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Classification of cyclic alternating patterns of sleep using EEG signals 利用脑电信号对周期性交替睡眠模式进行分类
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-24 DOI: 10.1016/j.sleep.2024.09.025
Megha Agarwal , Amit Singhal
Cyclic alternating patterns (CAP) occur in electroencephalogram (EEG) signals during non-rapid eye movement sleep. The analysis of CAP can offer insights into various sleep disorders. The first step is the identification of phases A and B for the CAP cycles. In this work, we develop an easy-to-implement accurate system to differentiate between CAP A and CAP B. Small segments of the EEG signal are processed using Gaussian filters to obtain sub-band components. Features are extracted using some statistical characteristics of these signal components. Minimum redundancy maximum relevance test is employed to identify the more significant features. Three different machine learning classifiers are considered and their performance is compared. The results are analyzed for both the balanced and unbalanced datasets. The k-nearest neighbour (kNN) classifier achieves 79.14 % accuracy and F-1 score of 79.24 % for the balanced dataset. The proposed method outperforms the existing methods for CAP classification. It is easy-to-implement and can be considered as a candidate for real-time deployment.
在非快速眼动睡眠期间,脑电图(EEG)信号中会出现循环交替模式(CAP)。对 CAP 的分析可以帮助人们了解各种睡眠障碍。第一步是确定 CAP 周期的 A 相和 B 相。在这项工作中,我们开发了一种易于实施的精确系统来区分 CAP A 和 CAP B。利用这些信号分量的一些统计特征提取特征。采用最小冗余最大相关性测试来识别更重要的特征。考虑了三种不同的机器学习分类器,并对其性能进行了比较。对平衡和不平衡数据集的结果进行了分析。在平衡数据集上,k-近邻(kNN)分类器的准确率达到 79.14%,F-1 得分为 79.24%。在 CAP 分类方面,所提出的方法优于现有方法。该方法易于实施,可作为实时部署的候选方法。
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引用次数: 0
Neither fifty percent slow-wave sleep suppression nor fifty percent rapid eye movement sleep suppression does impair memory consolidation 百分之五十的慢波睡眠抑制和百分之五十的快速眼动睡眠抑制都不会影响记忆巩固
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-21 DOI: 10.1016/j.sleep.2024.09.031
Yulia V. Ukraintseva, Konstantin A. Saltykov, Olga N. Tkachenko
Establishing well-defined relationships between sleep features and memory consolidation is essential in comprehending the pathophysiology of cognitive decline commonly seen in patients with insomnia, depression, and other sleep-disrupting conditions.
Twenty-eight volunteers participated in two experimental sessions: a session with selective SWS suppression during one night and a session with undisturbed night sleep (as a control condition). Fifteen of them also participated in a third session with REM suppression. Suppression was achieved by presenting an acoustic tone. In the evening and the morning, the participants completed procedural and declarative memory tasks and the Psychomotor vigilance task (PVT). Heart rate variability analysis and salivary cortisol were used to control possible stress reactions to sleep interference.
SWS and REM suppression led to more than 50 percent reduction in the amount of these stages. Neither vigilance nor memory consolidation was impaired after SWS or REM suppression. Unexpectedly, a beneficial effect of selective SWS suppression on PVT performance was found. Similarly, after a night with SWS suppression, the overnight improvement in procedural skills was higher than after a night with REM suppression and after a night with undisturbed sleep.
Our data brings into question the extent to which SWS and REM are truly necessary for effective memory consolidation to proceed. Moreover, SWS suppression may even improve the performance of some tasks, possibly by reducing sleep inertia associated with undisturbed sleep.
建立睡眠特征与记忆巩固之间的明确关系,对于理解失眠、抑郁和其他睡眠障碍患者常见的认知能力下降的病理生理学至关重要。28名志愿者参加了两个实验环节:一个环节是在一个晚上选择性抑制SWS,另一个环节是不受干扰的夜间睡眠(作为对照条件)。其中 15 名志愿者还参加了第三轮快速眼动抑制实验。抑制是通过发出声音来实现的。在晚上和早上,参与者完成了程序性记忆和陈述性记忆任务以及精神运动警觉任务(PVT)。心率变异性分析和唾液皮质醇用于控制睡眠干扰可能带来的应激反应。SWS和REM抑制后,警觉性和记忆巩固均未受损。出乎意料的是,选择性抑制 SWS 对 PVT 表现产生了有利影响。同样,经过一夜的SWS抑制后,程序性技能在一夜之间的提高幅度要高于经过一夜的REM抑制后,以及经过一夜不受干扰的睡眠后。此外,抑制SWS甚至可能提高某些任务的表现,这可能是通过减少与无干扰睡眠相关的睡眠惰性实现的。
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引用次数: 0
Clinical tics and quality of life in children and adolescents with tic disorders: The mediating role of sleep 患有抽搐症的儿童和青少年的临床抽搐和生活质量:睡眠的中介作用
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-19 DOI: 10.1016/j.sleep.2024.09.030
Na Li , Xu Hong , Yonghua Cui , Ying Li

