Journal of Clinical Sleep Medicine最新文献

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Patterns of heart rate reduction during sleep onset in participants with and without insomnia. 有失眠症和无失眠症参与者睡眠时心率降低的模式。
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-08-01 DOI: 10.5664/jcsm.11714
Yan Ma, Peter M Wayne, Janet M Mullington, Gloria Y Yeh
{"title":"Patterns of heart rate reduction during sleep onset in participants with and without insomnia.","authors":"Yan Ma, Peter M Wayne, Janet M Mullington, Gloria Y Yeh","doi":"10.5664/jcsm.11714","DOIUrl":"10.5664/jcsm.11714","url":null,"abstract":"<p><strong>Study objectives: </strong>Hyperarousal is common in patients with insomnia. Autonomic stress may reflect hyperarousal and distinguish participants with insomnia vs good sleepers. Slope analysis of heart rate reduction during sleep onset might be a promising measure of such autonomic modulation. We aim to explore the potential utility of this measure with data collected from home settings from the Sleep Heart Health Study.</p><p><strong>Methods: </strong>In this secondary analysis with 743 participants, we applied 2 approaches to compute slopes for heart rate reduction during sleep onset. We compared slopes among participants with and without insomnia symptoms, with short vs long sleep onset latency, with or without difficulty falling asleep during the study night, and with sleep-onset insomnia vs other insomnia subtypes. We also explored correlations between heart rate reduction and sleep outcome measures.</p><p><strong>Results: </strong>We found that the slopes of heart rate reduction during sleep onset were most significantly associated with objectively measured sleep onset latency, followed by self-reported sleep onset latency, regardless of the approach used to compute the slopes. Participants with self-reported difficulty falling asleep during the study night had significantly blunted heart rate reduction. The slopes were significantly blunted in participants with self-reported sleep-onset insomnia compared to other types of insomnia.</p><p><strong>Conclusions: </strong>As measures of autonomic activity, the slopes of heart rate reduction may serve as a physiological biomarker to indicate hyperarousal during wakefulness before sleep onset. Tracking changes of heart rate reduction during sleep onset may have potential value in the evaluation of insomnia treatments, especially those targeting sleep onset difficulties.</p><p><strong>Citation: </strong>Ma Y, Wayne PM, Mullington JM, Yeh GY. Patterns of heart rate reduction during sleep onset in participants with and without insomnia. <i>J Clin Sleep Med</i>. 2025;21(8):1395-1405.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1395-1405"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320692/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144059766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Did adaptive servo-ventilation significantly improve sleepiness and quality of life in opioid users in the European READ-ASV registry? 适应性伺服通气是否显著改善欧洲READ-ASV登记中阿片类药物使用者的嗜睡和生活质量?
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-08-01 DOI: 10.5664/jcsm.11838
David Wang, Brendon J Yee, Frances Chung
{"title":"Did adaptive servo-ventilation significantly improve sleepiness and quality of life in opioid users in the European READ-ASV registry?","authors":"David Wang, Brendon J Yee, Frances Chung","doi":"10.5664/jcsm.11838","DOIUrl":"https://doi.org/10.5664/jcsm.11838","url":null,"abstract":"","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144762154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The relationship between sleep and circadian-sleep phase angles based on dim light melatonin onset predicted from light and activity data. 基于光线和活动数据预测的昏暗灯光下褪黑激素发作的睡眠与昼夜睡眠相角的关系。
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-08-01 DOI: 10.5664/jcsm.11650
Daniel J Reis, Joanna B Huang, Nazanin H Bahraini
{"title":"The relationship between sleep and circadian-sleep phase angles based on dim light melatonin onset predicted from light and activity data.","authors":"Daniel J Reis, Joanna B Huang, Nazanin H Bahraini","doi":"10.5664/jcsm.11650","DOIUrl":"10.5664/jcsm.11650","url":null,"abstract":"<p><strong>Study objectives: </strong>The objective of this study was to evaluate the relationships between various sleep outcomes and circadian-sleep phase angles based on dim light melatonin onset predicted only from light and activity data.