Efficacy and Safety
Vaibhav H. Ramprasad, Ryan J. Soose
Abstract
Electrical stimulation of the hypoglossal nerve through implantable neuromodulation systems (UAS) has been demonstrated to be both safe and effective in the management of obstructive sleep apnea (OSA) in a subset of patients meeting specific clinical criteria. After decades of animal and human basic science research confirmed the feasibility and safety of UAS, multiple prospective studies, including the phase III multicenter Stimulation Therapy for Apnea Reduction (STAR) trial, demonstrated the efficacy of UAS in improving both polysomnographic (apnea–hypopnea index, oxygen desaturation index) and patient-reported (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Snoring Visual Analog Scale) outcome measures. Even with the widespread dissemination into routine clinical practice and commercial availability of the therapy across the United States and Europe, these studies also consistently report very low procedure-related or therapy-related serious adverse event rates. Recent comparison studies with upper airway reconstructive surgical procedures suggest that UAS provides treatment that is at least as effective but with reduced postoperative pain and risk, and with preservation of the upper airway anatomy.