Sleep Latency

睡眠延迟
  • 文章类型: Clinical Trial Protocol
    背景:轮班工人患睡眠障碍的风险增加。推荐用于睡眠障碍的标准疗法是失眠症的认知行为疗法(CBT-I)。它的许多干预措施都是基于规律的睡眠和觉醒节奏,很难申请轮班工人。因此,我们开发了专门针对轮班工人的新治疗手册(CBT-I-S),这应该更适合他们的需求。特别是,所有需要规律性的干预措施都已被删除,相反,在我们的初步研究中,针对被证明与睡眠相关的因素的干预措施已被整合.我们现在要测试本手册的有效性。
    方法:将进行N=142的随机对照试验,以比较两种情况:新开发的治疗手册将在实验组中进行,而失眠的认知行为疗法将用于标准组。两种治疗都将通过MSTeams在线进行,每组七个疗程。将在三个测量点收集数据(前,post,6个月随访),并使用线性混合模型进行分析。该研究将调查这两种治疗方法是否显著改善了总睡眠时间,睡眠发作潜伏期,轮班工人的主观睡眠质量和白天嗜睡。它还将检查新疗法手册是否优于轮班工人的标准疗法,以及这些效果是否稳定。
    结论:我们假设旨在解决抑郁情绪的干预措施,焦虑,担心,沉思,功能失调的思维模式和对睡眠的态度也会改善睡眠。如果真是这样,这些干预措施可以取代以前需要规律性的干预措施。这可以显着改善轮班工人失眠的治疗。
    背景:德国临床试验注册DRKSDRKS00032086。2023年8月16日注册。
    BACKGROUND: Shift workers are at an increased risk of developing sleep disorders. The standard therapy recommended for sleep disorders is cognitive behavioural therapy for insomnia (CBT-I). Many of its interventions are based on a regular sleep and wake rhythm, which is difficult to apply for shift workers. We have therefore developed a new therapy manual specifically for shift workers (CBT-I-S), which should be more applicable to their needs. In particular, all interventions that require regularity have been removed, and instead, interventions that address factors that proved to be relevant to sleep in our preliminary study have been integrated. We now want to test this manual for its effectiveness.
    METHODS: A randomised controlled trial with N = 142 will be conducted to compare two conditions: the newly developed therapy manual will be carried out in the experimental group, while cognitive behavioural therapy for insomnia will be employed in the standard group. Both treatments will be conducted online via MS Teams in a group setting with seven sessions each. Data will be collected at three measurement points (pre, post, 6-month follow-up) and analysed using linear mixed models. The study will investigate whether the two treatments have led to significant improvements in total sleep time, sleep onset latency, subjective sleep quality and daytime sleepiness in shift workers. It will also examine whether the new therapy manual is superior to standard therapy in shift workers and whether these effects are stable.
    CONCLUSIONS: We assume that interventions designed to address depressive mood, anxiety, worry, rumination, dysfunctional thought patterns and attitudes towards sleep will also improve sleep. If this is indeed the case, these interventions could replace previous ones that require regularity. This could significantly improve the treatment of insomnia in shift workers.
    BACKGROUND: German Clinical Trials Registry DRKS DRKS00032086 . Registered on August 16, 2023.
