The effect of sleep–wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT

Study ObjectivesDigital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.MethodsIn a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analyzed using linear mixed modeling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (behavioral indices (BI-Z) and sleep disturbance indices (SI-Z)).ResultsdCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = −0.74; 95% confidence interval (CI) −1.04 to −0.52; 13.3%) and HADS (b = −0.40; 95% CI −0.73 to −0.18; 29.2%), while BI-Z mediated minor changes.ConclusionReductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention.Clinical trials Name: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I Registration number: NCT02558647 URL: https://clinicaltrials.gov/ct2/show/NCT02558647?cond=NCT02558647&draw=2&rank=1     

Pre-pandemic sleep reactivity prospectively predicts distress during the COVID-19 pandemic: The protective effect of insomnia treatment

The COVID-19 pandemic is a rare stressor that has precipitated an accompanying mental health crisis. Prospective studies traversing the pandemic's onset can elucidate how pre-existing disease vulnerabilities augured risk for later stress-related morbidity. We examined how pre-pandemic sleep reactivity predicted maladaptive stress reactions and depressive symptoms in response to, and during, the pandemic. This study is a secondary analysis of a randomised controlled trial from 2016 to 2017 comparing digital cognitive behavioural therapy for insomnia (dCBT-I) against sleep education (N = 208). Thus, we also assessed whether dCBT-I moderated the association between pre-pandemic sleep reactivity and pandemic-related distress. Pre-pandemic sleep reactivity was measured at baseline using the Ford Insomnia Response to Stress Test. In April 2020, participants were recontacted to report pandemic-related distress (stress reactions and depression). Controlling for the treatment condition and the degree of COVID-19 impact, higher pre-pandemic sleep reactivity predicted more stress reactions (β = 0.13, ± 0.07 SE, p = 0.045) and depression (β = 0.22, ± 0.07 SE, p = 0.001) during the pandemic. Further, the odds of reporting clinically significant stress reactions and depression during the pandemic were over twice as high in those with high pre-pandemic sleep reactivity. Notably, receiving dCBT-I in 2016–2017 mitigated the relationship between pre-pandemic sleep reactivity and later stress reactions (but not depression). Pre-pandemic sleep reactivity predicted psychological distress 3–4 years later during the COVID-19 pandemic, and dCBT-I attenuated its association with stress reactions, specifically. Sleep reactivity may inform prevention and treatment efforts by identifying individuals at risk of impairment following stressful events.     

Impact of the COVID-19 Pandemic on the Mental Health of Adolescent Students in Daegu,Korea

BackgroundIn February 2020, as coronavirus disease 2019 (COVID-19) spread rapidly in Daegu, South Korea, students in that region experienced many emotional difficulties. In this study, we analyzed the stress and emotional crisis experienced by students during the COVID-19 pandemic, its causative factors, and the factors that affect negative emotions.MethodsWe identified the demographic information related to the experiences of unbearable stress and emotional crisis and their causal factors at three points in time: before the pandemic, during its peak, and at the time of the survey (2–3 months after the peak). In addition, we analyzed the factors related to depression and anxiety experienced by students during the COVID-19 pandemic. The Korean version of the Patient Health Questionnaire 9 and the Korean version of the Generalized Anxiety Disorder 7 was used to assess for depressive and anxiety symptoms in the subject students, respectively.ResultsA total of 8,177 students participated in the analysis, with 4,072 boys (49.8%), 4,105 girls (50.2%), and 4,463 middle school students (54.6%) and 3,177 high school students (45.4%). The percentage of students who experienced unbearable stress was 9% before the COVID-19 pandemic, increased to 16% at the peak of the COVID-19 pandemic, then decreased to 12.7% at the time of the survey. Stress was experienced more by girls (18.1% versus 13.8% in boys; χ² = 28.159, P < 0.001) and high school students (19.0% versus 13.5% in middle school students; χ² = 45.437, P < 0.001). Overall, 7.6% experienced emotional crises during the COVID-19 pandemic, which was more prevalent in girls (10.1% versus 5.2% in boys; χ² = 71.025, P < 0.001) and in high school students (8.8% versus 6.7% in middle school students; χ² = 12.996, P < 0.001). Depression and anxiety was seen in 19.8% and 12.3% of students during the COVID-19 pandemic, respectively. The risk factors for depression and anxiety included unbearable stress before the COVID-19 pandemic (P < 0.001), mental health (P = 0.044), and age (P = 0.040), whereas resilience was identified as a protective factor for depression and anxiety (P = 0.001).ConclusionStudents in Daegu experienced lots of mental difficulties since the COVID-19 pandemic. It will be necessary to improve stress management and resilience to improve students'' mental health in disasters such as the COVID-19 pandemic.     

Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission

Study ObjectivesSleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission.MethodsThis secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi—Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.ResultsAt post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12).ConclusionsFindings demonstrate that an Internet-delivered CBT-I program can effectively increase users’ sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT00328250","term_id":"NCT00328250"}}NCT00328250     

Parental Mental Health and Children's Behaviors and Media Usage during COVID-19-Related School Closures

BackgroundCoronavirus disease 2019 (COVID-19) is different from previous disasters in that it continues to the present and has affected all aspects of family life. During epidemics, psychosocial support is not less important than infection control. During COVID-19-related school closures, prolonged partial closures of schools could have detrimental social and health consequences for children and may increase the burden on the family. Based on a community sample in Korea, this study identified parental concerns, children''s media usage, other various factors and examined whether parental stress level or depression were positively associated with problem behaviors, media exposure, and sleep problems of the primary school children during school closure under COVID-19.MethodsParticipants were 217 parents residing in Suwon, South Korea, who had primary school children and responded to a web-based questionnaire on parental concerns from school closure under COVID-19, subjective stress, depression, whether having received mental health services, and family characteristics; children''s sleep patterns, problem behaviors, media usage during the online-only class period, and changes in activity level following the pandemic.ResultsDuring school closure, children gained body weight, spent less time in physical activities and more in media usage. Besides online learning content (97.2%), YouTube was highly used content (87.6%), and games followed (78.3%). Parental subjective stress index was highly associated with parental depression (Pearson correlation 0.439, P < 0.001), children''s sleep problems (0.283, P < 0.001), tablet time (0.171, P = 0.012) and behavior problems (0.413, P < 0.001). Parental depression was associated with children''s sleep problems (0.355, P < 0.001), TV time (0.153, P = 0.024), tablet time (0.159, P = 0.019), and behavior problems (0.524, P < 0.001). Parents who previously received mental services seemed to be more concerned about the problems their children already have getting worse because of COVID-19 than the disease itself. Children''s sleep problem was associated with tablet (0.172, P = 0.011) and smartphone time (0.298, P < 0.001), but not its frequency.ConclusionDuring COVID-19-related school closures, many parents and children had various difficulties relating to mental health. Ongoing monitoring of mental health of high-risk groups and multiple support systems may need to be expanded to cover those parents having difficulty in caring for their children.     

Changes in the Health of Adolescent Athletes: A Comparison of Health Measures Collected Before and During the COVID-19 Pandemic

ContextIn spring 2020, schools closed to in-person teaching and sports were cancelled to control the transmission of COVID-19. The changes that affected the physical and mental health among young athletes during this time remain unknown.ObjectiveTo identify changes in the health (mental health, physical activity, and quality of life) of athletes that occurred during the COVID-19 pandemic.DesignCross-sectional study.SettingSample recruited via social media.Patients or Other ParticipantsA total of 3243 Wisconsin adolescent athletes (age = 16.2 ± 1.2 years, 58% female) were surveyed in May 2020 (During COVID-19). Measures for this cohort were compared with previously reported data for Wisconsin adolescent athletes (n = 5231; age = 15.7 ± 1.2 years, 47% female) collected in 2016 to 2018 (PreCOVID-19).Main Outcome Measure(s)Demographic information included sex, grade, and sport(s) played. Health assessments included the Patient Health Questionnaire-9 Item to identify depression symptoms, the Pediatric Functional Activity Brief Scale to gauge physical activity, and the Pediatric Quality of Life Inventory 4.0 to evaluate health-related quality of life. Univariable comparisons of these variables between groups were conducted via t or χ² tests. Means and 95% CIs for each group were estimated using survey-weighted analysis-of-variance models.ResultsCompared with preCOVID-19 participants, a larger proportion of During COVID-19 participants reported moderate to severe levels of depression (9.7% versus 32.9%, P < .001). Scores of the During COVID-19 participants were 50% lower (worse) on the Pediatric Functional Activity Brief Scale (mean [95% CI] = 12.2 [11.9, 12.5] versus 24.7 [24.5, 24.9], P < .001) and the Pediatric Quality of Life Inventory 4.0 compared with the PreCOVID-19 participants (78.4 [78.0, 78.8] versus 90.9 [90.5, 91.3], P < .001).ConclusionsDuring the COVID-19 pandemic, adolescent athletes described increased symptoms of depression, decreased physical activity, and decreased quality of life compared with adolescent athletes in previous years.     

