Upper airway stimulation, specifically hypoglossal (CN XII) nerve stimulation, is a new, alternative therapy for patients with obstructive sleep apnea hypopnea syndrome who cannot tolerate positive airway pressure, the first-line therapy for symptomatic patients. Stimulation therapy addresses the cause of inadequate upper airway muscle activation for nasopharyngeal and oropharyngeal airway collapse during sleep. The purpose of this report is to outline the development of this first-in-class therapy and its clinical implementation. Another practical theme is assessment of the features for considering a surgically implanted device and the insight as to how both clinical and endoscopic criteria increase the likelihood of safe and durable outcomes for an implant and how to more generally plan for management of CPAP-intolerant patients. A third theme is the team building required among sleep medicine and surgical specialties in the provision of individualized neurostimulation therapy.
Based on a prior anesthetized model, we developed an unanesthetized model to evaluate the effects of hypoglossal nerve stimulation (HNS) during sleep. We prepared three rabbits with injections of Hyaluronic Acid in the base of tongue to produce upper airway obstruction followed by HNS implant. Two rabbits were saline controls, and one, a passive control. Measures were sleep, airflow, effort, oxygen saturation and heart rate. HNS with electrodes around the right hypoglossal nerve were adjusted to a level without behaviorally disturbing the animal. During HNS stimulation in the tongue-base injected rabbits, obstructive apneas and hypopneas of intermediate (3 to 7 cycles of respiratory effort) or longer (≥8 cycles) duration were largely eliminated while less clinically relevant shorter events (<3) were unaffected, and oxygen saturation was improved. Control animals exhibited no intermediate or long events. In this model HNS can relieve induced sleep apnea, without disturbing the animal: however, despite being non-canine and of substantial size, the model has its challenges.
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