ABSTRACT

Following the studies mentioned previously, which confirmed the success of electrical stimulation methods for opening the airway in OSA patients without arousal from sleep, as well as additional animal studies (12), an FDA-approved feasibility study was undertaken to investigate the treatment of OSA patients with a fully implantable hypoglossal nerve stimulation system. This system, the Inspire I (Medtronic, Inc., Minneapolis, MN), consists of components that were designed to reliably predict the onset of the inspiratory phase of respiration and to stimulate the hypoglossal nerve during inspiration. The system components include an implantable pulse generator (IPG), a respiratory pressure sensor, and a tripolar, half-cuff peripheral nerve stimulation electrode. The IPG contains a programmable microprocessor that allows stimulus frequency, duration, and amplitude to be adjusted

Figure 1 Mean maximal inspiratory airflow (VImax) levels for eight OSA patients before, during, and after neuromuscular stimulation of the genioglossus muscle during sleep. (From Ref. 10.)

Breathing

transcutaneously by a physician programmer. The peripheral nerve lead and the respiratory pressure sensor interface with the IPG (Fig. 3).