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  • 文章类型: Journal Article
    目的:已知MSLT结果受多种因素影响,包括睡眠时间,夜间觉醒的频率,和药物摄入量。虽然是睡眠和觉醒的主要同步器,没有检查日光持续时间对MSLT的影响。伯灵顿,佛蒙特州,美国在白天经历了巨大的变化,范围从8小时50分钟到15小时33分钟的日光。这项研究的目的是检验以下假设:在短日光下进行的MSLTs会受到光周期持续时间的影响(短日光研究,SDS)与长日光(长日光研究,LDS)从2013年到2023年在我们的睡眠实验室。
    方法:我们从我们的数据库中鉴定并分析了37SDS(日光530-560分钟)和36LDS(日光903-933分钟)。使用非配对学生T检验比较SDS和LDS结果组,卡方与非参数MannWhitneyU检验。
    结果:LDS的平均日光持续时间为15小时18±14.6分钟,SDS的平均日光持续时间为8小时57±18分钟。两组在年龄上没有差异,性别,研究患者的BMI和种族。MSLT之前的PSG期间的平均总睡眠时间和睡眠效率,和MSLT平均睡眠开始潜伏期两组没有显着差异。然而,SDSMSLT午睡有明显更多的睡眠开始REM期(SOREMP),SDS和LDS组MSLT期间捕获的SOREMP数量分布不同。SDS和LDS结果的差异与过夜PSG的睡眠结构无关,因为分析了睡眠和REM潜伏期以及N1,N2,REM的相对百分比,和N3在SDS和LDS之间没有显着差异。两组在N1和REM睡眠期间的唤醒指数存在差异。
    结论:日光持续时间可能会影响MSLT结果,在MSLT解释中应考虑。在MSLT指南中可以考虑对光周期的关注,如果我们的结果在更大的样本中复制。
    OBJECTIVE: MSLT results are known to be affected by multiple factors including sleep time, frequency of nighttime arousals, and medications intake. Although being the main synchronizer of sleep and wakefulness, daylight duration effects on MSLT have not been examined. Burlington, Vermont, USA experiences great variations in daylight duration, ranging from 8 h 50 min to 15 h 33 min of daylight. The aim of this study was to test the hypothesis that there would be photoperiod duration effects on MSLTs performed during short daylight (short daylight studies, SDS) vs. long daylight (long daylight studies, LDS) from 2013 to 2023 in our sleep laboratory.
    METHODS: We identified and analyzed 37 SDS (daylight 530-560 min) and 36 LDS (daylight 903-933 min) from our database. Groups of SDS and LDS results were compared using non-paired student T test, Chi-Square and non-parametric Mann Whitney U Test.
    RESULTS: Average daylight duration was 15 h 18 ± 14.6 min for LDS and 8 h 57 ± 18 min for SDS. Two groups did not differ in terms of the age, gender, BMI and race of patients studied. Mean total sleep time and sleep efficiency during PSG preceding MSLT, and MSLT mean sleep onset latency did not significantly differ for the two groups. However, SDS MSLT naps had significantly more sleep onset REM periods (SOREMP), and distribution of the number of SOREMP captured during MSLT was different for SDS and LDS groups. Differences of SDS and LDS results did not relate to sleep architecture of the overnight PSG as analysis of sleep and REM latency and relative percentages of N1, N2, REM, and N3 was not significantly different between SDS and LDS. The two groups showed difference in arousal indexes during N1 and REM sleep.
    CONCLUSIONS: Daylight duration may impact MSLT results and should probably be accounted for in MSLT interpretation. Attention to photoperiod could be considered in MSLT guidelines, if our results are replicated in larger samples.