Background

Sleep conditions are important in children and adolescents with tic disorders. Psychiatric symptoms and tic symptoms themselves can detrimentally affect the quality of life (QOL) in individuals with tic disorders. However, there is currently a lack of explicit research evidence elucidating the relationship between sleep and the QOL in individuals with tic disorders.

Methods

We assessed 150 children/adolescents aged 4–14 years old diagnosed with tic disorders. Participants' tic symptoms were evaluated using the Yale Global Tic Severity Scale (YGTSS), while their sleep conditions were assessed using the Children's Sleep Habits Questionnaire (CSHQ), and quality of life was measured using the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL), all utilizing standardized measurement instruments. Detailed statistical descriptions, correlation analyses, and mediation analyses of the data were performed.

Results

We observed significant correlations among tic symptoms, sleep, and quality of life. Then, we confirmed the mediating role of sleep in the relationship between tic symptoms and quality of life (β = .591, 95%CI: .252–1.007). We also found that among different sleep variables, particularly bedtime resistance (β = .088, 95 % CI: .003–.260), played a significant mediating role.

Conclusions

Sleep was found to be a significantly mediator between tic symptoms and quality of life across various domains, especially bedtime resistance played an important mediating role. This indicates that assessment and management of sleep conditions in children/adolescents with tic disorders are important. These findings provide potentially valuable insights into the clinical evaluation of children and adolescents with tic disorders and the potential improvement of their quality of life in the future.
背景睡眠状况对患有抽搐症的儿童和青少年非常重要。精神症状和抽搐症状本身会对抽搐症患者的生活质量(QOL)产生不利影响。然而,目前还缺乏明确的研究证据来阐明抽搐症患者的睡眠与 QOL 之间的关系。方法我们对 150 名被诊断患有抽搐症的 4-14 岁儿童/青少年进行了评估。我们使用耶鲁全球抽搐严重程度量表(YGTSS)评估了参与者的抽搐症状,使用儿童睡眠习惯问卷(CSHQ)评估了他们的睡眠状况,使用吉勒-德拉图雷特综合征生活质量量表(GTS-QOL)测量了他们的生活质量。结果我们观察到抽动症状、睡眠和生活质量之间存在显著的相关性。然后,我们证实了睡眠在抽搐症状和生活质量之间的中介作用(β = .591,95%CI:.252-1.007)。我们还发现,在不同的睡眠变量中,尤其是就寝阻力(β = .088,95 % CI:.003-.260)起着重要的中介作用。结论研究发现,睡眠在抽搐症状和生活质量之间的各个领域都起着重要的中介作用,尤其是就寝阻力起着重要的中介作用。这表明,对患有抽搐症的儿童/青少年的睡眠状况进行评估和管理非常重要。这些发现为抽搐症儿童和青少年的临床评估以及未来改善他们的生活质量提供了潜在的宝贵见解。
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引用次数: 0
Sleep apnea-specific hypoxic burden and pulse rate response in children using high flow nasal cannula therapy compared with continuous positive airway pressure 与持续气道正压疗法相比,儿童使用高流量鼻插管疗法时的睡眠呼吸暂停特异性缺氧负担和脉率反应
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-19 DOI: 10.1016/j.sleep.2024.09.032
Chun Ting Au , Nobel Tsz Kin Yuen , Colin Massicotte , Kate Ching Ching Chan , Albert Martin Li , Indra Narang

