Improvement In Subjective Sleep Quality Research Articles

Effects of a daylight intervention in the morning on circadian rhythms and sleep in geriatric patients: a randomized crossover trial.

During hospitalization, circadian rhythms and sleep are often disrupted, which has negative effects on health outcomes. Therefore, we aimed to investigate whether a daylight intervention in the morning could improve the circadian rhythms of cortisol and melatonin and enhance objective and subjective sleep quality in geriatric patients. The present study is a randomized, two-period crossover trial conducted in a geriatric ward in 15 non-demented geriatric trauma patients with a mean age of 83.1 ± 5.4years. All patients underwent a daylight intervention period, during which they were exposed to a daylight lamp from 8:00 to 13:00h, and a control period of 6days each. Cortisol and melatonin levels were measured on day 5 of each period. Objective and subjective sleep quality were assessed using actigraphy and questionnaires, respectively. Within-participant differences between periods were investigated for all parameters. A trend towards improvement in cortisol and melatonin rhythmicity was found. An increase in mean melatonin levels from 0.3 ± 0.1 to 0.9 ± 0.8ng/L was observed during the intervention period (p = .063). There was also a trend towards increased sleep efficiency, whereas subjective sleep quality tended to decrease. None of the results were significant. A daylight intervention in the morning led to a positive trend in cortisol and melatonin rhythmicity, whereas no improvement in subjective sleep quality was found. DRKS00028626 at German Clinical Trials Register, 13.06.2022.

THE EFFECT OF PEER EDUCATION ON SLEEP HYGIENE ON SLEEP QUALITY AND PSYCHOLOGICAL RESILIENCE IN UNIVERSITY STUDENTS LIVING IN DORMITORIES

This study was conducted to examine the effect of peer education on sleep hygiene sleep quality and psychological resilience in university students living in dormitories. In the study, a quasi-experimental method with a pretest-posttest control group was used. 240 university students staying at Akyazı Credit and Dormitories Institution in Akyazı district of Sakarya province participated in the study. Half of the students (n=120) formed the intervention group and the other half (n=120) formed the control group. Before the study, 20 students were given sleep hygiene training by the research team. The training group provided peer education to the intervention group on sleep hygiene. No intervention was made in the control group. Student diagnostic form, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, and Brief Psychological Resilience Scale were used as data collection tools. There was no statistically significant difference between the Sleep Hygiene Index and Brief Psychological Resilience Scale score averages of the intervention and control group students included in the study at the beginning and the last interview (p>0.05). However, it was determined that there was an improvement in the sleep hygiene and psychological resilience levels of the students in the intervention group (p0.05). In addition, it was determined that the intervention group had a significant improvement in subjective sleep quality and sleep latency, which are sub-dimensions of the Pittsburgh Sleep Quality Index (p

The impact of exercise interventions on sleep in adult populations with depression, anxiety, or posttraumatic stress: review of the current evidence and future directions.

Consistent evidence suggests that exercise leads to improvements in subjective sleep quality and also objective sleep metrics in non-psychiatric adult populations. However, the degree to which exercise provides sleep benefits for adults with psychiatric disorders is less known, despite the potential benefits given that sleep disturbance is prevalent in these populations. In this narrative review, we synthesize results of randomized controlled trials examining the influence of aerobic and/or resistance exercise interventions on sleep outcomes in adult psychiatric populations. We specifically focus on populations with elevated symptoms or diagnoses of depression, anxiety, or posttraumatic stress disorder. A systematic search through June 2024 yielded 26 relevant trials. Overall, most trials reported improvement of subjective sleep quality after aerobic and/or resistance exercise programs in samples with depression. Similar effects were observed for posttraumatic stress; however, larger trials are needed. Further research is needed to examine the impact of exercise on sleep in anxiety populations as only one trial with mixed results was identified. Results were more equivocal for the subpopulation of adult women with perinatal or postpartum depression, demonstrating the importance of understanding exercise effects on sleep in specific subpopulations. Few studies examined objective sleep outcomes, impact of acute exercise on next day sleep, or the interplay between exercise, sleep, and psychiatric symptom changes, all important areas of future research. Other implications and future directions are discussed, including potential moderators and mechanisms of action that warrant further study to better understand how exercise interventions may optimally target sleep in psychiatric populations.

Use of mHealth Technologies to Increase Sleep Quality among Older Adults: A Scoping Review.