Asociación entre alteraciones en el sueño y problemas de salud mental en los estudiantes de Medicina durante la pandemia de la COVID-19

IntroductionMedical students are a population vulnerable to poor sleep quality and sleep deprivation; these problems were accentuated during the COVID-19 pandemic. The objective was to evaluate the association between sleep disturbances and the presence of depression and anxiety in medical students during the pandemic.Materials and methodsCross-sectional, analytical study in medical students of a private university in Peru. Data were collected from May 22 to June 14, 2020, after 3 months of mandatory social isolation. The Patient Health Questionnaire (PHQ-9; ≥ 10), the Generalized Anxiety Disorder (GAD-7; ≥ 10) scale and the Insomnia Severity Index (ISI; ≥ 8) were used to assess depression, anxiety and insomnia, respectively. Poisson regressions with robust variance were used to calculate prevalence ratios.ResultsThe prevalence of depression, anxiety and insomnia was 28.5%, 29.5% and 60.1% respectively. It was found that those who had short sleep (RPa: 1.40, CI: 1.05-1.87, p: 0.024), who slept after 2:00 hours (RPa: 2.24, CI: 1.31-3.83, p: 0.003) and who presented insomnia (RPa: 7.12, CI: 3.70-13.73, p: < 0.001) had a higher prevalence of anxiety. Likewise, those who slept after 2:00 hours (RPa: 2.13, CI: 1.24-3.64, p: 0.006) and those who presented insomnia (RP: 8.82, CI: 4.17-18.68, p: < 0.001) had a higher prevalence of depression.ConclusionsShort sleep, bedtime and insomnia are factors associated with the prevalence of depression and anxiety.     

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy

Study ObjectivesDigital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.MethodsEligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.ResultsIndividuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.ConclusionsAt the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.     

Cognitive effects of split and continuous sleep schedules in adolescents differ according to total sleep opportunity

Study ObjectivesWe compared the basic cognitive functions of adolescents undergoing split (nocturnal sleep + daytime nap) and continuous nocturnal sleep schedules when total sleep opportunity was either below or within the recommended range (i.e. 6.5 or 8 h).MethodsAdolescent participants (age: 15–19 year) in the 8-h split (n = 24) and continuous (n = 29) sleep groups were compared with 6.5-h split and continuous sleep groups from a previous study (n = 58). These protocols involved two baseline nights (9-h time-in-bed [TIB]), 5 nights of sleep manipulation, 2 recovery nights (9-h TIB), followed by a second cycle of sleep manipulation (3 nights) and recovery (2 nights). Cognitive performance, subjective sleepiness, and mood were evaluated daily; sleep was assessed using polysomnography.ResultsSplitting 6.5 h of sleep with a mid-afternoon nap offered a boost to cognitive function compared to continuous nocturnal sleep. However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness, and mood.ConclusionsIn adolescents, the effects of split sleep on basic cognitive functions vary by the amount of total sleep obtained. As long as the total sleep opportunity across 24 h is within the recommended range, students may fulfill sleep requirements by adopting a split sleep schedule consisting of a shorter period of nocturnal sleep combined with a mid-afternoon nap, without significant impact on basic cognitive functions.Clinical trial registration{"type":"clinical-trial","attrs":{"text":"NCT04044885","term_id":"NCT04044885"}}NCT04044885.     

