Improvement In Subjective Sleep Quality Research Articles

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.

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.ConclusionThis 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.

The Concomitant Pattern of Association Between Subjective Global Sleep Quality and Daytime Dysfunction in Hypnotic-Treated Older Adults: The Yilan Study, Taiwan

ObjectiveThe relationship between improvements in subjective sleep quality and restoration of daytime function remains unclear. This study aimed to examine the concomitant pattern between subjective sleep quality and daytime dysfunction in hypnotic-treated older adults.MethodsThis was a community-based, cross-sectional study. Participants comprised community-dwelling adults aged ≥ 65 years. Individual items from the Pittsburgh Sleep Quality Index (PSQI) were adopted to evaluate subjective global sleep quality and daytime dysfunction. Daytime dysfunction included composite scores of daytime dysfunction in the PSQI and its two sub-components: “staying awake” and “maintaining enthusiasm.” Based on hypnotic use and status in subjective sleep quality, participants were categorized into four groups: “healthy control,” “treated with good sleep quality (T+GSQ),” “treated with poor sleep quality (T+PSQ),” and “not treated with poor sleep quality (NT+PSQ)”. The associations between these four groups and daytime dysfunction were analyzed using logistic regression.ResultsIn total, 2622 individuals participated in the study. After controlling for covariates, the T+PSQ group was more likely to have daytime dysfunction, including “composite daytime dysfunction” (OR: 6.41; 95% CI: 3.90–10.55), “poor at staying awake” (OR: 3.04; 95% CI: 1.45–6.37), and “poor at maintaining enthusiasm” (OR: 7.42; 95% CI: 4.33–12.70) compared to the T+GSQ group. However, the healthy control group was less likely than the T+GSQ group to present with daytime dysfunction, including “composite daytime dysfunction” (OR: 0.43; 95% CI: 0.26–0.72) and “poor at maintaining enthusiasm” (OR: 0.39; 95% CI: 0.22–0.68).ConclusionSubjective sleep quality attributed to hypnotic use did not necessarily indicate restoration of daytime dysfunction.

The impact of the COVID-19 lockdown on human psychology and physical activity; a space analogue research perspective

AbstractIntroductionAstronauts will encounter isolated, confined and extreme (ICE) conditions during future missions, and will have to be able to adapt. Until recently, however, few places on Earth could serve as acceptable space analogues (i.e., submarine and polar regions). The coronavirus disease-2019 (COVID-19)-related lockdowns around the globe provided a good opportunity to obtain more comprehensive datasets on the impact of prolonged isolation on human functioning in a very large sample.MethodsSeven hundred forty-eight individuals (Belgium 442, Spain 183, Germany 50, Italy 50, US 23; Mean age ± SD: 41 ± 14 years, with an age range of 18–83 years; 66% women) filled out an online survey assessing the impact of the COVID-lockdown on psychological, exercise and general health variables a first time near the beginning of the initial lockdown (hereafter ‘T1’; 24 ± 13 days after the start of the first lockdown; i.e., 3 weeks after the start of the first lockdown) and a second time a couple of weeks thereafter (hereafter ‘T2’; 17 ± 5 days after the first online survey; i.e., 6 weeks after the start of the first lockdown).ResultsFrom T1 to T2 an improvement of subjective sleep quality was observed (P = 0.003), that was related to an increase in subjective sleep efficiency and a decrease in sleep latency and disturbance (P ≤ 0.013). Weekly sitting time decreased, and the weekly amount of moderate and vigorous physical activity increased from T1 to T2 (P ≤ 0.049). No differences from T1 to T2 were observed in terms of mood, loneliness and state anxiety. A lower amount of sitting time was significantly correlated with improved subjective sleep quality (r = 0.096, P = 0.035) and with an increased amount of moderate (r = −0.126, P = 0.005) and vigorous (r = −0.110, P = 0.015) physical activity.ConclusionCompared to 3 weeks into the first COVID-imposed lockdown, 6-weeks after the start of the first COVID-imposed lockdown, physical activity and subjective sleep scores were positively impacted. The present, large sample size study further confirms exercise as a worthwhile countermeasure to psycho-physiological deconditioning during confinement.

