A Novel Design of an Oral Appliance for Monitoring Electromyograms of the Genioglossus Muscle in Obstructive Sleep Apnea Syndrome.

Obstructive sleep apnea (OSA) is a prevalent source of sleep-disordered breathing. OSA is most commonly associated with dysfunctions in the genioglossus (GG) muscle. In this study, we present the first version of a medical device that produces an electromyogram (EMG) of the GG. The prototype is composed of a (custom-made) 3D-printed mouthpiece. Impressions were taken for the lower arch and scanned with a lab scanner to be converted into digital impressions. ExoCad software was used to design the appliance. Fusion 360 software was then used to modify the design and create tubes to house the electrodes in a bilateral configuration to secure excellent and continuous contact with the GG muscle. Silver-silver chloride electrodes were incorporated within the appliance through the created tubes to produce a muscle EMG. In this preliminary prototype, an EMG amplifier was placed outside the mouth, and isolated electric wires were connected to the amplifier input. To test the design, we ran experiments to acquire EMG signals from a group of OSA patients and a control group in wakefulness. The GG EMGs were acquired from the participants for 60 s in a resting state whereby they rested their tongues without performing any movement. Then, the subjects pushed their tongues against the fontal teeth with steady force while keeping the mouth closed (active state). Several features were extracted from the acquired EMGs, and statistical tests were applied to evaluate the significant differences in these features between the two groups. The results showed that the mean power and standard deviation were higher in the control group than in the OSA group (