Background

Elevated sleep apnea-specific hypoxic burden (HB) and pulse rate response (ΔHR) are associated with a higher cardiovascular risk in adults. The clinical significance of HB and ΔHR in children with obstructive sleep apnea (OSA) and their responses to therapy have not yet been investigated. This study aimed to compare the efficacy of high flow nasal cannula (HFNC) and continuous positive airway pressure (CPAP) in reducing HB and ΔHR in children.

Methods

This analysis included 17 children (11 males, mean age: 12.6 ± 3.9 years) with obesity and/or medical complexity and moderate-to-severe OSA. Each participant underwent two additional sleep studies: one for HFNC titration and another for CPAP titration. HB and ΔHR were derived from the oximetry and pulse rate signals from overnight sleep studies, respectively.

Results

Both HFNC and CPAP demonstrated significant reductions in HB from baseline, with similar magnitudes [HFNC: −129 (standard error, SE 55) %min/h, p = 0.003; CPAP: −138 (SE 53) %min/h, p = 0.005]. However, for ΔHR, a significant reduction from baseline was observed only in the CPAP group [–2.7 (SE 1.1) beats/min, p = 0.049], not the HFNC group [–1.0 (SE 1.4) beats/min, p = 0.67].

Conclusions

HFNC is as effective as CPAP in treating hypoxia in children with OSA, but HFNC might be less effective than CPAP in mitigating cardiovascular stress from autonomic disturbances during obstructive events.
背景睡眠呼吸暂停特异性缺氧负荷(HB)和脉率反应(ΔHR)升高与成人心血管风险升高有关。目前尚未研究阻塞性睡眠呼吸暂停(OSA)患儿的 HB 和 ΔHR 的临床意义及其对治疗的反应。本研究旨在比较高流量鼻插管(HFNC)和持续气道正压(CPAP)在降低儿童 HB 和 ΔHR 方面的疗效。方法本分析包括 17 名肥胖和/或病情复杂且患有中重度 OSA 的儿童(11 名男性,平均年龄:12.6 ± 3.9 岁)。每位参与者都接受了两次额外的睡眠研究:一次用于 HFNC 滴定,另一次用于 CPAP 滴定。HB 和 ΔHR 分别来自隔夜睡眠研究的血氧饱和度和脉搏信号。结果HFNC 和 CPAP 均显示 HB 从基线显著降低,降低幅度相似[HFNC:-129(标准误差,SE)]:HFNC:-129(标准误差,SE 55)%min/h,p = 0.003;CPAP:-138(标准误差,SE 53)%min/h,p = 0.003:CPAP:-138 (SE 53) %min/h,p = 0.005]。结论在治疗 OSA 患儿缺氧方面,HFNC 与 CPAP 一样有效,但在减轻阻塞事件期间自律神经紊乱对心血管造成的压力方面,HFNC 可能不如 CPAP 有效。
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引用次数: 0
Association between sleep disorder and depression in stroke in the National Health and Nutrition Examination Surveys (NHANES) 2005 to 2014 2005 年至 2014 年美国国家健康与营养调查(NHANES)中中风患者睡眠障碍与抑郁之间的关系
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-19 DOI: 10.1016/j.sleep.2024.09.021
Qinghua Wen , Juan Li , Simin Li , Xiaoyue Wang , Huanhuan Zhu , Fengyin Zhang

Background

To investigate the association between sleep disorder and depression in stroke population using data from the National Health and Nutrition Examination Surveys (NHANES) conducted between 2005 and 2014.

