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Published on: December 6, 2016
Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial
B Tucker Woodson1, David T Kent2, Colin Huntley3
1Medical College Wisconsin, Milwaukee, Wisconsin.
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 secondary endpoints included changes in Epworth Sleepiness Scale, the short Functional Outcomes of Sleep Questionnaire score, the Symptoms of Nocturnal Obstruction and Related Events score, and bedpartner assessment of snoring.
Results:
HNSBL was implanted in 113 participants. Eleven serious adverse events occurred in 10 (8.7%) participants. The coprimary endpoints were completed by 89 (77.4%) participants. AHI and oxygen desaturation index responses were achieved in 63.5% (73/115, P = .002) and 71.3% (82/115, P < .001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3 ± 11.8 events/h, P < .001), oxygen desaturation index (-17.7 ± 14.6 events/h, P < .001), and sleep time with blood oxygen saturation less than 90% (6.9 ± 10.7%, P < .001). Significant changes were observed in all secondary endpoints (P < .001).
Conclusions:
This pivotal clinical trial of HNSBL demonstrated an acceptable safety profile with clinically significant improvements in obstructive sleep apnea severity and quality-of-life metrics. HNSBL is a promising new treatment option for select patients with obstructive sleep apnea.
Clinical Trial Registration:
Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); URL: https://clinicaltrials.gov/study/NCT03868618; Identifier: NCT03868618.
Citation:
Woodson BT, Kent DT, Huntley C, et al. Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial. J Clin Sleep Med. 2025;21(11):1883-1891.
