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Movement Disorders Clinical Practice Jul 2023Pain is common in Parkinson's disease (PD), but effective therapies are limited.
BACKGROUND
Pain is common in Parkinson's disease (PD), but effective therapies are limited.
OBJECTIVES
To determine the maximum tolerated dose (MTD) and safety of formulations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) for pain in PD.
METHODS
In this phase 1b, double-blind, randomized, single-center study, participants were randomized to three formulations of THC/CBD (18:0, 10:10, and 1:20). The MTD, adverse events (AE), and tolerability are described for each formulation.
RESULTS
Eight participants were randomized. The MTD was similar among groups (0.8-0.9 mL/daily), and there were no serious AE or study drop-outs. The most common AE were drowsiness and dizziness (three participants). Epworth sleepiness scale scores were higher in the high CBD formulation (1:20).
CONCLUSIONS
In patients with pain and PD, mixed formulations of THC/CBD were tolerated with no serious AE. Considering the safety profile, future phase II studies should be considered.
PubMed: 37476317
DOI: 10.1002/mdc3.13754 -
Cognitive Neurodynamics Oct 2023Driving a vehicle is a complex, multidimensional, and potentially risky activity demanding full mobilization and utilization of physiological and cognitive abilities.... (Review)
Review
Driving a vehicle is a complex, multidimensional, and potentially risky activity demanding full mobilization and utilization of physiological and cognitive abilities. Drowsiness, often caused by stress, fatigue, and illness declines cognitive capabilities that affect drivers' capability and cause many accidents. Drowsiness-related road accidents are associated with trauma, physical injuries, and fatalities, and often accompany economic loss. Drowsy-related crashes are most common in young people and night shift workers. Real-time and accurate driver drowsiness detection is necessary to bring down the drowsy driving accident rate. Many researchers endeavored for systems to detect drowsiness using different features related to vehicles, and drivers' behavior, as well as, physiological measures. Keeping in view the rising trend in the use of physiological measures, this study presents a comprehensive and systematic review of the recent techniques to detect driver drowsiness using physiological signals. Different sensors augmented with machine learning are utilized which subsequently yield better results. These techniques are analyzed with respect to several aspects such as data collection sensor, environment consideration like controlled or dynamic, experimental set up like real traffic or driving simulators, etc. Similarly, by investigating the type of sensors involved in experiments, this study discusses the advantages and disadvantages of existing studies and points out the research gaps. Perceptions and conceptions are made to provide future research directions for drowsiness detection techniques based on physiological signals.
PubMed: 37786662
DOI: 10.1007/s11571-022-09898-9 -
Journal of Neurology Nov 2023Sleep abnormalities have been reported in Charcot-Marie-Tooth disease (CMT), but data are scanty. We investigated their presence and correlation in a large CMT patients'...
BACKGROUND
Sleep abnormalities have been reported in Charcot-Marie-Tooth disease (CMT), but data are scanty. We investigated their presence and correlation in a large CMT patients' series.
METHODS
Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI) were administered to CMT patients of the Italian registry and controls. ESS score > 10 indicated abnormal daytime somnolence, PSQI score > 5 bad sleep quality. We analyzed correlation with disease severity and characteristics, Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS), Body Mass Index, drug use.
RESULTS
ESS and PSQI questionnaires were filled by 257 and 253 CMT patients, respectively, and 58 controls. Median PSQI score was higher in CMT patients than controls (6 vs 4, p = 0.006), with no difference for ESS score. Abnormal somnolence and poor sleep quality occurred in 23% and 56% of patients; such patients had more frequently anxiety/depression, abnormal fatigue, and positive sensory symptoms than those with normal ESS/PSQI. Moreover, patients with PSQI score > 5 had more severe disease (median CMT Examination Score, CMTES, 8 vs 6, p = 0.006) and more frequent use of anxiolytic/antidepressant drugs (29% vs 7%, p < 0.001).