Sleep disorders increase with age and are known risk factors for several mental and physical diseases. They also significantly contribute to a lower quality of life. Nonpharmaceutical approaches, such as cognitive behavioral therapy for insomnia, sleep hygiene advice, relaxation exercises, and physical activity programs, can be delivered directly to patients via mHealth technologies, thereby increasing the accessibility of such interventions and reducing health care-related costs. This scoping review aims to evaluate the effectiveness of mHealth interventions for improving sleep quality among older adults. Published studies in the last 10 years (2013-2023) were identified by searching electronic medical databases (PubMed, PsycINFO, CINAHL, and Scopus) in July 2023 and were independently reviewed by two different authors. The analysis of the data was performed in 2023. The research retrieved 693 records; after duplicates were removed, 524 articles were screened based on their title and abstract, and 28 of them were assessed in full text. A total of 23 studies were excluded because they did not meet the inclusion criteria in terms of population age (60 years or over) or type of intervention (mHealth-based) or because they addressed secondary insomnia. A total of five studies were included in this review, and all of them reported improvements in subjective sleep quality after the application of the mHealth interventions. Two studies also conducted objective assessments of sleep outcomes using actigraphy, reporting improvements only in some of the variables considered. Despite the limited number of available studies, these results are promising and encourage further research.

Matcha Does Not Affect Electroencephalography during Sleep but May Enhance Mental Well-Being: A Randomized Placebo-Controlled Clinical Trial.

Although theanine in matcha improves sleep quality and cognitive function, the caffeine in green tea is thought to worsen sleep quality. Therefore, this study investigated the factors behind the observed improvements in subjective sleep quality in matcha. A placebo-controlled randomized double-blind parallel-group study was conducted on healthy Japanese men and women aged 27-64 years. After 4 weeks of consuming 2.7 g of matcha daily (containing 50.3 mg theanine, 301.4 mg catechins, and 71.5 mg caffeine), no significant differences were observed between the control and matcha groups on total sleep time, sleep latency, wake after sleep onset, or sleep efficiency measured by electroencephalography (EEG). However, the sleep questionnaire Oguri-Shirakawa-Azumi Sleep Inventory, the Middle-age and Aged version (OSA-MA), administered immediately after waking showed a trend toward increased satisfaction with sleep time (p < 0.1), and EEG measurements indicated significantly shortened wake-up times after waking with matcha intake (p < 0.05). The Beck Depression Inventory-II scores also tended to decrease (p < 0.1). The continuous intake of matcha may offer improved subjective sleep quality and emotional stability despite not offering significant changes in objective sleep parameters.

The effects of time-restricted eating on sleep in adults: a systematic review of randomized controlled trials.

Time-restricted eating (TRE), a dietary pattern reducing the duration of daily food consumption, has recently gained popularity. Existing studies show the potential benefits of TRE for cardiometabolic health. Uncertainty remains about whether these benefits are solely from altered meal timing or influences on other health behaviors, including sleep. Despite growing scientific interest in the effects of TRE on sleep parameters, the topic has not been systematically explored. This review examined the effects of TRE interventions (daily fasting duration ≥14 h) lasting at least 8 weeks on objective and subjective sleep parameters. Six randomized control trials were identified through Pubmed, Embase, Google Scholar, and Scopus through September 2023. Of the included studies, three employed objective sleep measures using wearables and five studies assessed sleep subjectively through self-report questionnaires. Only one study reported significant improvements in subjective sleep quality following a TRE intervention. Additionally, one study found significant decreases in sleep duration, two studies found significant decreases in sleep efficiency, and one found significant increases in sleep onset latency. Current evidence indicates that short to mid-term TRE does not typically worsen sleep parameters. However, some populations may experience reduced sleep disturbances, while others may experience reductions in sleep efficiency. Longer duration studies with objective sleep assessments are needed to better understand the effects of TRE on sleep parameters.

Yoga Exercises as a Therapeutic Approach for Adults with Insomnia to Promote better Sleep: A Randomized Control Trial