Methods

Participants included stroke population who reported on sleep disorder and completed the Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptom. Sleep disorder was self-reported and categorized dichotomously. Multivariate logistic regression, subgroup analysis, receiver operating characteristic curve (ROC) and restricted cubic spline (RCS) were used to explore the association between sleep disorder and depression.

Results

The final sample included 566 stroke survivors (weighted n = 3,326,625). Multivariate logistic regression analysis confirmed that sleep disorder was independently associated with an increased risk of depression even after adjusting for potential confounders (OR = 2.616, 95 % CI: 2.561 to 2.599, P < 0.0001). Subgroup analysis indicated that this association was particularly strong among female stroke population (OR = 5.515). Sleep disorder as a significant predictor of depression, while the relationship between sleep time and depression is characterized by non-linearity.

Conclusions

Sleep disorder is significantly associated with an increased risk of depression in stroke. This relationship remains robust across various sociodemographic and lifestyle factors, highlighting the need for integrated interventions targeting both sleep and mood disturbances in stroke care.
背景目的利用 2005 年至 2014 年间进行的美国国家健康与营养调查(NHANES)的数据,研究中风人群中睡眠障碍与抑郁症之间的关系。方法参与者包括报告睡眠障碍并完成患者健康问卷-9(PHQ-9)以评估抑郁症状的中风人群。睡眠障碍由患者自我报告,并以二分法进行分类。采用多变量逻辑回归、亚组分析、接收器操作特征曲线(ROC)和限制性立方样条曲线(RCS)来探讨睡眠障碍与抑郁症之间的关系。多变量逻辑回归分析证实,即使调整了潜在的混杂因素(OR = 2.616,95 % CI:2.561 至 2.599,P < 0.0001),睡眠障碍仍与抑郁风险增加有独立关联。亚组分析表明,这种关联在女性卒中人群中尤为明显(OR = 5.515)。睡眠障碍是抑郁的重要预测因素,而睡眠时间与抑郁之间的关系具有非线性特征。这种关系在各种社会人口和生活方式因素的影响下仍然保持稳定,这突出表明在中风护理中需要针对睡眠和情绪障碍采取综合干预措施。
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引用次数: 0
Cross-sectional and prospective associations between sleep health and multimorbidity in middle to older-aged adults: Results from the Canadian Longitudinal Study on Aging (CLSA) 中老年人睡眠健康与多病之间的横断面和前瞻性关联:加拿大老龄化纵向研究(CLSA)的结果
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-18 DOI: 10.1016/j.sleep.2024.09.029
Shreni Patel , Mark Speechley , Kathryn Nicholson , Osvaldo Espin-Garcia , Graham J. Reid , Saverio Stranges

Objective

Middle-aged to older adults often exhibit the co-existence of poor sleep health and multimorbidity. We examined cross-sectional and prospective associations of pooled index of sleep health with prevalent and incident multimorbidity in the framework of an ongoing cohort study in Canada.

Methods

Data were from approximately 24,000 individuals from the Canadian Longitudinal Study on Aging (CLSA), an ongoing national study of community-dwelling adults aged 45–85 years at baseline. Multimorbidity was defined as two or more chronic conditions out of five major condition categories. Sleep variables included sleep duration, quality, initiation, maintenance, and excessive daytime sleepiness, which were combined into an index using pooled approaches. Weighted logistic regression models were computed for each index with additional age- and sex-stratified analyses.

Results

Higher sleep index scores, indicating poorer sleep health, were observed in females and younger age groups (ages 45–54 and 55–64). In cross-sectional analysis, the fully adjusted model showed that a 1-unit increase in pooled scores was significantly associated with 1.48 higher odds (95 % CI = 1.38, 1.58; p < 0.001) of prevalent multimorbidity at baseline. Similarly, the prospective analysis indicated significant changes in incident multimorbidity with pooled index scores in the fully adjusted model (OR = 1.33; 95 % CI = 1.20, 1.48; p < 0.001).