</p><p><strong>Methods: </strong>Actigraphy and sleep questionnaire data were obtained from 2 independent datasets using the National Sleep Research Resource: the Multi-Ethnic Study of Atherosclerosis Sleep and the Hispanic Community Health Study/Study of Latinos Sueño Ancillary visit. Predicted dim light melatonin onset (pDLMO) was calculated using the extended Kronauer limit-cycle model. Separate phase angles were calculated as the length of time between pDLMO and sleep timing (sleep onset, sleep midpoint, and sleep offset). Relationships between each phase angle and the following sleep outcomes were assessed separately across datasets: total sleep time, total wake time in bed, sleep maintenance efficiency, self-reported sleep quality, and composite sleep health.</p><p><strong>Results: </strong>Total sleep time and composite sleep health were associated with all 3 pDLMO-based phase angles (<i>P</i> < .001 for all). Phase angles for sleep onset and sleep offset were also associated with total wake time in bed (<i>P</i> < .001 for both). Each relationship was characterized by a clear peak associated with a specific phase angle. No relationships were identified between phase angles and sleep maintenance efficiency or self-reported sleep quality.</p><p><strong>Conclusions: </strong>These findings suggest that pDLMO-based phase angles, which can be easily measured in naturalistic settings, can help identify circadian-sleep misalignment in clinical practice. Expanded use of pDLMO may therefore help guide personalized sleep and chronobiological interventions.</p><p><strong>Citation: </strong>Reis DJ, Huang JB, Bahraini NH. The relationship between sleep and circadian-sleep phase angles based on dim light melatonin onset predicted from light and activity data. <i>J Clin Sleep Med</i>. 2025;21(8):1349-1361.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1349-1361"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143711998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perspective: Precision medicine in OSA: the future of a past and present riddle. 视角:OSA中的精准医学:一个过去和现在的谜题的未来。
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-08-01 DOI: 10.5664/jcsm.11746
Gonzalo Labarca
{"title":"Perspective: Precision medicine in OSA: the future of a past and present riddle.","authors":"Gonzalo Labarca","doi":"10.5664/jcsm.11746","DOIUrl":"10.5664/jcsm.11746","url":null,"abstract":"","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1503-1506"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144041287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prodromal features and risk of neurodegenerative disorders diagnosis in outpatients with REM sleep behavior disorder. 快速眼动睡眠行为障碍门诊患者神经退行性疾病的前驱特征及诊断风险
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-07-31 DOI: 10.5664/jcsm.11824
Lana M Chahine, Anne Newman, Richard D Boyce, Maria M Brooks
{"title":"Prodromal features and risk of neurodegenerative disorders diagnosis in outpatients with REM sleep behavior disorder.","authors":"Lana M Chahine, Anne Newman, Richard D Boyce, Maria M Brooks","doi":"10.5664/jcsm.11824","DOIUrl":"https://doi.org/10.5664/jcsm.11824","url":null,"abstract":"<p><strong>Study objectives: </strong>Individuals with isolated REM sleep behavior disorder (iRBD) are at high risk of neurodegenerative parkinsonian disorders or dementia (NPD). Determining which characteristics predict greatest risk could improve clinical care. Our objectives were to utilize electronic health record (EHR) data to apply prodromal PD research diagnostic criteria to iRBD outpatients and determine their utility for identifying iRBD cases at high vs low risk for NPD diagnosis.</p><p><strong>Methods: </strong>This was a retrospective cohort study at a tertiary care center in Western Pennsylvania. Diagnosis of iRBD was confirmed with expert manual chart review. Prodromal risk markers and signs/symptoms were determined with diagnostic codes. Multivariable Cox proportional hazards models examined a range of covariates as predictors of time to NPD diagnosis.</p><p><strong>Results: </strong>Of 448 iRBD cases, 82 (18.30%) were diagnosed with NPD. Forty-nine (10.93%) had >80% prodromal PD probability. There was no difference in time to NPD among those who met vs did not meet >80% probability (log rank p=0.49). In a Cox model that included all assessed criteria features, risk of diagnosis was associated with male sex (HR=2.06, 95%CI 1.04-1.10), older baseline age (HR=1.07; 95%CI 1.05-1.10), and cognitive dysfunction diagnostic code (HR= 2.83, 95%CI 1.79-4.46). Time to NPD diagnosis among predicted high- vs low- risk cases was significantly different (Log-rank test p=0.012).</p><p><strong>Conclusions: </strong>In outpatients with iRBD, a model combining individual PD risk factors and prodromal features accurately identifies individuals at high risk for NPD diagnosis. Results demonstrate the potential of EHR data to translate research on prodromal PD to the clinic.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Artificial intelligence in sleep medicine: an updated American Academy of Sleep Medicine position statement. 睡眠医学中的人工智能:最新的美国睡眠医学学会立场声明。
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-07-31 DOI: 10.5664/jcsm.11832