Background: Insomnia is a prevalent sleep disorder that significantly impacts the quality of life and is associated with various health complications, including high blood pressure, heart disease, diabetes, anxiety, and depression. Traditional treatments for insomnia often involve pharmacological interventions, but there is growing interest in alternative therapies such as yoga. This study investigates the efficacy of yoga as a therapeutic approach to improving sleep quality in adults with insomnia. Objective: The objective of this study was to evaluate the effects of a structured yoga program on sleep quality and sleep latency in adults diagnosed with insomnia. Methods: The study employed a cross-sectional design conducted at multiple healthcare facilities, including the Physiotherapy Outpatient Department at Holy Family Hospital, Benazir Bhutto Hospital, and District Headquarters Hospital in Rawalpindi. The study duration was four months, involving 54 participants selected through random sampling techniques. Inclusion criteria included adults aged 18 to 65 years diagnosed with insomnia according to the International Classification of Sleep Disorders (ICSD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM). Exclusion criteria included severe medical or psychiatric disorders, substance abuse, pregnancy, or recent changes in sleep medication. Participants in the intervention group engaged in a standardized yoga program consisting of gentle yoga postures, controlled breathing techniques, and mindfulness meditation, conducted twice weekly for eight weeks, with each session lasting 60 minutes. The control group received standard care for insomnia. Data collection involved subjective assessments of sleep quality using validated questionnaires and objective measures through polysomnography. Statistical analysis was performed using SPSS version 25.0, with independent sample t-tests comparing means between groups and repeated measures ANOVA for within-group analysis. Results: The yoga group showed significant improvements in subjective sleep quality and sleep latency. The mean sleep quality score improved from 2.18 ± 0.66 pre-intervention to 0.92 ± 0.37 post-intervention (p=0.0001), while the control group showed a less marked improvement from 2.37 ± 0.48 to 2.03 ± 0.18 (p=0.0012). Sleep latency in the yoga group decreased from 3.00 ± 0.00 to 1.29 ± 0.40 (p=0.0002), whereas the control group showed a reduction from 2.44 ± 0.49 to 2.11 ± 0.31 (p=0.0013). ANOVA results confirmed the statistical significance of these findings, with an F-value of 69.897 for sleep quality (p=0.0001) and 361.947 for sleep latency (p=0.0002). Conclusion: The findings indicate that a structured yoga program significantly improves sleep quality and reduces sleep latency in adults with insomnia. Yoga appears to be an effective non-pharmacological intervention for managing insomnia, offering a viable alternative to traditional treatments.

Sleep architecture disturbance due to the use of benzodiazepines

Introduction Insomnia, which is characterized by difficulty in initiating or maintaining a physiological sleep, is a relevant clinical issue, affecting not only the elderly population (from 20% to 40%), but also the general population since 30% of adults report problems in sleeping properly. In addition, 30-40% of adults report complaints about sleep quality lifetime, and10-15% report chronic insomniaBenzodiazepines (BZDs) are commonly prescribed to treat insomnia and sleep disorders. BZDs show a rapid sedative and anxiolytic effect, successfully used in the acute treatment of insomnia as well as anxiety, agitation, or anxiety associated with any type of psychiatric disorder. Their use is associated with potential side effects such as residual daytime sleepiness, ataxia, and dizziness. Long-term BZDs use may lead to drug abuse, tolerance, drug dependency, and abstinence. For instance, BZDs abrupt withdrawal can lead to severe symptoms such as insomnia and/or rebound anxiety, an increase in heart rate and blood pressure, nausea and/or vomiting, sweating, diarrhea, convulsions, and other neurological and psychiatric symptoms.ObjectivesThis e-poster aimed to summarize evidence regarding the effect of BZDs treatment on human Sleep Architecture.MethodsA bibliopgraphical review was performed using PubMed platform. All relevant articles were found using the keywords: benzodiazepines, sleep architecture, insomnia.ResultsProlonged use of benzodiazepines leads to an increase of time spent in stages 2 and a decrease of time in stages 1, 3, and 4. The increased NREM stage 2 is associated with a subjective improvement in sleep quality. The decrease in NREM sleep time in stages 3 and 4 is usually associated with lesser “rest” for the brain, which leads to a lack of concentration.ConclusionsBZDs use modified sleep architecture in the short and long term.Disclosure of InterestNone Declared

Efficacy of a fish hydrolysate supplement on sleep quality: A randomized, double-blind, placebo-controlled, crossover clinical trial

Background & AimsSleep disturbances are widespread in modern societies and linked to a variety of diseases, creating an urgent need for the development of products that help combat sleep difficulties. One suitable nutritional supplement may be a fish hydrolysate composed of low molecular weight peptides. MethodsThis two-arm, double-blind, randomized, placebo-controlled crossover study investigated the effect of a 4-week fish hydrolysate intervention on sleep in a healthy German population reporting poor sleep quality, assessed with the Pittsburgh Sleep Quality Index (PSQI). Further sleep parameters were measured using an online diary and a wrist wearable device. Additionally, questionnaires related to stress, anxiety, depression, and well-being were evaluated and salivary cortisol and product satisfaction were assessed. ResultsThe 4-week fish hydrolysate supplementation significantly improved subjective sleep quality measured with the PSQI-score (p = .002). Moreover, individuals reported improvements in sleep efficacy and a reduction in sleep disturbances and daytime sleepiness during fish hydrolysate intake (p = .013, p = .046, p = .004 respectively), but not during placebo phase (all p > .05). No significant intra-individual differences were found between fish hydrolysate and placebo supplementation (p > .05). ConclusionsAlthough no significant intra-individual differences were found between fish hydrolysate and placebo supplementation, the significant improvement in subjective sleep quality from baseline to treatment phase suggests that fish hydrolysate is a safe nutritional supplement to support individuals with self-reported sleep problems. Clinical trial registrationThe study is registered at ClinicalTrials.gov with the Identifier NCT04983355.