CONCLUSIONS
Bad sleep quality and daytime sleepiness are frequent in CMT and correlated with anxiety, depression and fatigue, confirming that different components affect sleep. Sleep disorders, such as sleep apnea and restless leg syndrome, not specifically investigated here, are other factors known to impact on sleep quality and somnolence. CMT patients' management must include sleep behavior assessment and evaluation of its correlated factors, including general distress and fatigue.
Topics: Humans; Sleep Quality; Sleepiness; Charcot-Marie-Tooth Disease; Disorders of Excessive Somnolence; Sleep; Fatigue; Surveys and Questionnaires; Sleep Wake Disorders
PubMed: 37540277
DOI: 10.1007/s00415-023-11911-y -
Sleep Nov 2023To examine whether drivers are aware of sleepiness and associated symptoms, and how subjective reports predict driving impairment and physiological drowsiness.
STUDY OBJECTIVES
To examine whether drivers are aware of sleepiness and associated symptoms, and how subjective reports predict driving impairment and physiological drowsiness.
METHODS
Sixteen shift workers (19-65 years; 9 women) drove an instrumented vehicle for 2 hours on a closed-loop track after a night of sleep and a night of work. Subjective sleepiness/symptoms were rated every 15 minutes. Severe and moderate driving impairment was defined by emergency brake maneuvers and lane deviations, respectively. Physiological drowsiness was defined by eye closures (Johns drowsiness scores) and EEG-based microsleep events.
RESULTS
All subjective ratings increased post night-shift (p < 0.001). No severe drive events occurred without noticeable symptoms beforehand. All subjective sleepiness ratings, and specific symptoms, predicted a severe (emergency brake) driving event occurring in the next 15 minutes (OR: 1.76-2.4, AUC > 0.81, p < 0.009), except "head dropping down". Karolinska Sleepiness Scale (KSS), ocular symptoms, difficulty keeping to center of the road, and nodding off to sleep, were associated with a lane deviation in the next 15 minutes (OR: 1.17-1.24, p<0.029), although accuracy was only "fair" (AUC 0.59-0.65). All sleepiness ratings predicted severe ocular-based drowsiness (OR: 1.30-2.81, p < 0.001), with very good-to-excellent accuracy (AUC > 0.8), while moderate ocular-based drowsiness was predicted with fair-to-good accuracy (AUC > 0.62). KSS, likelihood of falling asleep, ocular symptoms, and "nodding off" predicted microsleep events, with fair-to-good accuracy (AUC 0.65-0.73).
CONCLUSIONS
Drivers are aware of sleepiness, and many self-reported sleepiness symptoms predicted subsequent driving impairment/physiological drowsiness. Drivers should self-assess a wide range of sleepiness symptoms and stop driving when these occur to reduce the escalating risk of road crashes due to drowsiness.
Topics: Humans; Female; Accidents, Traffic; Automobile Driving; Sleepiness; Wakefulness; Sleep
PubMed: 37158173
DOI: 10.1093/sleep/zsad136 -
Cureus Aug 2023Chronic kidney disease (CKD) causes various complications that significantly impact a patient's overall well-being and quality of life. Sleep disorders are a... (Review)
Review
Chronic kidney disease (CKD) causes various complications that significantly impact a patient's overall well-being and quality of life. Sleep disorders are a particularly common issue, especially in patients with advanced disease. This systematic review aims to explore the distinguishing features, prevalence rates, underlying causes, and associated factors related to the most frequent sleep disorders in these patients and present the latest treatment methods for them. It also investigates the link between CKD and sleep disorders and presents the results of the most common sleep disorders found in patients with CKD. Four major sleep disorders have been identified: sleep apnea, restless leg syndrome, excessive drowsiness, and insomnia. These sleep disorders have been discovered to be highly common in CKD patients and have a major influence on their quality of life and morbidity.
PubMed: 37746453
DOI: 10.7759/cureus.44009 -
Sleep Medicine Dec 2023Sleep disorders, including obstructive sleep apnea (OSA), restless leg syndrome (RLS) and insomnia, are present in chronic obstructive pulmonary disease (COPD) with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sleep disorders, including obstructive sleep apnea (OSA), restless leg syndrome (RLS) and insomnia, are present in chronic obstructive pulmonary disease (COPD) with varied prevalence. The aim of this systematic review and meta-analysis was to investigate prevalence of OSA, RLS and insomnia in patients with COPD and summarize their clinical characteristics.