Conclusion

The pooled sleep index introduced in this study may offer a novel, concise, and comprehensive approach to assessing sleep health among middle-aged and older adults. Those in these age groups experiencing poorer sleep health are at a greater risk of prevalent multimorbidity, as well as of developing multimorbidity over time.
目的 中老年人往往同时存在睡眠质量差和多病症的问题。我们在加拿大一项正在进行的队列研究框架内,研究了睡眠健康综合指数与流行性和偶发性多病症之间的横断面和前瞻性关联。方法数据来自加拿大老龄化纵向研究(CLSA)中的约 24,000 人,该研究是一项正在进行的全国性研究,研究对象为基线年龄在 45-85 岁之间、居住在社区的成年人。多病症的定义是在五种主要疾病类别中患有两种或两种以上慢性疾病。睡眠变量包括睡眠时间、睡眠质量、睡眠开始时间、睡眠维持时间和白天过度嗜睡,这些变量采用集合方法合并成一个指数。结果 女性和年轻年龄组(45-54 岁和 55-64 岁)的睡眠指数得分较高,表明睡眠健康状况较差。在横断面分析中,完全调整模型显示,集合得分每增加 1 个单位,基线多病流行几率就会增加 1.48(95 % CI = 1.38, 1.58; p <0.001)。同样,前瞻性分析表明,在完全调整模型中,随着集合指数得分的增加,多发病的发生率也会发生显著变化(OR = 1.33; 95 % CI = 1.20, 1.48; p <0.001)。在这些年龄组中,睡眠健康状况较差的人患多种疾病的风险更大,随着时间的推移,患多种疾病的风险也更大。
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引用次数: 0
Expanded gray matter atrophy with severity stages of adult comorbid insomnia and sleep apnea 灰质萎缩扩大与成人合并失眠和睡眠呼吸暂停的严重程度有关
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-18 DOI: 10.1016/j.sleep.2024.09.027
Liping Pan , Hui Li , Jiawei Guo , Chao Ma , Liming Li , Wenfeng Zhan , Huiyu Chen , Yuting Wu , Guihua Jiang , Shumei Li

Objective

To investigate gray matter volume (GMV) changes in patients with comorbid insomnia and sleep apnea (COMISA) of differing severity and relationships between GMV alterations and clinical measures.

Methods

Thirty-four COMISA patients and 24 healthy controls (HC) were recruited. All patients underwent structural MRI and completed measures related to respiration, sleep, mood, and cognition. COMISA patients were further divided into a mild and moderate COMISA (MC) and a severe COMISA (SC) group. Changes in GMV of COMISA patients were investigated via VBM. The voxel-wise differences in GMV were compared between HC group and COMISA group. Analysis of covariance (ANCOVA) was performed on individual GMV maps in MC, SC, and HC groups to further investigate effects of different stages of COMISA severity on GMV. Partial correlation analysis was then performed to analyze relationships between altered GMV and clinical measures.

Results

GMV atrophy was mainly located in the temporal lobes and fusiform gyrus in COMISA group. The post-hoc analysis of the ANCOVA revealed temporal lobes and fusiform gyrus atrophy in MC and SC groups compared to HC and the temporal lobe atrophy was expanded in SC group based on cluster size. Moreover, the SC group showed GMV atrophy of the right amygdala compared to both MC and HC groups. Partial correlation analysis revealed positive relationships between the GMV and mood-and cognitive-related measures and negative correlation between GMV and respiration measure.