Novel Multi-Strain E3 Probiotic Formulation Improved Mental Health Symptoms and Sleep Quality in Hong Kong Chinese.

Mental health issues have emerged as a significant concern in public health, given their association with physical and psychological comorbidities and the resultant socioeconomic burdens. Recent studies have highlighted the interplay between gut microbes and brain functions through the gut-brain axis. To investigate this further, we conducted a targeted 16S rRNA sequencing and comprehensive bioinformatic analysis among Southern Chinese individuals to explore the role of the gut microbiome in depression, anxiety, and sleep disturbance. We analyzed the differences in the gut microbiome profile of 68 participants with sleep disturbance and mood symptoms before and after an 8-week course of a novel oral E3 multi-strain probiotics formula. The results revealed a significant improvement in subjective sleep quality (PSQI: mean 8.79 at baseline vs. 7.10 at week 8, p < 0.001), depressive symptoms (PHQ9: mean 6.17 at baseline vs. 4.76 at week 8, p < 0.001), and anxious symptoms (GAD7: mean 4.90 at baseline vs. 3.76 at week 8, p < 0.001). Additionally, there were notable differences in beta diversity (weighted UniFrac; p = 0.045) and increased Firmicutes/Bacteroidetes (F/B) ratio (p = 4 × 10-4) were observed in the gut microbiome analysis. Furthermore, the relative abundance of Bifidobacterium bifidum (p < 0.001), Lactobacillus acidophilus (p < 0.001), Lactobacillus helveticus (p < 0.001) and Lactobacillus plantarum (p < 0.001) were significantly increased after the 8-week probiotic supplementation. Our study suggests that the gut microbial landscape varies between responders and non-responders at multiple levels, including genera, species, functional, and network interaction. Notably, the use of probiotics in populations with depressive or anxious symptoms and poor sleeping quality remodeled the gut microbiome and demonstrated improved mood and sleep quality.

Effectiveness of Aerobic Exercise and Tai Chi Interventions on Sleep Quality in Patients With Advanced Lung Cancer

Sleep disturbances prevalent among patients with advanced lung cancer can aggravate physical and psychological symptoms, contributing to decreased quality of life and survival. To compare the effectiveness of 2 physical activities of different modalities and intensities, namely aerobic exercise (AE) and tai chi (TC), on subjective sleep quality, physical and psychological outcomes, and survival in patients with advanced lung cancer. This assessor-blinded, randomized clinical trial was conducted in 3 public hospitals in Hong Kong between December 19, 2018, and September 7, 2022. A total of 226 patients with advanced lung cancer were recruited and randomized 1:1:1 to AE, TC, or the control group. For 16 weeks, the AE group received two 60-minute supervised group exercise sessions and home-based exercises per month, and the TC group received 60-minute group sessions twice weekly. The control group received physical activity guidelines. The primary outcome was subjective sleep quality. Secondary outcomes included objective sleep measures, anxiety, depression, fatigue, quality of life, physical function, circadian rhythm, and 1-year survival. Assessments were conducted at baseline, 16 weeks (T1), and 1 year (T2). The 226 participants had a mean (SD) age of 61.41 (8.73) years, and 122 (54.0%) were female. Compared with the control group, participants in the AE and TC groups showed statistically significant improvements in subjective sleep quality from baseline to T1 (AE: between-group difference, -2.72; 95% CI, -3.97 to -1.46; P < .001; TC: between-group difference, -4.21; 95% CI, -5.48 to -2.94; P < .001) and T2 (AE: between-group difference, -1.75; 95% CI, -3.24 to -0.26; P = .02; TC: between-group difference, -3.95; 95% CI, -5.41 to -2.49; P < .001), psychological distress, physical function, step count, and circadian rhythm. The TC group had a statistically significant greater improvement in sleep than the AE group at T1 (between-group difference, -1.49; 95% CI, -2.77 to -0.22; P = .02) and T2 (between-group difference, -2.20; 95% CI, -3.57 to -0.83; P < .001). Participants in the TC group showed statistically significant improvement in survival compared with the control group. In this randomized clinical trial, AE and TC improved sleep, psychological distress, physical function, and circadian rhythm, with TC demonstrating greater benefits on sleep and survival. Both exercises, but particularly TC, can be incorporated into lung cancer survivorship care. ClinicalTrials.gov Identifier: NCT04119778.