Effects of Circadian Phase Tailored Light Therapy on Sleep, Mood, and Cognition in Alzheimer’s Disease: Preliminary Findings in a Pivotal Study

It is shown that the circadian system is affected in patients with Alzheimer’s disease (AD) even at an early stage of the disease and that such dysfunction may be detrimental to sleep, mood, and cognitive functioning. Light is a strong central modulator of the circadian rhythms and is potentially beneficial to mood and cognitive functioning via a direct effect or indirectly via its modulating effects on circadian rhythms. This study focuses on tracking the effect of light therapy on sleep quality, mood, and cognition in AD of mild/moderate severity. We performed a single-blind randomized controlled trial to investigate the effects of a light therapy treatment tailored to the individual circadian phase as measured by dim light melatonin onset (DLMO). Such a treatment induced an objective circadian phase shift consistent with the melatonin phase response curve to light exposure, led to a shortening of the phase angle DLMO-falling asleep time, and was associated with an improvement in subjective sleep quality and cognitive performance.

Insomnia subtypes characterised by objective sleep duration and NREM spectral power and the effect of acute sleep restriction: an exploratory analysis

Insomnia disorder (ID) is a heterogeneous disorder with proposed subtypes based on objective sleep duration. We speculated that insomnia subtyping with additional power spectral analysis and measurement of response to acute sleep restriction may be informative in overall assessment of ID. To explore alternative classifications of ID subtypes, insomnia patients (n = 99) underwent two consecutive overnight sleep studies: (i) habitual sleep opportunity (polysomnography, PSG) and, (ii) two hours less sleep opportunity (electroencephalography, EEG), with the first night compared to healthy controls (n = 25). ID subtypes were derived from data-driven classification of PSG, EEG spectral power and interhemispheric EEG asymmetry index. Three insomnia subtypes with different sleep duration and NREM spectral power were identified. One subtype (n = 26) had shorter sleep duration and lower NREM delta power than healthy controls (short-sleep delta-deficient; SSDD), the second subtype (n = 51) had normal sleep duration but lower NREM delta power than healthy controls (normal-sleep delta-deficient; NSDD) and a third subtype showed (n = 22) no difference in sleep duration or delta power from healthy controls (normal neurophysiological sleep; NNS). Acute sleep restriction improved multiple objective sleep measures across all insomnia subtypes including increased delta power in SSDD and NSDD, and improvements in subjective sleep quality for SSDD (p = 0.03), with a trend observed for NSDD (p = 0.057). These exploratory results suggest evidence of novel neurophysiological insomnia subtypes that may inform sleep state misperception in ID and with further research, may provide pathways for personalised care.

Mind-Body Integrative Health (MBIH) Interventions for Sleep among Adolescents: A Scoping Review of Implementation, Participation and Outcomes.

Adolescents get insufficient sleep, adversely affecting health. Mind-body integrative health interventions for adolescents have been shown to reduce stress, a barrier to good sleep. This scoping review aimed to synthesize mind-body integrative health interventions for adolescents, how interventions were implemented, who was reached. A systematic search of four online databases was conducted. Randomized, quasi-experimental, and single-group designs with participants ages 10-24 years were included. Twelve studies covering 10 interventions using mindfulness, qigong, aromatherapy, or yoga were identified. Participants were predominantly female; only one study reported participants' race or ethnicity (81% non-Hispanic white). Most (n=6) interventions were delivered in groups, and half reported significant improvements in subjective sleep quality. Mindfulness-based stress reduction and mindfulness-based cognitive therapy were the most commonly used modalities, with reported impact on sleep outcomes measured objectively. The two interventions that found statistically significant, moderate improvements in objectively-measured sleep onset latency and sleep efficiency were of higher intensity and used mindfulness. Four interventions were self-directed; participants in these struggled with adherence; significant impacts on sleep were not found. While findings were mixed, stemming in part from the quality of the underlying studies, this review identified several promising features of interventions, including using mindfulness, ensuring sufficient intervention dose, and targeting interventions towards adolescents with poor sleep at baseline (rather than a general population of adolescents). The findings suggests that sleep interventions for adolescents may improve psychological well-being as an intermediate effect, as sleep improvements were observed mostly among participants with poor sleep quality or anxiety symptoms at baseline. This review identified several gaps in the literature. Despite documented racial and ethnic disparities in sleep quality among adolescents, published evidence of mind-body integrative health-based sleep interventions among Black and Latinx adolescents is lacking. None of the studies in this review assessed developmental stage or age differences, despite documented differences in sleep across age groups of adolescents. These two gaps in the evidence should be addressed in future intervention research.