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial

Study ObjectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this noninferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).MethodsA total of 177 cancer patients were randomized to: (1) StanCBT-I (6 face-to-face CBT-I sessions; n = 59) or (2) StepCBT-I (n = 118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n = 65), while those with more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps < .001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue, and quality of life scores.Conclusion(s)The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.Trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).     

Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry

Background

Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID-19) pandemic.

Methods

A national registry, named DA-COVID-19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID-19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID-19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician- and patient-reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity.

Results

A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS-CoV-2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS-CoV-2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID-related death occurred.

Conclusions

Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab-treated patients.

     

The Prevalence of Depression,Anxiety and Associated Factors among the General Public during COVID-19 Pandemic: a Cross-sectional Study in Korea

BackgroundSince its first case confirmed on January 20, 2020, Korea has been through three waves of the COVID-19 pandemic. Fears of the fourth wave persist as new cases continue to emerge. In such unpredictable times, the mental well-being of people is of crucial importance. This study examined the levels of depression and anxiety and their predictors among the Korean general public in Busan, Korea, during the COVID-19 pandemic.MethodsWe conducted a cross-sectional study via a self-reported questionnaire administered to 2,288 adult residents (aged 19–60 years) of Busan, Korea. Participants'' depression and anxiety were assessed using the Korean version of the Patient Health Questionnaire-4 (PHQ-4), which consists of PHQ-2 and Generalized Anxiety Disorder-2 (GAD-2), with the cutoff score of 3.ResultsThe mean age of the participants was 39.71 years. COVID-19 had several psychosocial impacts on people. It was revealed that 80.3% had restrictions in outside activities, 47.3% reported financial difficulties, and 53.6% had a fear of death or fatal outcome when infected with COVID-19. We performed logistic regression analysis to identify the factors associated with depression and anxiety. A total of 30.7% participants were classified as at risk of depression based on cutoff score of 3 on PHQ-2. Logistic regression analysis revealed that changes in sleep pattern due to COVID-19 were most strongly associated with depression, followed by restrictions in outside activities due to social distancing and increased family conflicts due to COVID-19. Also, 22.6% participants were classified as at risk of anxiety based on a cutoff score of 3 on GAD-2. Analysis revealed that changes in sleep pattern due to COVID-19 were most strongly associated with anxiety, followed by spending a lot of time searching for COVID-19-related information and having a fear of death or fatal outcome when infected with COVID-19.ConclusionThe results are alarming; 30.7% had a PHQ-2 score of 3 or higher, indicating depression, and 22.6% had a GAD-2 score of 3 or higher, indicating anxiety. Changes in sleep pattern had the strongest association with both depression and anxiety. Our results can be used to formulate mental health policies tailored to the context of the city. Our findings suggest the high prevalence of depression and anxiety in the society during the COVID-19 pandemic, which places growing importance on early intervention for mental health problems during these times.     

Association of the COVID-19 Pandemic and Low-rescue Suicide Attempts in Patients Visiting the Emergency Department after Attempting Suicide

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic may increase the total number of suicide attempts and the proportion of low-rescue attempts. We investigated the factors affecting low-rescue suicide attempts using the risk-rescue rating scale (RRRS) among patients who visited the emergency department (ED) after attempting suicide before or during the COVID-19 pandemic.MethodsWe retrospectively investigated suicide attempts made by patients who visited our ED from March 2019 to September 2020. Patients were classified into two groups based on whether they attempted suicide before or during the COVID-19 pandemic. Data on demographic variables, psychiatric factors, suicide risk factors and rescue factors were collected and compared.ResultsA total of 518 patients were included in the study, 275 (53.1%) of whom attempted suicide during the COVID-19 pandemic. The proportion of patients who made low-rescue suicide attempts differed before and during the COVID-19 pandemic (37.1% vs. 28.8%) (P = 0.046). However, the proportions of patients who made high-risk suicide attempts and high-lethality suicide attempts did not significantly differ between the two periods. The independent risk factors for low-rescue suicide attempts were age and the COVID-19 pandemic (odds ratio [OR], 1.02; 95% confidence interval [CI], 1.00–1.03; P = 0.006) (OR, 1.52; 95% CI, 1.03–2.25; P = 0.034).ConclusionThe COVID-19 pandemic was associated with low-rescue suicide attempts in patients visiting the ED after attempting suicide. Thus, we need to consider the implementation of measures to prevent low-rescue suicide attempts during similar infectious disease crises.     