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  • 文章类型: Journal Article
    由于消防员的工作和轮班时间表的心理和生理强度,他们的睡眠经常受到损害。花生酱价格实惠,是单不饱和脂肪酸的重要来源,这可能有助于睡眠健康。因此,这项研究旨在确定在睡前7周每天食用的花生酱是否会改变全职消防员的睡眠质量和数量。40名消防员(花生酱组=20;对照组=20)参加了这项为期八周的随机对照试验。所有参与者都填写了一份关于情绪的主观问卷,焦点,每天两次警觉性,并戴上Actigraph手表来测量睡眠变量,包括延迟,效率,时间在床上,时间睡着了,入睡后醒来,觉醒的次数,和清醒的时间。基线一周后,花生酱小组在睡前两小时吃了两汤匙花生酱,持续了七个星期。与对照组相比,花生酱组的睡眠测量值或主观情绪没有显着变化(p>0.05),焦点,或服用花生酱七周后的警觉。因此,花生酱作为花生的来源并没有改变这群消防员的睡眠质量或数量。
    Sleep is often impaired in firefighters due to the psychologically and physiologically intense nature of their work and working shift schedules. Peanut butter is affordable and a substantial source of monounsaturated fatty acids, which may aid sleep health. Thus, this study sought to determine if a daily serving of peanut butter consumed before bedtime for seven weeks altered sleep quality and quantity among full-time firefighters. Forty firefighters (peanut butter group = 20; control group = 20) participated in this eight-week randomized controlled trial. All participants completed a subjective questionnaire on mood, focus, and alertness twice daily and wore an Actigraph wristwatch to measure sleep variables, including latency, efficiency, time in bed, time asleep, wake after sleep onset, number of awakenings, and time spent awake. After a baseline week, the peanut butter group consumed two tablespoons of peanut butter two hours prior to bedtime for seven weeks. Compared to the control group, the peanut butter group did not demonstrate significant changes (p > 0.05) in sleep measures or subjective feelings of mood, focus, or alertness after consuming peanut butter for seven weeks. Therefore, peanut butter as a source of peanuts did not alter sleep quality or quantity in this group of firefighters.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    双耳搏动(BB)已被研究为提高睡眠质量的潜在方式。在这项研究中,我们引入了一种新形式的BB,称为动态BB(DBB),它包含了左耳和右耳之间动态变化的载波频率差异。具体来说,右耳的载波频率在一段时间内在100到103Hz之间变化,而左耳固定在100Hz,产生0到3Hz的频率差范围。这项研究的目的是研究DBB对睡眠质量的影响。10名健康参与者被纳入交叉设计,他们在连续两个晚上都经历了DBB和SHAM(没有声音)状况,多导睡眠图评估。在睡前开始期间施用DBB,睡眠发作,从快速眼动(REM)过渡到非REM阶段。与SHAM条件相比,DBB显着减少了睡眠延迟。心电图分析显示,在睡眠前开始和睡眠开始期间,暴露于DBB导致心率变异性降低。伴随着睡眠开始期间心率的低频功率降低。DBB可能有效改善睡眠质量,提示其在失眠治疗中的可能应用。
    Binaural beat (BB) has been investigated as a potential modality to enhance sleep quality. In this study, we introduce a new form of BB, referred to as dynamic BB (DBB), which incorporates dynamically changing carrier frequency differences between the left and right ears. Specifically, the carrier frequency of the right ear varied between 100 and 103 Hz over a period, while the left ear remained fixed at 100 Hz, yielding a frequency difference range of 0 to 3 Hz. The objective of this study was to examine the effect of DBB on sleep quality. Ten healthy participants were included in a cross-over design, where they experienced both DBB and a SHAM (absence of sound) condition across two consecutive nights, with polysomnography evaluation. DBB was administrated during pre-sleep initiation, sleep onset, and transition from rapid-eye-movement (REM) to non-REM stage. DBB significantly reduced sleep latency compared to the SHAM condition. Electrocardiogram analysis revealed that exposure to DBB led to diminished heart rate variability during the pre-sleep initiation and sleep onset periods, accompanied by a decrease in low frequency power of heart rate during the sleep onset period. DBB might be effective in improving the sleep quality, suggesting its possible application in insomnia treatments.