Margarita Oks, Ramesh Sachdeva, Mattina A Davenport, Aatif M Husain, Maninder Kalra, Vidya Krishnan, Trung Le, Ankit A Parekh, Hyung Park, Bharati Prasad, Scott M Ryals, Subaila Zia, Matthew Anastasi, Anita V Shelgikar, Fariha Abbasi-Feinberg, Alexandre Rocha Abreu, Anuja Bandyopadhyay, Indira Gurubhagavatula, Vishesh K Kapur, David Kuhlmann, Eric J Olson, Susheel P Patil, James A Rowley, Lynn Marie Trotti, Emerson M Wickwire
{"title":"Artificial intelligence in sleep medicine: an updated American Academy of Sleep Medicine position statement.","authors":"Margarita Oks, Ramesh Sachdeva, Mattina A Davenport, Aatif M Husain, Maninder Kalra, Vidya Krishnan, Trung Le, Ankit A Parekh, Hyung Park, Bharati Prasad, Scott M Ryals, Subaila Zia, Matthew Anastasi, Anita V Shelgikar, Fariha Abbasi-Feinberg, Alexandre Rocha Abreu, Anuja Bandyopadhyay, Indira Gurubhagavatula, Vishesh K Kapur, David Kuhlmann, Eric J Olson, Susheel P Patil, James A Rowley, Lynn Marie Trotti, Emerson M Wickwire","doi":"10.5664/jcsm.11832","DOIUrl":"https://doi.org/10.5664/jcsm.11832","url":null,"abstract":"<p><p>The field of artificial intelligence (AI) is rapidly expanding and has the potential to significantly impact the practice of sleep medicine. Sleep practitioners may be able to augment the efficiency and effectiveness of care delivery to patients by incorporating AI into clinical practice. However, AI must be implemented in a responsible manner, with a full appreciation of the technology's current limitations and evolving nature. Specifically, the tenets of data privacy, fairness and transparency, infrastructure and medical-legal issues must be considered. Many of these issues are evolving and will continue to impact AI implementation in new ways. Enhancements in technology will provide new AI options for clinicians and patients. Evolving case law will influence the legal risks that clinicians, hospitals and sleep centers will face. Creation of new policies within the U.S. and internationally will provide frameworks and safeguards for data privacy and AI use. Sleep clinicians and researchers should remain updated and knowledgeable in these areas. As AI continues to develop and advance in the sleep medicine field, it must be a partner to, and not a replacement for, clinician (i.e., human) oversight. It is the position of the AASM that responsible AI integration into sleep medicine has the potential to enhance clinical care and research but requires careful consideration to overcome clinical validation challenges, ensure ongoing accuracy after implementation, and incorporate clinically relevant and user-friendly tools into practice, while also upholding standards of safety, appropriateness, and transparency.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association between obstructive sleep apnea and thoracic aortic diameter: a cross-sectional study in a clinical sample. 阻塞性睡眠呼吸暂停与胸主动脉直径之间的关系:临床样本的横断面研究。
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-07-31 DOI: 10.5664/jcsm.11828
David C Cistulli, Benjamin K Tong, Philip J Currie, Yu Sun Bin, Glenn M Stewart, Paul G Bannon, Martin Ugander, Peter A Cistulli
{"title":"Association between obstructive sleep apnea and thoracic aortic diameter: a cross-sectional study in a clinical sample.","authors":"David C Cistulli, Benjamin K Tong, Philip J Currie, Yu Sun Bin, Glenn M Stewart, Paul G Bannon, Martin Ugander, Peter A Cistulli","doi":"10.5664/jcsm.11828","DOIUrl":"https://doi.org/10.5664/jcsm.11828","url":null,"abstract":"<p><strong>Study objectives: </strong>Previous studies have suggested that obstructive sleep apnea (OSA) may be associated with aortic dilatation. We aimed to further characterize the association between OSA severity with thoracic aortic diameter.</p><p><strong>Methods: </strong>We evaluated 1470 patients attending an Australian clinic during 2014-2023 and who underwent transthoracic echocardiogram followed by polysomnographic study in the following 6 months (43.7% female, median age 65 years, median BMI 29.6kg/m<sup>2</sup>). Aortic root and ascending aortic diameters were compared among patients based on OSA severity, defined by apnea-hypopnea index (AHI).</p><p><strong>Results: </strong>OSA was observed in 90% of patients. Both aortic root and ascending aorta diameters were associated with increasing OSA severity (p<0.01). These associations remained significant when indexed for height, but not body surface area (BSA). Multivariate analysis considering age, weight, hypertension status, atrial fibrillation, and smoking history suggested an independent role of OSA on aortic dimensions in women but not in men. However, a case-control sensitivity analysis did not demonstrate a significant difference in aortic diameter between no/mild OSA compared to moderate/severe OSA.</p><p><strong>Conclusions: </strong>This is the largest study examining the association of OSA and thoracic aortic dimensions in a clinical sample. It found a significant increase in both aortic root and ascending aorta diameters with increasing OSA severity, although this may be explained by shared risk factors such as age, BMI, hypertension, and atrial fibrillation. A minor independent association between aortic dimensions and OSA severity was observed in women but not men. Further research is warranted to explore the relationship between OSA and aortopathy.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality measure for care of patients with narcolepsy: 2025 update after measure maintenance. 发作性睡病患者护理质量指标:2025年指标维持后更新