METHODS
We searched PubMed, Web of Science and Scopus for eligible articles reporting the prevalence of OSA, RLS, and insomnia in COPD patients. The Newcastle‒Ottawa scale was applied for quality assessment. Odds ratios or mean differences with 95 % confidence intervals (CIs) were applied for the overall prevalence calculation and clinical characteristics assessment. Sensitivity analysis, subgroup analysis and meta-regression were conducted to evaluate the heterogeneity of the results.
RESULTS
Sixty articles reporting the prevalence of sleep disorders in patients with COPD were included, and the prevalence of OSA, RLS, and insomnia reached 29.1 %(95%CI 27.2%-30.9 %), 21.6 %(95%CI 11.8%-33.3 %) and 29.5 %(95%CI 16.9%-44.0 %), respectively. COPD patients with OSA were characterized by male sex (OR 1.631 95 % CI: 1.231-2.161), obesity(kg/m) (MD 4.435, 95 % CI 3.218-5.652), higher Epworth Sleepiness Scale (MD: 3.741, 95 % CI: 0.655-6.828, p = 0.018), better pulmonary function (MD 5.66, 95 % CI 3.546-7.774) and higher risks of hypertension (OR 1.933 95 % CI 1.382-2.70) and diabetes (OR 1.898 95 % CI 1.264-2.849). COPD patients with RLS were associated with a higher Epworth sleepiness scale (ESS) score (MD 3.444, 95 % CI 1.880-5.008) and a longer COPD duration(year) (MD: 3.656, 95 % CI: 2.209-5.103). COPD patients with insomnia were characterized by female sex(OR 0.556, 95%CI 0.545,0.567, p < 0.001).
CONCLUSION
Our study suggests that OSA, RLS and insomnia are common in COPD patients with specific clinical characteristics. Further studies are needed to explore the interactions between COPD and sleep disorders.
Topics: Humans; Male; Female; Sleep Initiation and Maintenance Disorders; Prevalence; Sleepiness; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Sleep Wake Disorders; Restless Legs Syndrome
PubMed: 37950939
DOI: 10.1016/j.sleep.2023.10.034 -
Journal of Sleep Research Oct 2023The orexin 2 receptor-selective agonist danavorexton (TAK-925) has been shown to produce wake-promoting effects in wild-type mice, narcolepsy-model mice, and individuals... (Randomized Controlled Trial)
Randomized Controlled Trial
The orexin 2 receptor-selective agonist danavorexton (TAK-925) has been shown to produce wake-promoting effects in wild-type mice, narcolepsy-model mice, and individuals with narcolepsy type 1 and type 2. Here, we report wake-promoting effects of danavorexton in non-human primates and healthy men during their sleep phase. Electroencephalogram analyses revealed that subcutaneous administration of danavorexton significantly increased wakefulness in common marmosets (p < 0.05 at 0.1 mg kg , and p < 0.001 at 1 mg kg and 10 mg kg ) and cynomolgus monkeys (p ≤ 0.05 at 1 mg kg and 3 mg kg ). In a phase 1b crossover, randomized, double-blind, placebo-controlled and active-controlled study in sleep-deprived healthy participants (ClinicalTrials.gov identifier: NCT03522506), modafinil 300 mg (used to demonstrate assay sensitivity) and continuous infusion of danavorexton 44 mg and danavorexton 112 mg showed statistically superior wake-promoting effects to placebo (n = 18). Measured using the Maintenance of Wakefulness Test, mean (standard deviation) sleep latencies during infusion of danavorexton 44 mg, danavorexton 112 mg and placebo were 21.4 (8.9), 31.8 (3.2) and 9.2 (6.4) min, respectively. Least-squares mean difference from placebo in average sleep latency was 16.8 min with danavorexton 44 mg and 30.2 min with danavorexton 112 mg (both p < 0.001). Karolinska Sleepiness Scale scores were statistically significantly lower (indicating decreased sleepiness) for participants receiving danavorexton than for those receiving placebo during infusion (danavorexton 44 mg, p = 0.010; danavorexton 112 mg, p < 0.001). Together, these results indicate that an orexin 2 receptor agonist increases wakefulness in non-human primates and healthy individuals during their sleep phase.