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  • 文章类型: Journal Article
    目标:这项初步研究评估了电子噪声掩蔽耳塞对报告COVID-19大流行期间睡眠困难的医护人员(HCWs)的主观睡眠感知和客观睡眠参数的影响。方法:采用前置设计,77名医护人员接受了3晚的基线评估,随后进行了7晚的干预期。参与者佩戴家庭睡眠监测头带,以评估客观睡眠测量并完成主观自我报告评估。在线性混合模型中估计了从基线到干预的平均睡眠测量值的差异。结果:与基线评估相比,HCWs报告通过失眠严重程度指数(ISI)(Cohen'sd=1.74,p<0.001)测量的睡眠质量显着改善,并且在干预期间感知的睡眠开始潜伏期(SOL)显着减少(M=17.2分钟,SD=7.7)与基线相比(M=24.7分钟,SD=16.1),(科恩的d=-0.42,p=0.001)。客观SOL没有显著变化(p=0.703)。然而,基线目标SOL(<20分钟vs>20分钟)和条件(基线vs干预)之间存在显著交互作用(p=0.002),因此,与基线相比,客观SOL>20分钟的个体在干预期间经历了客观SOL的显著降低(p=0.015)。结论:使用电子噪声掩蔽耳塞后,HCWs的SOL和ISI评分显着改善。我们的数据为非药物干预以改善HCWs的睡眠质量提供了初步证据,这应该通过未来的对照研究得到证实。
    Objective: This pilot study assessed the effects of electronic noise-masking earbuds on subjective sleep perception and objective sleep parameters among healthcare workers (HCWs) reporting sleep difficulties during the COVID-19 pandemic. Methods: Using a pre-post design, 77 HCWs underwent 3 nights of baseline assessment followed by a 7-night intervention period. Participants wore an at-home sleep monitoring headband to assess objective sleep measures and completed subjective self-report assessments. The difference in mean sleep measures from baseline to intervention was estimated in linear mixed models. Results: Compared to baseline assessments, HCWs reported significant improvements in sleep quality as measured by the Insomnia Severity Index (ISI) (Cohen\'s d = 1.74, p < 0.001) and a significant reduction in perceived sleep onset latency (SOL) during the intervention (M = 17.2 minutes, SD = 7.7) compared to baseline (M = 24.7 minutes, SD = 16.1), (Cohen\'s d = -0.42, p = 0.001). There were no significant changes in objective SOL (p = 0.703). However, there was a significant interaction between baseline objective SOL (<20 minutes vs >20 minutes) and condition (baseline vs intervention) (p = 0.002), such that individuals with objective SOL >20 minutes experienced a significant decrease in objective SOL during the intervention period compared to baseline (p = 0.015). Conclusions: HCWs experienced a significant improvement in perceived SOL and ISI scores after using the electronic noise-masking earbuds. Our data provide preliminary evidence for a nonpharmacological intervention to improve the sleep quality of HCWs which should be confirmed by future controlled studies.
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  • 文章类型: Journal Article
    目的:睡眠状态可能与睡眠模式和睡眠结构有关,然而,证据相当有限。这项研究旨在通过一项大型流行病学研究来调查儿童睡眠异常症状与睡眠延迟之间的关系。
    方法:对21,704名3-11岁儿童进行了两轮横断面研究;一个在上海,另一个在三亚,海南省。使用儿童睡眠习惯问卷(CSHQ)评估儿童的睡眠特征。采用倾向得分匹配来平衡协变量的差异,并实施逻辑回归模型来检验失眠状态症状与睡眠发作延迟之间的关联.
    结果:总共38.2%的儿童出现睡眠延迟。Parasninas,特别是非快速眼动(NREM)和快速眼动(REM)的失眠症症状,与睡眠发作延迟的风险增加相关(睡眠行走:OR=1.55;睡眠恐怖:OR=1.34;噩梦:OR=1.37,均p=0.001)。在根据睡眠持续时间的分层分析中观察到类似的发现,在睡眠充足组(睡眠行走:OR=1.62;睡眠恐怖:OR=1.35;噩梦:OR=1.35,均p=0.001)。此外,观察到剂量依赖性模式,其中累积的失眠症症状与睡眠发作延迟的风险增加相关(2个症状:OR=1.19;≥3个症状:OR=1.40;与≤1个症状相比).在倾向评分匹配样本中也类似地观察到所有这些发现。此外,该协会通常在上海和三亚儿童中建立。
    结论:睡眠副睡眠症状与儿童睡眠延迟的高风险相关,而与睡眠时间无关。需要更多的研究来丰富目前的证据,从而进一步阐明不同睡眠参数之间的关联和相互作用。
    OBJECTIVE: Parasomnia is potentially implicated in sleep pattern and sleep architecture, however, evidence is quite limited. This study aimed to investigate the association between parasomnia symptoms and sleep onset delay among children through a large epidemiological study.
