In patients with obstructive sleep apnea (OSA), the respiratory muscles are not able to maintain an open airway while relaxed during sleep. OSA is associated with a variety of health consequences and, in particular, confers a 4.2 times greater risk of mortality, even after controlling for leading risk factors, including age, sex, weight, and smoking status). A report was published recently that summarized several population-based epidemiological studies of OSA that were published from 1993 to 2013 with samples from Asia, Europe, and America. Prevalence estimates increased over time, which could be due to evolving definitions of OSA, variation in equipment, and other factors. OSA is more common among men and increases with obesity as well as with age independent of other factors.

Technology Description: A hypoglossal nerve stimulation (HGNS) system consists of 3 implanted components: a small implanted pulse generator (IPG), a respiratory-sensing lead, and a stimulating lead surgically placed on the hypoglossal nerve. The IPG is subcutaneously implanted beneath the clavicle in the upper chest and delivers HGNS via the stimulating lead. The sensing lead is placed in the intercostal space and contains a piezoelectric differential pressure sensor for detecting respiratory signals. The IPG synchronizes stimulation of the hypoglossal nerve with the patient’s breathing cycle using input from the sensing lead. The device may be activated 4 to 6 weeks after surgical implantation and the stimulation is titrated to yield ideal outcomes coupled with minimal side effects for each patient. The patient uses a remote control to turn the device on before going to sleep and turn it off upon awakening.

Controversy: HGNS may provide a treatment option for patients with moderate-to-severe OSA for whom continuous positive airway pressure has failed to provide relief, but the procedure may carry risks for complications and postimplantation surgical procedures.

Key Questions:

  • Does HGNS therapy reduce OSA severity, improve quality of life, and/or improve sleep parameters?
  • Is HGNS therapy safe?
  • Have definitive patient selection criteria been established for the use of HGNS therapy?


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