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-07-31 DOI: 10.5664/jcsm.11834
Robin M Lloyd, T'Auna Crawford, Ryan Donald, Diedra D Gray, William J Healy, Mithri R Junna, Daniel Lewin, Amee Revana, Sharon Schutte-Rodin
{"title":"Quality measure for care of patients with narcolepsy: 2025 update after measure maintenance.","authors":"Robin M Lloyd, T'Auna Crawford, Ryan Donald, Diedra D Gray, William J Healy, Mithri R Junna, Daniel Lewin, Amee Revana, Sharon Schutte-Rodin","doi":"10.5664/jcsm.11834","DOIUrl":"https://doi.org/10.5664/jcsm.11834","url":null,"abstract":"<p><p>Narcolepsy is a chronic sleep disorder that causes overwhelming daytime sleepiness. In an effort to continue addressing gaps and variations in care in this patient population, the American Academy of Sleep Medicine (AASM) Quality Measures Task Force performed quality measure maintenance on the Quality Measures for the Care of Patients with Narcolepsy (originally developed in 2015). The Quality Measures Task Force reviewed the current medical literature, including updated clinical practice guidelines and systematic literature reviews, existing narcolepsy quality measures, and performance data highlighting remaining gaps or variations in care.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of weekend catch-up sleep with the atherosclerotic cardiovascular disease risk score: a hypothesis-generating study from U.S. and Korean National Health and Nutrition Examination Survey. 周末补觉与动脉粥样硬化性心血管疾病风险评分的关系:一项来自美国和韩国国家健康与营养调查的假设生成研究
IF 2.9 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-07-31 DOI: 10.5664/jcsm.11844
Moon-Kyung Shin, Yoonkyung Chang, Tae-Jin Song
{"title":"Association of weekend catch-up sleep with the atherosclerotic cardiovascular disease risk score: a hypothesis-generating study from U.S. and Korean National Health and Nutrition Examination Survey.","authors":"Moon-Kyung Shin, Yoonkyung Chang, Tae-Jin Song","doi":"10.5664/jcsm.11844","DOIUrl":"https://doi.org/10.5664/jcsm.11844","url":null,"abstract":"<p><strong>Study objectives: </strong>A proportion of the populations sleeps longer on the weekends. We investigated a possible association between weekend catch up sleep (WCUS) and a known index of later development of atherosclerotic cardiovascular disease (ASCVD). We tested for an association of WCUS and ASCVD risk scores in 2 existing datasets.</p><p><strong>Methods: </strong>We analyzed national data from the 2019-2021 KNHANES (n = 11,502) and the 2017-2020 NHANES (n = 2,135). WCUS duration from self-reported questionnaires was categorized as ≤0 hours, >0-1 hours, 1-2 hours, and >2 hours. The ASCVD risk score estimating a 10-year risk of ASCVD events was categorized into low (<7.5%), intermediate (7.5%-20%), and high (≥20%) groups.</p><p><strong>Results: </strong>WCUS (>2 hours) was inversely associated with the high ASCVD risk group in the KNHANES (adjusted odds ratio [aOR] = 0.19, 95% confidence interval [CI]: 0.08-0.45), but not in the NHANES. The inverse association of WCUS (>2 hours) with the high ASCVD risk group was shown only in the KNHANES, independent of weekday sleep duration (aOR = 0.20, 95% CI: 0.07-0.51 for <6 hours; aOR = 0.17, 95% CI: 0.07-0.39 for ≥6-8 hours; aOR = 0.13, 95% CI: 0.03-0.63 for ≥8 hours). However, WCUS (>2 hours) showed no significant association with the high ASCVD risk group in weekday sleep duration subgroups.</p><p><strong>Conclusions: </strong>The apparent association between WCUS and ASCVD in an existing dataset underscore the need to investigate WCUS in prospective studies.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144755034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial. 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。
IF 3.5 3区 医学
Journal of Clinical Sleep Medicine Pub Date : 2025-07-24 DOI: 10.5664/jcsm.11822
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":"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":"https://doi.org/10.5664/jcsm.11822","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":3.5,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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