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ABSTRACT: Study objectives
To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNSBL) device for the treatment of obstructive sleep apnea.Methods
Adult patients with moderate-to-severe obstructive sleep apnea who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNSBL. The coprimary endpoints at 12 months were (1) a minimum of 50% reduction in the 4% apnea-hypopnea index (AHI) from baseline with a final AHI of less than 20 events/h, and (2) a minimum of 25% reduction in the 4% oxygen desaturation index. Objective secondary endpoints included changes in mean AHI, oxygen desaturation index, and sleep time with blood oxygen saturation less than 90%. Self-reported secon
SUBMITTER: Woodson BT
PROVIDER: S-EPMC12582211 | biostudies-literature | 2025 Nov
REPOSITORIES: biostudies-literature