The impact of mindfulness training on posttraumatic stress disorder symptoms, subjective sleep quality, and objective sleep outcomes in police officers.

Sleep disturbances cooccur with posttraumatic stress disorder (PTSD) and are often correlated with PTSD severity. Previous research has shown that sleep problems mediate the relationship between PTSD and negative physical and mental health outcomes but has relied on self-reported sleep quality. We tested the effects of mindfulness training-previously shown to improve sleep quality and reduce PTSD symptoms-on subjective and objective sleep metrics and relationships with reduced PTSD symptoms. Following baseline data collection in 114 law enforcement officers, we randomly assigned participants to either an 8-week mindfulness training group or a waitlist control group. We repeated assessments immediately posttraining and at 3-month follow-up. Self-reported PTSD symptoms and subjective sleep quality were measured at each visit with the PTSD checklist and Pittsburgh Sleep Quality Index (PSQI), respectively. Participants also wore a Fitbit Charge 2 continuously over the course of a 4- to 6-day work week following each visit, from which we extracted two distinct objective sleep metrics: total minutes of sleep and sleep efficiency. At baseline, PTSD symptoms were correlated with PSQI scores but not objective Fitbit metrics. Relative to waitlist, mindfulness training led to improved subjective sleep quality and reduced PTSD symptoms. Reduced PTSD symptoms mediated the improvement in subjective sleep quality following mindfulness training. Neither objective sleep metric demonstrated improvements following mindfulness training, nor did these metrics mediate reduced PTSD symptoms. This study provides evidence linking improved subjective sleep quality, but not objective sleep markers, to reductions in PTSD symptoms following mindfulness training. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Orofacial myofunctional reeducation assisted by a prefabricated reeducation appliance: a systematic review of the literature

Several cross-sectional studies have shown the association of a dysfunctional orofacial environment with a greater prevalence of malocclusions. Orofacial myofunctional reeducation (OFMR) is the rehabilitation of the muscles, functions and resting postures of the orofacial complex. It is used in the therapeutic management of orofacial dysfunction in patients of all ages and with a wide range of disorders and comorbidities. RMOF mainly uses isotonic and isometric exercises targeting the oral and oropharyngeal structures, combined with specific exercises for ventilation, swallowing and mastication. It may involve the use of prefabricated reeducation appliances (PRAs), which may also be prescribed to modify the shape and relationship of the dental arches. The primary objective of this systematic review of the literature was to describe and evaluate the efficacy of prefabricated reeducation appliance-assisted OFMR in orthodontics, occlusodontics and dental sleep medicine. Its secondary objective was to assess whether the use of currently available PRAs is associated with adverse effects. The systematic literature review was undertaken using five electronic databases: Medline (via PubMed), Web of Science, Cochrane Library, Embase, and Google Scholar, to identify studies evaluating the efficacy of PRA-assisted OFMR in the treatment of orofacial dysfunctions and parafunctions, temporo-mandibular dysfunction (TMD) or obstructive sleep apnea (OSA) in children, adolescents and adults, published until 20 March 2023. The primary outcome of interest was the therapeutic efficacy of PRA-assisted OFMR. In patients with obstructive sleep apnoea (OSA), efficacy was assessed primarily by a decrease in the apnoea/hypopnoea index (AHI) of at least five episodes per hour from baseline, improvement in subjective sleep quality, sleep quality measured by nocturnal polysomnography and subjectively measured quality of life. In patients with orofacial dysfunctions, parafunctions or TMD, efficacy was assessed mainly by electromyography (EMG), history and clinical examination. Secondary outcomes were dentoalveolar or skeletal improvements, and possible adverse effects of the PRAs used, including adverse effects on occlusion. Only fourteen studies met all inclusion criteria: two randomised controlled trials, one non-randomised controlled trial, five prospective case-control studies, two retrospective case-control studies, two prospective case series and two retrospective case series. The two randomised controlled trials were assessed as "low risk of bias" according to the Cochrane Back Review Group's 12 risk of bias criteria. The methodological quality of the remaining 12 included studies was assessed using the ROBINS-I tool, according to the recommendations of the Cochrane Handbook. One was judged to have a measured risk of bias, eight a significant risk of bias and three a critical risk of bias. Based on the available evidence, PRA-assisted OFMR results in a statistically significant (p=0.0425) reduction in AHI in children with mild to moderate obstructive sleep apnea. In children with obstructive sleep apnoea undergoing adenoid and/or tonsil surgery, postoperative OFMR combined with a flexible PRA leads to a greater reduction in AHI compared to a control group and an improvement in SaO2 at 6 months and 12 months after surgery (p<0.01). It also contributes to greater improvement in sleep disturbance, physical fitness, daytime lethargy in the treated group than in the control group 6 months and 12 months after surgery (p<0.05). PRA-assisted OFMR provides correction of atypical swallowing and improvement in orofacial muscle balance. GRPs are generally less effective than activators for the treatment of Class II Division 1 malocclusions and appear to cause more adverse effects, mainly vestibuloversion of the mandibular incisors. The use of PRA-assisted OFMR for the management of TMD is not validated by current evidence. Published data, albeit of uneven methodological quality, appear to show the superiority of OFMR combined with the use of a PRA, compared with the implementation of OFMR without PRA. Prospective studies with large sample sizes would be useful to better evaluate the new therapeutic possibilities brought by the combination of OFMR with a PRA. Continued attention should be paid to the monitoring of possible adverse effects of PRA-assisted OFMR on the dental arches, especially the vestibuloversion of the mandibular incisors. It might be useful to reflect on the relevance of the arguments put forward by manufacturers about the particularities of their devices and their supposed effects. PRA-assisted OFMR appears to be a necessary paradigm shift, which it seems useful to bring to our patients. This protocol was registered on March 02, 2023 in the International Prospective Register of Systematic Review (PROSPERO) and received the CRD number: CRD42023400421.