    METHODS: Two rounds of cross-sectional studies were conducted among 21,704 children aged 3-11; one taking place in Shanghai and the other in Sanya, Hainan province. Children\'s sleep characteristics were evaluated using the Children\'s Sleep Habits Questionnaire (CSHQ). Propensity score matching was adopted to balance the difference of covariates, and the logistic regression models were implemented to examine the associations between parasomnia symptoms and sleep onset delay.
    RESULTS: A total of 38.2 % of children had sleep onset delay. Parasomnias, especially non rapid eye movement (NREM) and rapid eye movement (REM) parasomnia symptoms, were associated with an increased risk of sleep onset delay (Sleep Walking: OR = 1.55; Sleep Terror: OR = 1.34; Nightmare: OR = 1.37, all p˂0.001). The similar findings were observed in stratified analyses according to sleep duration, and the association was pronounced in sleep sufficiency group (Sleep Walking: OR = 1.62; Sleep Terror: OR = 1.35; Nightmare: OR = 1.35, all p˂0.001). Moreover, a dose-dependent pattern was observed, in which cumulative parasomnia symptoms were associated with increasing risk of sleep onset delay (2 symptoms: OR = 1.19; ≥3 symptoms: OR = 1.40; by comparison with ≤1 symptom). All these findings were also similarly observed in the propensity score matching sample. Moreover, the associations were generally established in both Shanghai and Sanya children.
    CONCLUSIONS: Parasomnia symptoms were associated with a higher risk of sleep onset delay independently of sleep duration among children. More studies are needed to enrich the current evidence, thus further clarifying the association and interaction among different sleep parameters.
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  • 文章类型: Journal Article
    背景:越来越多的证据表明,特发性震颤(ET)患者存在认知障碍的高风险。认知障碍的预测因素尚未得到广泛研究。有来自横断面研究的证据表明,睡眠失调与ET的认知功能障碍有关,但是,关于睡眠中断对认知改变的影响的纵向研究尚未进行。我们调查了睡眠问题预测ET患者认知变化的程度。
    方法:ET病例纳入前瞻性,认知表现的纵向研究。使用匹兹堡睡眠质量指数(PSQI)评估睡眠质量。跨五个领域的认知能力(记忆,执行功能,注意,语言,和视觉空间能力),从广泛的神经心理学评估中提取了全局认知评分(域的平均值)。在间隔18个月的三个随访评估中,使用广义估计方程来检查基线睡眠问题与认知变化之间的关联。
    结果:188例非痴呆ET患者的平均年龄为77.7±9.5岁。较长的睡眠潜伏期与执行功能的纵向下降有关(p=0.038),与全球认知能力的纵向下降略有差异(p=0.075)。排除29例轻度认知障碍后,结果相似。
    结论:认知健康的ET患者睡眠潜伏期较长,在前瞻性随访期间执行功能下降幅度更大。及早发现,可能会干预,异常睡眠潜伏期可以防止ET患者认知功能下降的某些方面。
    BACKGROUND: There is growing evidence that essential tremor (ET) patients are at high risk of cognitive impairment. Predictors of cognitive impairment have not been studied extensively. There is evidence from cross-sectional studies that sleep dysregulation is associated with cognitive dysfunction in ET, but longitudinal studies of the impact of sleep disruption on cognitive change have not been conducted. We investigated the extent to which sleep problems predict cognitive change in patients with ET.