Topics: Animals; Double-Blind Method; Narcolepsy; Orexins; Primates; Sleepiness; Treatment Outcome; Wakefulness; Humans; Male
PubMed: 36934366
DOI: 10.1111/jsr.13878 -
Journal of Gastroenterology and... Aug 2023We aim to conduct a systematic review and determine the association between obstructive sleep apnea (OSA) and gastroesophageal reflux disease (GERD). (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIM
We aim to conduct a systematic review and determine the association between obstructive sleep apnea (OSA) and gastroesophageal reflux disease (GERD).
METHODS
Literature search for eligible studies was performed across major databases. The main endpoint was to assess the association between GERD and OSA. Subgroup analyses were performed to determine this strength of the association stratified by the diagnostic tools used for OSA (nocturnal polysomnogram or Berlin questionnaire) and GERD (validated reflux questionnaire or esophagogastroduodenoscopy). We also compared sleep efficiency, apnea hypopnea index, oxygen desaturation index, and Epworth Sleepiness Scale in OSA patients with or without GERD. Results were pooled together using Reviewer Manager 5.4.
RESULTS
Six studies involving 2950 patients with either GERD or OSA were included in the pooled analysis. Our findings suggest that there was a statistically significant unidirectional association between GERD and OSA (odds ratio [OR] = 1.53, P = 0.0001). Subgroup analyses redemonstrated an OSA-GERD association irrespective of the tools used for diagnosing either GERD or OSA (P = 0.24 and P = 0.82, respectively). Sensitivity analyses demonstrated the same association after controlling for gender (OR = 1.63), BMI (OR = 1.81), smoking (OR = 1.45), and alcohol consumption (OR = 1.79). In patients with OSA, there were no statistically significant differences between patients with or without GERD in terms of apnea hypopnea index (P = 0.30), sleep efficiency (P = 0.67), oxygen desaturation index (P = 0.39), and Epworth Sleepiness Scale (P = 0.07).
CONCLUSION
There exists an association between OSA and GERD that is independent of the modalities used for screening or diagnosing both disorders. However, the presence of GERD did not affect the severity of OSA.
Topics: Humans; Sleepiness; Sleep Apnea, Obstructive; Gastroesophageal Reflux; Polysomnography; Alcohol Drinking
PubMed: 37300443
DOI: 10.1111/jgh.16245 -
BMC Public Health Aug 2023Insomnia disorder is a highly prevalent, significant public health concern associated with substantial and growing health burden. There are limited real-world data...
BACKGROUND
Insomnia disorder is a highly prevalent, significant public health concern associated with substantial and growing health burden. There are limited real-world data assessing the burden of insomnia disorder on daytime functioning and its association with comorbidities. The objective of this study was to leverage large-scale, real-world data to assess the burden of untreated insomnia disorder in terms of daytime impairment and clinical outcomes.
METHODS
This United States medical claims database study compares patients diagnosed with insomnia disorder but not receiving treatment ('untreated insomnia' cohort) to patients without an insomnia disorder diagnosis and without treatment ('non-insomnia' cohort). International Classification of Disease, Tenth Revision codes were used as a proxy to represent the three symptom domains (Sleepiness, Alert/Cognition, Mood) of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a newly developed and validated tool used in clinical studies to assess daytime functioning in insomnia disorder. Chronic Fatigue (R53.83) and Other Fatigue (R53.83), Somnolence (R40.0) and Disorientation (R41.0) were selected as categories representing one or more IDSIQ domains. Clinical outcomes included cardiovascular events, psychiatric disorders, cognitive impairment and metabolic disorders.