Conclusions

Our findings showed GMV atrophy expansion from temporal lobe to limbic system (right amygdala) as severity stages increase in COMISA patients. These findings contribute to our understanding of neurobiological mechanisms underlying different stages of severity in COMISA patients.
方法招募 34 名 COMISA 患者和 24 名健康对照组(HC)。所有患者均接受了结构性核磁共振成像检查,并完成了与呼吸、睡眠、情绪和认知相关的测量。COMISA患者被进一步分为轻度和中度COMISA(MC)组以及重度COMISA(SC)组。通过 VBM 研究了 COMISA 患者 GMV 的变化。比较了 HC 组和 COMISA 组 GMV 的体素差异。对 MC 组、SC 组和 HC 组的单个 GMV 图进行协方差分析(ANCOVA),以进一步研究 COMISA 严重程度的不同阶段对 GMV 的影响。结果GMV萎缩主要位于COMISA组的颞叶和纺锤形回。方差分析的事后分析表明,与 HC 相比,MC 组和 SC 组的颞叶和纺锤形回萎缩,且根据聚类大小,SC 组的颞叶萎缩范围扩大。此外,与 MC 组和 HC 组相比,SC 组显示右侧杏仁核 GMV 萎缩。我们的研究结果表明,随着 COMISA 患者病情严重程度的增加,GMV 萎缩范围从颞叶扩展到边缘系统(右侧杏仁核)。这些发现有助于我们了解COMISA患者不同严重阶段的神经生物学机制。
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引用次数: 0
Kairos positive airway pressure (KPAP) equals continuous PAP in effectiveness, and offers superior comfort for obstructive sleep apnea treatment 凯罗斯气道正压(KPAP)的效果与持续气道正压相同,为阻塞性睡眠呼吸暂停的治疗提供卓越的舒适性
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-18 DOI: 10.1016/j.sleep.2024.09.028
David P. White , Ludovico Messineo , Evelyn Thompson , Bryan Hughes , Wilson D. Lannom , Bernard Hete , Abinash Joshi , William H. Noah

Study objectives

A recent study challenged the prevailing clinical view that maintaining inspiratory positive airway pressure (IPAP) is necessary for upper airway patency, demonstrating no differences in apnea hypopnea index (AHI) between continuous PAP (CPAP) with and without a resistor to reduce IPAP. In this study, we assessed the effect of Kairos PAP (KPAP), a new algorithm which features multiple drops in IPAP, only returning to therapeutic pressure near the end expiration, on sleep apnea severity and subjective comfort.

Methods

Two randomized clinical trials were conducted. In the Efficacy trial, the effect of KPAP vs. CPAP on AHI in PAP-treated OSA patients was examined using a split-night design, adjusting for period, sequence and fraction of supine sleep (mixed models). Unintentional leak differences between treatments were also examined. Exploratory analyses assessed the effect of KPAP vs. CPAP on key polysomnography outcomes. In the Comfort trial, we tested subjective preference for KPAP vs. CPAP at 9 and 13 cmH2O in PAP-naïve OSA patients.

Results

In the Efficacy trial (N = 48), KPAP reduced AHI more than CPAP (mean difference [95%CI]: −0.5 [−0.8, −0.2] events/h, P = 0.007). Unintentional leak was also reduced by over 50 % (−2.5 [−3.2, −1.7] L/min, P < 0.001). No significant change was observed in the exploratory variables assessed. In the Comfort trial (N = 150), 69 [61, 77] % and 84 [77, 89] % of participants preferred KPAP over CPAP at 9 and 13 cmH2O, respectively (P < 0.001).