Effect of Benson and progressive muscle relaxation techniques on sleep quality after coronary artery bypass graft: A randomized controlled trial

ObjectiveThis study aimed to investigate the effect of Benson relaxation (BR) and progressive muscle relaxation (PMR) techniques on the sleep quality of patients undergoing coronary artery bypass graft (CABG) surgery. MethodThis study was a three-arm, parallel, randomized controlled trial. 120 patients who underwent CABG surgery at two academic hospitals in an urban area of Iran were randomly allocated into three groups (40 per group): the BR, PMR, and control groups. Patients in the BR and the PMR groups performed relevant exercises twice a day for four weeks. Sleep quality was measured before and immediately after the intervention using Pittsburgh Sleep Quality Index. ResultsWithin-group comparison in the BR (t = 3.51, p = 0.001) and the PMR (t = 4.58, p < 0.001) group showed that the overall sleep quality showed a significant improvement after the intervention when compared to baseline. The between-group comparison showed that both the BR and PMR groups showed significant improvements in subjective sleep quality (F = 3.75, p = 0.02), habitual sleep efficiency (F = 4.81, p = 0.01), and overall sleep quality (F = 5.53, p = 005) when compared to the control group after the intervention. However, no statistically significant differences were identified among the three study groups in terms of sleep latency, sleep duration, sleep disturbances, sleeping medication, and daytime dysfunction after the intervention (p > 0.05). ConclusionThe study showed that a four-week program of both PMR and BR can be effective in the overall improvement of sleep quality in patients following CABG. Further research is required to replicate the findings of the present study.

Therapeutic effects of traditional Thai herbal blood and wind tonic formulations for treatment of menopausal symptoms

IntroductionTraditional Thai herbal medicine formulations have been used as alternative therapies for menopausal symptoms due to concerns from adverse effects associated with hormone therapy. This study aimed to demonstrate the effects of traditional Thai herbal blood and wind tonic formulations used by a traditional Thai medicine doctor, Mr. Somporn Chanwanitsakul, in postmenopausal women. Materials and methodsA pilot clinical study was conducted on thirty-five postmenopausal women, referring to Tambon Thung Tam Sao Health Promotion Hospital, Hat Yai, Songkhla, from October 2019 to March 2020. The participants consumed combined Thai herbal formulations including blood tonic and wind tonic thrice daily for four weeks. Outcomes were assessed at baseline, end of treatment (4 weeks), and follow-up (8 weeks). Pre- and post-treatment measures included menopause rating scale, sleep quality, and quality of life questionnaire. All data were analyzed using SPSS software at the significance level of 0.05. ResultsTherapeutic effects of Thai herbal medicine formulations on menopausal symptoms intensity were assessed by modified Menopause Rating Scale (MRS). Severity of women's total menopausal symptoms decreased significantly (p < 0.05) at end of treatment and follow-up. Analysis of changes in specific symptoms indicated significantly less moderate headache, mild hot flashes, sweating, emotional instability, irritability, anxiety, sleep problem, lethargy, back pain, joint pain, muscular discomfort, dry skin, dryness of vagina, boring sex, and frequent urination (MRS score 0). In addition, subjective analysis of sleep quality using Pittsburgh Sleep Quality Index (PSQI) data revealed significant post-treatment improvements in subjective sleep quality and daytime dysfunction over the last month (PSQI score 0). Furthermore, subjective analysis of quality of life using World Health Organization Quality of Life Brief showed significant post-treatment improvement in psychological health (score 23). ConclusionThe findings demonstrate that Thai herbal medicine formulations used by a traditional Thai medicine doctor, Mr. Somporn Chanwanitsakul, are effective for treating menopausal symptoms and improve sleep quality and quality of life in postmenopausal women.