RESULTS
Approximately 1 million patients were included (untreated insomnia: n = 139,959; non-insomnia: n = 836,975). Compared with the 'non-insomnia' cohort, the 'untreated insomnia' cohort was more likely to experience daytime impairments, with mean differences in occurrences per 100 patient-years for: (a) fatigue, at 27.35 (95% confidence interval [CI] 26.81, 27.77, p < 0.01); (b) dizziness, at 4.66 (95% CI 4.40, 4.90, p < 0.01); (c) somnolence, at 4.18 (95% CI 3.94, 4.43, p < 0.01); and (d) disorientation, at 0.92 (95% CI 0.77, 1.06, p < 0.01). During the 1-year look-back period, patients in the 'untreated insomnia' cohort were also more likely to have been diagnosed with arterial hypertension (40.9% vs. 26.3%), psychiatric comorbidities (40.1% vs. 13.2%), anxiety (29.2% vs. 8.5%), depression (26.1% vs. 8.1%) or obesity (21.3% vs. 11.1%) compared with those in the 'non-insomnia' cohort.
CONCLUSIONS
This large-scale study confirms the substantial burden of insomnia disorder on patients in a real-world setting, with significant daytime impairment and numerous comorbidities. This reinforces the need for timely insomnia disorder diagnosis and treatments that improve both sleep, as well as daytime functioning.
Topics: Humans; Adult; Sleep Initiation and Maintenance Disorders; Sleepiness; Cohort Studies; Wakefulness; Sleep
PubMed: 37537544
DOI: 10.1186/s12889-023-16329-9 -
BMC Public Health Feb 2024Low-quality sleep and obstructive sleep apnea (OSA) can result in series of chronic diseases. Healthy diet has been considered as an effective and simple strategy to...
BACKGROUND
Low-quality sleep and obstructive sleep apnea (OSA) can result in series of chronic diseases. Healthy diet has been considered as an effective and simple strategy to optimize sleep quality. However, current evidence on the correlation of dietary composite antioxidant intake with sleep health remained obscure.
AIM OF THE STUDY
To determine the relationship of composite dietary antioxidant index (CDAI) and sleep health.
METHODS
Cross-sectional analyses were based on National Health and Nutrition Examination Survey (NHANES) 2005-2008. Dietary consumption was assessed by trained staff using 24-h diet recall method and CDAI was calculated based on previous validated approach that included six antioxidants. Sleep-related outcomes were self-reported by a set of questionnaires and classified into OSA, day sleepiness, and insufficient sleep. Weighted logistic regression was conducted to calculate odds ratios (ORs) and 95% confidence intervals (CIs). Restricted cubic spline (RCS) regressions were also used to evaluate the dose-response of CDAI and three sleep-related outcomes.
RESULTS
A total of 7274 subjects included (mean age: 46.97 years) were enrolled in our study, including 3658 were females (52.54%) and 3616 were males (47.46%). Of them, 70.6%, 29.51%, and 35.57% of the subjects reported that they had OSA, day sleepiness and insufficient sleep, respectively. Logistic regression showed the highest quartile of CDAI was inversely associated with the risk of OSA (OR: 0.69, 95%CI: 0.49-0.97), day sleepiness (OR: 0.64, 95%CI: 0.44-0.94) and insufficient sleep (OR: 0.68, 95%CI: 0.50-0.92) compared with the lowest quartile. RCS showed linear relationship of CDAI and insufficient sleep but non-linear relationship of CDAI with OSA and day sleepiness.
CONCLUSIONS
Our results show that CDAI was non-linearly associated with lower risk of OSA and day sleepiness whereas a linear inverse association between CDAI and insufficient sleep was observed. These findings implicate that combined intake of antioxidants could be a promising and effective approach to optimize sleep quality for public.
Topics: Male; Female; Humans; Middle Aged; Antioxidants; Cross-Sectional Studies; Nutrition Surveys; Sleep Deprivation; Sleepiness; Sleep; Sleep Apnea, Obstructive; Diet
PubMed: 38408934
DOI: 10.1186/s12889-024-18047-2