Conclusions

KPAP is as effective as CPAP in reducing respiratory events, but is more comfortable and potentially better tolerated.
研究目的最近的一项研究对维持吸气气道正压 (IPAP) 是上气道通畅所必需的这一普遍临床观点提出了质疑,研究结果表明,在使用和不使用电阻器降低 IPAP 的连续气道正压 (CPAP) 之间,呼吸暂停低通气指数 (AHI) 没有差异。在本研究中,我们评估了 Kairos PAP (KPAP) 对睡眠呼吸暂停严重程度和主观舒适度的影响。在 "疗效 "试验中,采用分夜设计考察了 KPAP 与 CPAP 对经 PAP 治疗的 OSA 患者 AHI 的影响,并对仰卧睡眠的时间、顺序和比例进行了调整(混合模型)。此外,还研究了不同治疗方法之间的无意泄漏差异。探索性分析评估了 KPAP 与 CPAP 对主要多导睡眠图结果的影响。在舒适度试验中,我们测试了 PAP 不适用的 OSA 患者对 KPAP 与 CPAP 在 9 和 13 cmH2O 条件下的主观偏好。无意泄漏也减少了 50% 以上(-2.5 [-3.2, -1.7] L/min,P = 0.001)。在所评估的探索性变量中未观察到明显变化。在舒适度试验(N = 150)中,分别有 69 [61, 77] % 和 84 [77, 89] % 的参与者更喜欢 KPAP 而不是 9 和 13 cmH2O 的 CPAP(P < 0.001)。
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引用次数: 0
Clinical efficacy and safety of IV ferric carboxymaltose in restless legs syndrome: A meta-analysis of 537 patients 静脉注射羧甲基亚铁治疗不安腿综合征的临床疗效和安全性:对 537 名患者的荟萃分析
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-18 DOI: 10.1016/j.sleep.2024.09.017
Syeda Nimra Qadri , Saifullah Jamil , Subhan Zahid , Tehreem Asghar , Syeda Muzna Gillani , Soban Ali Qasim , Tilyan Kambar , Zain Ul Abideen , Usama Brohi , Sammon Khan Tareen , Palay Khan Tareen , Sandhya Kumari , Satesh Kumar , Mahima Khatri

Background

Recent research indicates that intravenous ferric carboxymaltose (IV FCM) presents a promising solution for Restless Legs Syndrome (RLS), distinguishing itself from other iron sources with minimal to no adverse effects. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety profile of administering IV FCM in patients with RLS, assuming that RLS and Iron deficiency anemia (IDA) are correlated.

Methodology

This study was conducted according to the PRISMA guideline, with search conducted on PubMed, Google Scholar, and the Medline library. Data was extracted from each study regarding RLS and the effect of IV FCM on it, while analysis was conducted on Review Manager Software.

Results

This meta-analysis comprises of 7 randomized controlled trials (RCTs). All 7 studies reported international RLS severity scale (IRLS) and the pooled analysis revealed a significant reduction in IRLS score favoring IV FCM [WMD: −6.03, 95 % CI (−10.11, −1.96), p = 0.004]. 3 out of 7 studies reported short form-36 health survey (SF-36) and the pooled analysis revealed that the total score of SF-36 significantly favors the group taking IV FCM [WMD: 7.44, 95%CI (1.67, 13.20) p = 0.01]. 4 out of 7 studies reported visual analogue scale (VAS) for RLS severity and pooled analysis revealed that IV FCM significantly decreased VAS) of RLS severity score as compared to the control [MD -19.21, 95%CI (−31.90, −6.52) p0.003].

Conclusion

The study findings support the efficacy of IV FCM in reducing the severity of RLS symptoms. Significant improvements in the IRLS scores were observed, alongside enhancements in overall quality of life measured by SF-36 scores.
背景最近的研究表明,静脉注射羧甲基亚铁(IV FCM)是治疗不宁腿综合症(RLS)的一种很有前景的方法,它有别于其他铁源,不良反应极小甚至没有。假定 RLS 与缺铁性贫血 (IDA) 相关,我们进行了一项系统回顾和荟萃分析,以评估静脉注射 FCM 对 RLS 患者的疗效和安全性。从每项研究中提取有关 RLS 及其静脉输注 FCM 效果的数据,并使用 Review Manager 软件进行分析。结果这项荟萃分析包括 7 项随机对照试验 (RCT)。所有 7 项研究都报告了国际 RLS 严重程度量表(IRLS),汇总分析显示,静脉输注 FCM 可显著降低 IRLS 评分[WMD:-6.03,95 % CI (-10.11, -1.96), p = 0.004]。7 项研究中有 3 项报告了短表-36 健康调查(SF-36),汇总分析表明,SF-36 总分明显有利于静脉输注 FCM 组[WMD:7.44,95%CI(1.67,13.20),p = 0.01]。7 项研究中有 4 项报告了 RLS 严重程度的视觉模拟量表(VAS),汇总分析显示,与对照组相比,静脉输注 FCM 能明显降低 RLS 严重程度的 VAS 评分[MD -19.21,95%CI (-31.90, -6.52) p0.003]。研究结果表明,IRLS 评分有明显改善,SF-36 评分衡量的整体生活质量也有所提高。
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引用次数: 0
Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial 无论是否同时使用警戒剂,每晚一次的羟苯甲酸钠(FT218)对嗜睡症患者白天症状的疗效:REST-ON 3 期试验的事后分析
IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-09-17 DOI: 10.1016/j.sleep.2024.09.024
Yves Dauvilliers , Thomas Roth , Richard Bogan , Michael J. Thorpy , Anne Marie Morse , Asim Roy , Jennifer Gudeman