    METHODS: ET cases enrolled in a prospective, longitudinal study of cognitive performance. Sleep quality was assessed using the Pittsburg Sleep Quality Index (PSQI). Cognitive abilities across five domains (memory, executive function, attention, language, and visuospatial ability), and a global cognitive score (mean of the domains) were extracted from an extensive neuropsychological assessment. Generalized estimated equations were used to examine the association between baseline sleep problems and cognitive changes over three follow-up assessments each spaced 18 months apart.
    RESULTS: The 188 non-demented ET cases had a mean age of 77.7 ± 9.5 years. Longer sleep latency was associated with longitudinal decline in executive function (p = 0.038), and marginally with longitudinal decline in global cognitive performance (p = 0.075). After excluding 29 cases with mild cognitive impairment, results were similar.
    CONCLUSIONS: Cognitively healthy people with ET who have longer sleep latency had greater declines in executive function during prospective follow-up. Early detection of, and possibly intervention for, abnormal sleep latency may protect against certain aspects of cognitive decline in ET patients.
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  • 文章类型: Journal Article
    睡眠症状,包括过度困倦,经常由功能性运动障碍(FMD)患者报告。我们的目的是对口蹄疫共病睡眠障碍进行分类,并研究主观嗜睡与失眠的客观指标之间的关系,将它们与中心性失眠症患者的数据进行比较。共有37例临床明确口蹄疫患者(平均年龄46.4[11.2]岁),和17例患者(平均[SD]年龄41.1[11.6]岁)中心性睡眠过度经历了结构化医疗和睡眠史,神经系统检查,多导睡眠图,多睡眠延迟测试(MSLT),和评估嗜睡的问卷,疲劳,和抑郁症。总之,23例FMD患者(62%)报告白天过度嗜睡。在我们的队列中发现了特定睡眠障碍的证据,35%患有不宁腿综合征;49%的阻塞性睡眠呼吸暂停;8%的睡眠中周期性肢体运动;然而,这些疾病的存在与主观嗜睡无关.自我报告嗜睡的FMD患者报告疲劳较高(p=0.002),抑郁(p=0.002),与中心性睡眠过度患者相比,MSLT的睡眠潜伏期更长(p<0.001)。两组主观和客观嗜睡之间均无相关性。FMD患者的疲劳与自我报告的嗜睡呈正相关(p<0.001)。这项研究没有发现FMD患者嗜睡增加的客观相关因素。虽然发现睡眠异常在口蹄疫中很常见,他们与过度嗜睡的自我报告无关。自我报告的嗜睡与疲劳之间的正相关支持了当前FMD非运动症状的统一模型。
    Sleep symptoms, including excessive sleepiness, are frequently reported by patients with functional motor disorders (FMD). We aimed to classify the comorbid sleep disorders in FMD, and to investigate the relationship between subjective sleepiness and objective measures of hypersomnia, comparing them with data from people with central hypersomnia. A total of 37 patients (mean [SD] age 46.4 [11.2] years) with clinically definite FMD, and 17 patients (mean [SD] age 41.1 [11.6] years) with central hypersomnia underwent structured medical and sleep history, neurological examination, polysomnography, multiple sleep latency test (MSLT), and questionnaires assessing sleepiness, fatigue, and depression. In all, 23 patients with FMD (62%) reported excessive daytime sleepiness. Evidence of specific sleep disorders was identified in our cohort, with 35% having restless legs syndrome; 49% obstructive sleep apnea; and 8% periodic limb movements in sleep; however, the presence of these disorders was not correlated with subjective sleepiness. Patients with FMD with self-reported sleepiness reported higher fatigue (p = 0.002), depression (p = 0.002), and had longer sleep latencies in the MSLT (p < 0.001) compared to the patients with central hypersomnia. No correlation was found between subjective and objective sleepiness in either group. Fatigue positively correlated with self-reported sleepiness in patients with FMD (p < 0.001). This study did not find objective correlates of increased sleepiness in patients with FMD. While sleep abnormalities were found to be common in FMD, they were not correlated with self-reports of excessive sleepiness. Positive correlations between self-reported sleepiness and fatigue support the current unified model of non-motor symptoms in FMD.
