OSA) is a serious condition that affects about 4% of the population. During sleep, the tongue can fall into the oropharynx and occlude the airways Patients with this condition suffer many instances of apneas (complete cessation of breathing) and hypopneas (period of abnormally low respiratory rate). The apnea- hypopnea index (AHI) gives the number of such episodes per hour and indicates the severity of this condition (AHIandlt;5 is normal while AHIandgt;30 is severe). Abnormal AHIs are associated with significant decrease of oxygen saturation leading to severe co-morbidities such as stroke, high blood pressure, diabetes, epilepsy and cardiac arrhythmia. The cost to the society of OSA-related illnesses ranges between 60 and 160 billion dollars annually. The current standard-of-care is the continuous positive airway pressure (CPAP) device which has a low compliance of around (50%). There are also other therapeutic modalities either invasive or non-invasive but none are very effective. There is at present no non-invasive solution that can ensure both patient compliance and efficacy. A new start-up, ANÉMed proposes to develop and test a novel non-invasive oropharynx appliance (OPA) capable of providing both efficacy and compliance. This new appliance addresses the problem of OSA by placing a tongue retaining device directly into the oropharynx preventing the tongue from obstructing the airways. The new design can prevent obstruction without causing a gag reflex and still allowing swallowing. It is designed to be more effective that other oral appliances such as the mandibular advancement device. If successful, the OPA could become the first line of defense against OSA for over 25 million Americans with a diagnosis of OSA.Narrative: Millions of Americans suffer from obstructive sleep apnea, a condition whereby the tongue obstructs the airway during sleep. Commercially available devices to treat this condition have either low compliance or efficacy. The proposed experiments will test a novel non-invasive oral appliance with significant potential to effectively treat this condition.