Effect of massage therapy on sleep quality in critically ill patients: A systematic review and meta-analysis.

The aim of the study was to compare the effects of massage interventions on sleep quality among patients in the adult critical care unit. Massage interventions have positive effects when applied to manage sleep quality in critical care units. However, research identifying the effect of massage intervention is limited. This study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Five databases were searched from their inception to 15 April 2022 (the last search was conducted on 15 November 2022, but it yielded no additional eligible studies). The literature search was conducted using Embase, MEDLINE, the Cochrane Library, CINAHL, PsycINFO and additional sources such as Google Scholar. The Cochrane risk of bias tool for randomised trials (RoB 2.0) was used to assess the risk of bias. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system assessed the certainty of evidence and recommendations. In total, ten randomised controlled trials comprising 569 participants were used in the systematic review, and eight trials were included in the meta-analysis. Subgroup analysis revealed significant effects of foot reflexology massage on subjective sleep quality. Massage therapy for a two-night duration in cardiac care unit patients exhibited a significant effect on subjective sleep quality. The overall GRADE certainty of evidence was low. Massage intervention, particularly foot reflexology massage, with a two-night duration showed improvement in subjective sleep quality among critically ill patients. Although evidence quality was low, the results suggest that massage interventions provide a non-invasive, low-cost and effective way to promote sleep quality in critically ill adult patients. Massage interventions can enable nurses to recommend and implement strategies promoting and improving sleep quality among critically ill patients. The review protocol was registered a priori and published online in the PROSPERO database of systematic reviews (www.crd.York.ac.uk/Prospero with the registration number # CRD42022332371). No patient or public contribution if such details are not necessary or do not apply to your work and state why.

The Virtual Sleep Lab—A Novel Method for Accurate Four-Class Sleep Staging Using Heart-Rate Variability from Low-Cost Wearables

Sleep staging based on polysomnography (PSG) performed by human experts is the de facto "gold standard" for the objective measurement of sleep. PSG and manual sleep staging is, however, personnel-intensive and time-consuming and it is thus impractical to monitor a person's sleep architecture over extended periods. Here, we present a novel, low-cost, automatized, deep learning alternative to PSG sleep staging that provides a reliable epoch-by-epoch four-class sleep staging approach (Wake, Light [N1 + N2], Deep, REM) based solely on inter-beat-interval (IBI) data. Having trained a multi-resolution convolutional neural network (MCNN) on the IBIs of 8898 full-night manually sleep-staged recordings, we tested the MCNN on sleep classification using the IBIs of two low-cost (<EUR 100) consumer wearables: an optical heart rate sensor (VS) and a breast belt (H10), both produced by POLAR®. The overall classification accuracy reached levels comparable to expert inter-rater reliability for both devices (VS: 81%, κ = 0.69; H10: 80.3%, κ = 0.69). In addition, we used the H10 and recorded daily ECG data from 49 participants with sleep complaints over the course of a digital CBT-I-based sleep training program implemented in the App NUKKUAA™. As proof of principle, we classified the IBIs extracted from H10 using the MCNN over the course of the training program and captured sleep-related changes. At the end of the program, participants reported significant improvements in subjective sleep quality and sleep onset latency. Similarly, objective sleep onset latency showed a trend toward improvement. Weekly sleep onset latency, wake time during sleep, and total sleep time also correlated significantly with the subjective reports. The combination of state-of-the-art machine learning with suitable wearables allows continuous and accurate monitoring of sleep in naturalistic settings with profound implications for answering basic and clinical research questions.