Objective/Background

Extended-release, once-nightly sodium oxybate (ON-SXB) significantly improved narcolepsy symptoms in participants in the phase 3, randomized, double-blind, placebo-controlled REST-ON trial. This post hoc analysis of REST-ON data evaluated ON-SXB efficacy in participants with or without concomitant alerting agent use.

Patients/methods

Participants with narcolepsy aged >16 years were randomized 1:1 to ON-SXB (week 1: 4.5 g, weeks 2–3: 6 g, weeks 4–8: 7.5 g, weeks 9–13: 9 g) or placebo. Primary endpoints in this post hoc analysis included change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) rating, and number of weekly cataplexy episodes. The secondary endpoints were change from baseline in the Epworth Sleepiness Scale (ESS) score and in objective and subjective disrupted nighttime sleep parameters. Post hoc analyses assessed participants with and without alerting agent use across 6-, 7.5-, and 9-g doses.

Results

In the modified intent-to-treat population, 119 (63 %) were (ON-SXB, n = 66; placebo, n = 53) and 71 (37 %) were not (ON-SXB, n = 31; placebo, n = 40) taking alerting agents. Regardless of alerting agent use, treatment with ON-SXB resulted in significant improvements vs placebo (all doses, P < 0.05) for MWT, CGI-I, and number of weekly cataplexy episodes. Significant improvements in ESS (all doses, P < 0.05) with ON-SXB vs placebo were observed in the alerting agent use cohort. Directional improvements in ESS were reported with all doses in the no alerting agent use group.

Conclusions

Regardless of concomitant alerting agent use, ON-SXB improved daytime and nighttime narcolepsy symptoms vs placebo.
目的/背景在第 3 期随机、双盲、安慰剂对照 REST-ON 试验中,每晚一次的羟苯甲酸钠缓释片(ON-SXB)能显著改善参与者的嗜睡症症状。这项REST-ON试验数据的事后分析评估了ON-SXB对同时使用或不使用警戒剂的参与者的疗效。患者/方法年龄为16岁的嗜睡症患者按1:1的比例随机接受ON-SXB(第1周:4.5克,第2-3周:6克,第4-8周:7.5克,第9-13周:9克)或安慰剂治疗。这项事后分析的主要终点包括维持清醒测试(MWT)的平均睡眠潜伏期、临床总体印象改善(CGI-I)评分和每周惊厥发作次数与基线相比的变化。次要终点是埃普沃思嗜睡量表(ESS)评分以及客观和主观夜间睡眠紊乱参数与基线相比的变化。结果在修改后的意向治疗人群中,119 人(63%)服用(ON-SXB,n = 66;安慰剂,n = 53),71 人(37%)未服用(ON-SXB,n = 31;安慰剂,n = 40)警示剂。无论是否使用警戒剂,使用 ON-SXB 与安慰剂相比(所有剂量,P < 0.05),MWT、CGI-I 和每周惊厥发作次数均有显著改善。在使用警戒剂的队列中,ON-SXB与安慰剂相比,ESS有明显改善(所有剂量,P< 0.05)。结论无论是否同时使用警戒剂,ON-SXB 与安慰剂相比都能改善白天和夜间的嗜睡症状。
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Sleep medicine
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