B Tucker Woodson, David T Kent, Colin Huntley, Melyssa K Hancock, Douglas J Van Daele, Maurits S Boon, Tod C Huntley, Sam Mickelson, M Boyd Gillespie, Maria V Suurna, Ashutosh Kacker, Asim Roy, Stuart MacKay, Kirk P Withrow, Raj C Dedhia, Phillip Huyett, Clemens Heiser, Sylvie di Nicola, Fatima Makori, Olivier M Vanderveken, Tapan A Padyha, Ulysses J Magalang, Eugene Chio, Eric J Kezirian, Richard Lewis
{"title":"双侧舌下神经刺激治疗阻塞性睡眠呼吸暂停：一项非随机临床试验。","authors":"B Tucker Woodson, David T Kent, Colin Huntley, Melyssa K Hancock, Douglas J Van Daele, Maurits S Boon, Tod C Huntley, Sam Mickelson, M Boyd Gillespie, Maria V Suurna, Ashutosh Kacker, Asim Roy, Stuart MacKay, Kirk P Withrow, Raj C Dedhia, Phillip Huyett, Clemens Heiser, Sylvie di Nicola, Fatima Makori, Olivier M Vanderveken, Tapan A Padyha, Ulysses J Magalang, Eugene Chio, Eric J Kezirian, Richard Lewis","doi":"10.5664/jcsm.11822","DOIUrl":null,"url":null,"abstract":"<p><strong>Study objectives: </strong>To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNS<sub>BL</sub>) device for the treatment of OSA.</p><p><strong>Methods: </strong>Adult patients with moderate-to-severe OSA who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNS<sub>BL</sub>. The co-primary 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 (ODI). Objective secondary endpoints included changes in mean AHI, ODI, and sleep time with blood oxygen saturation less than 90% (T90). Subjective secondary endpoints included changes in Epworth sleepiness score (ESS), the short Functional Outcomes of Sleep Questionnaire (FOSQ-10) score, the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score, and bedpartner assessment of snoring.</p><p><strong>Results: </strong>HNS<sub>BL</sub> was implanted in 113 participants. Eleven SAEs occurred in 10 (8.7%) participants. The co-primary endpoints were completed by 89 (77.4%) participants. AHI and ODI responses were achieved in 63.5% (73/115, p = 0.002) and 71.3% (82/115, p< 0.001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3±11.8 events/h, p<0.001), ODI (-17.7±14.6 events/h, p<0.001), and T90 (6.9±10.7%, p<0.001). Significant changes were observed in all secondary endpoints (p<0.001).</p><p><strong>Conclusions: </strong>This pivotal clinical trial of HNS<sub>BL</sub> demonstrated an acceptable safety profile with clinically significant improvements in OSA severity and quality-of-life metrics. HNS<sub>BL</sub> is a promising new treatment option for select patients with OSA.</p><p><strong>Clinical trial registration: </strong>Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); Identifier: NCT03868618; URL: https://clinicaltrials.gov/study/NCT03868618.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial.\",\"authors\":\"B Tucker Woodson, David T Kent, Colin Huntley, Melyssa K Hancock, Douglas J Van Daele, Maurits S Boon, Tod C Huntley, Sam Mickelson, M Boyd Gillespie, Maria V Suurna, Ashutosh Kacker, Asim Roy, Stuart MacKay, Kirk P Withrow, Raj C Dedhia, Phillip Huyett, Clemens Heiser, Sylvie di Nicola, Fatima Makori, Olivier M Vanderveken, Tapan A Padyha, Ulysses J Magalang, Eugene Chio, Eric J Kezirian, Richard Lewis\",\"doi\":\"10.5664/jcsm.11822\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Study objectives: </strong>To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNS<sub>BL</sub>) device for the treatment of OSA.</p><p><strong>Methods: </strong>Adult patients with moderate-to-severe OSA who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNS<sub>BL</sub>. The co-primary 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 (ODI). Objective secondary endpoints included changes in mean AHI, ODI, and sleep time with blood oxygen saturation less than 90% (T90). Subjective secondary endpoints included changes in Epworth sleepiness score (ESS), the short Functional Outcomes of Sleep Questionnaire (FOSQ-10) score, the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score, and bedpartner assessment of snoring.</p><p><strong>Results: </strong>HNS<sub>BL</sub> was implanted in 113 participants. Eleven SAEs occurred in 10 (8.7%) participants. The co-primary endpoints were completed by 89 (77.4%) participants. AHI and ODI responses were achieved in 63.5% (73/115, p = 0.002) and 71.3% (82/115, p< 0.001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3±11.8 events/h, p<0.001), ODI (-17.7±14.6 events/h, p<0.001), and T90 (6.9±10.7%, p<0.001). Significant changes were observed in all secondary endpoints (p<0.001).</p><p><strong>Conclusions: </strong>This pivotal clinical trial of HNS<sub>BL</sub> demonstrated an acceptable safety profile with clinically significant improvements in OSA severity and quality-of-life metrics. HNS<sub>BL</sub> is a promising new treatment option for select patients with OSA.</p><p><strong>Clinical trial registration: </strong>Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); Identifier: NCT03868618; URL: https://clinicaltrials.gov/study/NCT03868618.</p>\",\"PeriodicalId\":50233,\"journal\":{\"name\":\"Journal of Clinical Sleep Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-07-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Sleep Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.5664/jcsm.11822\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Sleep Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5664/jcsm.11822","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial.
Study objectives: To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNSBL) device for the treatment of OSA.
Methods: Adult patients with moderate-to-severe OSA who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNSBL. The co-primary 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 (ODI). Objective secondary endpoints included changes in mean AHI, ODI, and sleep time with blood oxygen saturation less than 90% (T90). Subjective secondary endpoints included changes in Epworth sleepiness score (ESS), the short Functional Outcomes of Sleep Questionnaire (FOSQ-10) score, the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score, and bedpartner assessment of snoring.
Results: HNSBL was implanted in 113 participants. Eleven SAEs occurred in 10 (8.7%) participants. The co-primary endpoints were completed by 89 (77.4%) participants. AHI and ODI responses were achieved in 63.5% (73/115, p = 0.002) and 71.3% (82/115, p< 0.001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3±11.8 events/h, p<0.001), ODI (-17.7±14.6 events/h, p<0.001), and T90 (6.9±10.7%, p<0.001). Significant changes were observed in all secondary endpoints (p<0.001).
Conclusions: This pivotal clinical trial of HNSBL demonstrated an acceptable safety profile with clinically significant improvements in OSA severity and quality-of-life metrics. HNSBL is a promising new treatment option for select patients with OSA.
Clinical trial registration: Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); Identifier: NCT03868618; URL: https://clinicaltrials.gov/study/NCT03868618.
期刊介绍：
Journal of Clinical Sleep Medicine focuses on clinical sleep medicine. Its emphasis is publication of papers with direct applicability and/or relevance to the clinical practice of sleep medicine. This includes clinical trials, clinical reviews, clinical commentary and debate, medical economic/practice perspectives, case series and novel/interesting case reports. In addition, the journal will publish proceedings from conferences, workshops and symposia sponsored by the American Academy of Sleep Medicine or other organizations related to improving the practice of sleep medicine.
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