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  • 文章类型: Clinical Trial Protocol
    目的:失眠是最常见的睡眠障碍,很少有有效的药物治疗。轶事报道和最近的临床前研究表明,大麻酚(CBN),一种源自δ-9-四氢大麻酚的大麻成分,可能是一种有效的治疗方法。尽管如此,CBN对睡眠的孤立影响尚未在人类中进行系统研究。
    方法:本协议文件描述了一个随机的,双盲,安慰剂对照,单剂量,三臂,cross-over,概念验证研究调查CBN对20名临床医生诊断为失眠障碍且失眠严重度指数评分≥15的参与者的睡眠和次日功能的影响。参与者接受30mgCBN的单一固定口服液体剂量,300毫克CBN和匹配的安慰剂,以随机顺序在三个治疗之夜;每个间隔2周的清洗期。参与者使用实验室多导睡眠图和第二天神经行为功能测试进行过夜睡眠评估。主要结果是睡眠开始几分钟后醒来。次要结果包括对传统睡眠分期的改变,非快速眼动(NREM)睡眠期间的睡眠发作延迟和绝对光谱功率。三级结果包括NREM睡眠期间睡眠纺锤波的变化,唤醒指数,REM睡眠期间的绝对频谱功率和主观睡眠质量。安全相关和探索性结果包括第二天模拟驾驶性能的变化,主观情绪和药物作用,姿势摇摆,警觉性和反应时间,过夜记忆巩固,睡前和睡后主观和客观嗜睡;和血浆,泌尿,和唾液大麻素浓度。这项研究将提供新的初步数据,CBN疗效和失眠障碍的安全性,这将为更大的临床试验提供信息。
    背景:人类研究伦理委员会已获得Bellberry(2021-08-907)的批准。研究结果将在同行评审的期刊和学术会议上传播。
    背景:NCT05344170。
    Insomnia is the most prevalent sleep disorder, with few effective pharmacotherapies. Anecdotal reports and recent preclinical research suggest that cannabinol (CBN), a constituent of Cannabis sativa derived from delta-9-tetrahydrocannabinol, could be an effective treatment. Despite this, the isolated effects of CBN on sleep have yet to be systematically studied in humans.
    The present protocol paper describes a randomised, double-blind, placebo-controlled, single-dose, three-arm, cross-over, proof-of-concept study which investigates the effects of CBN on sleep and next-day function in 20 participants with clinician-diagnosed insomnia disorder and an Insomnia Severity Index Score ≥15. Participants receive a single fixed oral liquid dose of 30 mg CBN, 300 mg CBN and matched placebo, in random order on three treatment nights; each separated by a 2-week wash-out period. Participants undergo overnight sleep assessment using in-laboratory polysomnography and next-day neurobehavioural function tests. The primary outcome is wake after sleep onset minutes. Secondary outcomes include changes to traditional sleep staging, sleep-onset latency and absolute spectral power during non-rapid eye movement (NREM) sleep. Tertiary outcomes include changes to sleep spindles during NREM sleep, arousal indices, absolute spectral power during REM sleep and subjective sleep quality. Safety-related and exploratory outcomes include changes to next-day simulated driving performance, subjective mood and drug effects, postural sway, alertness and reaction time, overnight memory consolidation, pre and post-sleep subjective and objective sleepiness; and plasma, urinary, and salivary cannabinoid concentrations. The study will provide novel preliminary data on CBN efficacy and safety in insomnia disorder, which will inform larger clinical trials.
    Human Research Ethics Committee approval has been granted by Bellberry (2021-08-907). Study findings will be disseminated in a peer-reviewed journal and at academic conferences.
    NCT05344170.
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