The role of flumazenil in generalised anxiety disorder: a pilot naturalistic open-label study with a focus on treatment resistance

Anxiety disorders are highly prevalent and chronic disorders with treatment resistance to current pharmacotherapies occurring in approximately one in three patients. It has been postulated that flumazenil (FMZ) is efficacious in the management of anxiety disorders via the removal of α4β2δ gamma-aminobutyric acid A receptors. To assess the safety and feasibility of continuous low-dose FMZ infusions for the management of generalised anxiety disorder (GAD) and collect preliminary efficacy data. Uncontrolled, open-label pilot study. Participants had a primary diagnosis of generalised anxiety disorder (GAD) and received two consecutive subcutaneous continuous low-dose FMZ infusions. Each infusion contained 16 mg of FMZ and was delivered over 96 ± 19.2 h. The total dose of FMZ delivered was 32 mg over approximately 8 days. Sodium valproate was given to participants at risk of seizure. The primary outcome was the change in stress and anxiety subscale scores on the Depression Anxiety Stress Scale-21 between baseline, day 8, and day 28. Nine participants with a primary diagnosis of GAD were treated with subcutaneous continuous low-dose FMZ infusions; seven participants met the criteria for treatment resistance. There was a significant decrease in anxiety and stress between baseline and day 8 and baseline and day 28. There was also a significant improvement in subjective sleep quality from baseline to day 28 measured by the Jenkins Sleep Scale. No serious adverse events occurred. This study presents preliminary results for subcutaneous continuous low-dose FMZ's effectiveness and safety in GAD. The findings suggest that it is a safe, well-tolerated, and feasible treatment option in this group of patients. Future randomised control trials are needed in this field to determine the efficacy of this treatment.

Exercise Training Program Improves Subjective Sleep Quality and Physical Fitness in Severely Obese Bad Sleepers.

Sleep quality is an important modulator of neuroendocrine function, as sleep problems are related to metabolic and endocrine alterations. The main objective was to determine the effects of an exercise training program on the sleep quality of severely obese patients with sleep problems. The secondary objective was to determine the relationship between fitness and anthropometric parameters with sleep quality scores. Thirty severely obese patients participated in 16 weeks of PA intervention (age: 39.30 ± 11.62 y, BMI: 42.75 ± 5.27 kg/m2). Subjective sleep quality, anthropometric parameters, and fitness (i.e., handgrip strength and cardiorespiratory fitness) were measured. Two groups were defined as good sleepers (n = 15, 38.06 ± 12.26, men = 1) and bad sleepers (n = 15, 40.53 ± 11.23, men = 3). The good sleeper group reported improvement in cardiorespiratory fitness (61.33 ± 68.75 m vs. 635.33 ± 98.91 m, p = 0.003) and handgrip strength (29.63 ± 9.29 kg vs. 31.86 ± 7.17 kg, p = 0.049). The bad sleeper group improved their cardiorespiratory fitness (472.66 ± 99.7 m vs. 611.33 ± 148.75 m, p = 0.001). In terms of sleep quality dimensions, the bad sleeper group improved their subjective sleep quality (p < 0.001), sleep latency (p = 0.045), sleep duration (p = 0.031), and habitual sleep efficiency (p = 0.015). Comparing the changes in both groups (∆), there were differences in subjective sleep quality scores (∆ = 2.23 vs. ∆ = -3.90, p = 0.002), where 86.6% of the bad sleeper group improved sleep quality (p = 0.030). An increase in handgrip strength was correlated to improving sleep quality scores (r = -0.49, p = 0.050). Severely obese bad sleepers improved their subjective sleep quality, the components of sleep, and cardiorespiratory fitness through an exercise training program. Improvement in subjective sleep quality was linked to an increase in handgrip strength.

Dark nighttime interventions and sleep quality in intensive care unit patients: A systematic review and meta‐analysis

