A Novel Device to Facilitate CPAP Obstructive Sleep Apnea Treatment by Brent H. & Ethan L.

This project will evaluate the efficacy and tolerability of a new, simple CPAP device in treating obstructive sleep apnea.  CPAP, or continuous positive airway pressure, is used to treat obstructive sleep apnea (OSA) by holding the patient’s airway open with pressurized air. The pressure of the CPAP device keeps the airway from collapsing or experiencing a blockage, allowing the patient to get high-quality sleep. Unfortunately, due to the nature of the mask used to administer the treatment, air leakage is possible. This causes pressure to be lost, drastically reducing the effectiveness of the treatment. There are several mask modifications to alleviate the problem, but they all come with drawbacks such as discomfort or an inability to fit. Our CPAP device will attempt to solve these problems. It consists of a piece of silicone gel surrounded by a biocompatible adhesive. Two slanted flaps cut in the center of the gel act as a valve that opens during inhalation and closes during exhalation to maintain air pressure. This device poses several advantages. It is non-toxic, inexpensive, conforms to most facial features, and can easily be applied.

The clinical test subjects will consist of volunteers with a history of OSA who have given their informed consent and undergone basic health screening. Each subject may proceed to the overnight and/or extended treatment evaluation. The overnight evaluation will collect data from a subject’s single session with the device, while the extended overnight evaluation will collect data from a subject over a period lasting up to one year....