AbstractBackgroundSleep disturbances resulting from adverse clinical and environmental conditions are associated with unfavourable outcomes in critically ill patients.AimTo collect evidence on the effect of dark nighttime interventions on sleep quality and daytime sleepiness in intensive care unit (ICU) patients.Study DesignThe study followed the Preferred Reporting Items for Systematic reviews and Meta‐Analyses recommendations. This is a systematic review and meta‐analysis of experimental and quasi‐experimental studies, developed with adult patients admitted to ICUs and submitted to measures such as environmental brightness reduction, eye mask or blue light‐blocking glass use at night. Outcomes were subjective or objective sleep quality and excessive daytime sleepiness. Search was carried out in the PubMed/MEDLINE, Cochrane Library, Embase, Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Scopus databases, using grey literature. Covidence software, Cochrane tools and Grading of Recommendations Assessment, Development and Evaluation were used, and a meta‐analysis was performed using RevMan software.ResultsThirteen articles were included in the systematic review and seven studies were included in the meta‐analysis. There were 3 trials with 175 participants regarding lighting reduction and environmental noise control versus the usual routine, 2 of these trials, with 96 patients, were compiled in meta‐analysis in which it was observed a significant statistical improvement in subjective sleep quality, mean difference (MD) of 11.89 points (0–100); 95% confidence interval (CI) 8.0–15.76, evidence set with moderate certainty, as well as this same intervention, reduced daytime sleepiness in 2 trials, 135 participants (standardized MD −0.63; 95% CI −0.98 to −0.28), with low certainty evidence. Eye masks versus usual routine, 2 trials, 126 participants, improved subjective sleep quality (MD of 10 points; 95% CI 7.97–12.03), with moderate certainty of evidence. Eye mask use combined with other therapies versus usual routine, 5 trials, 204 participants, improved subjective sleep quality in all studies, with low certainty of evidence. Objective sleep assessment was not improved with these interventions.ConclusionsThis review shows some benefits of nighttime interventions on subjective sleep quality and excessive sleepiness, however, there is an urgent need to conduct better and more robust studies in this field.Relevance to Clinical Practiceapplying measures such as lighting reduction and eye mask use significantly improves sleep quality.

Erenumab Impact on Sleep Assessed With Questionnaires and Home-Polysomnography in Patients With Migraine: The ERESON Study.

IntroductionMigraine and sleep share a complex and unclear relationship. Poor sleep may trigger migraine attacks; migraine, in turn, is frequently associated with sleep disorders. Few previous studies used questionnaires to assess sleep changes in patients who were treated with migraine-preventive medications (MPMs). More extensive polysomnography (PSG)-based studies for this purpose were not available.ObjectiveTo investigate possible sleep changes in patients with migraine treated with erenumab, using validated sleep questionnaires and home-PSG.MethodsThis observational, prospective, open-label pilot study was conducted at the Clinical Neurology Unit Headache Center of Udine University Hospital from 2020 to 2021. Patients were treated with erenumab as monotherapy or add-on treatment for migraine prevention. Sleep changes were evaluated with questionnaires and polysomnographic recordings at baseline, after 3 and 12 months of treatment. Erenumab efficacy and safety in migraine prophylaxis were also investigated.ResultsTwenty-nine patients completed 3 months of follow-up, whereas 15 patients completed 12 months. We found a weak trend of improvement in daytime somnolence after 3 months of treatment, with stronger results after 12 months (median Epworth Sleepiness Scale (ESS) score from 6.0 to 4.0, p = 0.015); a significant improvement in subjective sleep quality (median Pittsburgh Sleep Quality Index (PSQI) total score from 7 to 5; p = 0.001) was also observed. Home-PSG showed a significant increase in objective sleep efficiency (SE), both after 3 (from 88.1 to 91.0, p = 0.006) and 12 months (from 87.1 to 91.0, p = 0.006) of treatment. In addition, our data confirmed erenumab effectiveness and safety in migraine prevention.ConclusionOur study demonstrated an improvement in both subjective and objective sleep quality in patients treated with a migraine-preventive therapy. Erenumab, in particular, does not cross the blood-brain barrier (BBB), thus a direct effect on sleep is unlikely. Future studies are needed to better understand the mutual influence between migraine and sleep disorders.

A Principal Stratification Approach to Estimating the Effect of Continuing Treatment after Observing Early Outcomes

Abstract Chronic diseases often require continuing care, and early response to treatment can be an important predictor of long-term efficacy. Often, an apparent lack of early efficacy may lead to discontinuation of treatment, with the decision made either by clinicians or by the patients themselves. Thus, it is important to determine whether or not a desired early outcome corresponds to a beneficial long-term effect of continuing treatment, and conversely, whether or not the absence of such an outcome corresponds to a lack of long-term benefit. However, primary clinical trials of such treatments are not commonly designed to answer such questions, for example by randomizing subjects to continue or discontinue treatment after observing early outcomes. We propose an approach to estimating the effect of continuing treatment after observing early outcomes using data from randomized controlled trials in which treatment discontinuation was not part of the design. Our approach estimates average causal effects of continuing treatment on long-term outcomes in principal strata defined by the potential early outcomes under treatment. For illustration, we estimate the effects of continuing to take gaboxadol to treat insomnia conditional on early improvement in subjective sleep quality after two nights, based on a standard parallel-arm randomized controlled trial.