Clinical Pathway for Emergency Brain Surgery during COVID-19 Pandemic and Its Impact on Clinical Outcomes

BackgroundOne of the challenges neurosurgeons are facing in the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic is to balance COVID-19 screening with timely surgery. We described a clinical pathway for patients who needed emergency brain surgery and determined whether differences in the surgery preparation process caused by COVID-19 screening affected clinical outcomes.MethodsDuring the COVID-19 period, patients in need of emergency brain surgery in our institution were managed using a novel standardized pathway designed for COVID-19 screening. We conducted a retrospective review of patients who were hospitalized through the emergency room and underwent emergency brain surgery. A total of 32 patients who underwent emergency brain surgery from February 1 to June 30, 2020 were included in the COVID-19 group, and 65 patients who underwent surgery from February 1 to June 30, 2019 were included in the pre-COVID-19 group. The baseline characteristics, disease severity indicators, time intervals of emergency processes, and clinical outcomes of the two groups were compared. Subgroup analysis was performed between the immediate surgery group and the semi-elective surgery group during the COVID-19 period.ResultsThere were no significant differences in baseline characteristics and severity indicators between the pre-COVID-19 group and COVID-19 group. The time interval to skin incision was significantly increased in the COVID-19 group (P = 0.027). However, there were no significant differences in the clinical outcomes between the two groups. In subgroup comparison, the time interval to skin incision was shorter in the immediate surgery group during the COVID-19 period compared with the pre-COVID-19 group (P = 0.040). The screening process did not significantly increase the time interval to classification and admission for immediate surgery. The time interval to surgery initiation was longer in the COVID-19 period due to the increased time interval in the semi-elective surgery group (P < 0.001).ConclusionWe proposed a clinical pathway for the preoperative screening of COVID-19 in patients requiring emergency brain surgery. No significant differences were observed in the clinical outcomes before and after the COVID-19 pandemic. The protocol we described showed acceptable results during this pandemic.     

Prospective examination of adolescent sleep patterns and behaviors before and during COVID-19

Study ObjectivesTo prospectively examine changes in adolescent sleep before and during the COVID-19 pandemic in adolescents with and without ADHD.MethodsParticipants were 122 adolescents (ages 15–17; 61% male; 48% with ADHD). Parents reported on adolescents’ sleep duration and difficulties initiating and maintaining sleep (DIMS); adolescents reported on sleep patterns, sleep duration, delayed sleep/wake behaviors, and daytime sleepiness before (September 2019 to February 2020) and during (May–June 2020) COVID-19. Adolescents also reported on their health behaviors, COVID-19-related negative affect, and difficulties concentrating due to COVID-19.ResultsParents reported adolescents had more DIMS during COVID-19 than before COVID-19, with clinically elevated rates increasing from 24% to 36%. Both bedtimes and waketimes shifted later during COVID-19, and adolescents reported more delayed sleep/wake behaviors. Adolescents also reported less daytime sleepiness and longer school night sleep duration during COVID-19. In considering differences between adolescents with and without ADHD, adolescents with ADHD did not experience an increase in school night sleep duration and were less likely to obtain recommended sleep duration during COVID-19. In the full sample, controlling for ADHD status, COVID-19-related sadness/loneliness was associated with increases in DIMS, and spending less time outside and more COVID-19-related worries/fears were associated with increases in delayed sleep/wake behaviors during COVID-19.ConclusionsCOVID-19 had negative and positive impacts on adolescent sleep. Adolescents with ADHD did not experience the benefit of increased school night sleep duration during COVID-19 like adolescents without ADHD. Negative affect and health behaviors may be useful intervention targets for reducing negative impacts of COVID-19 for adolescent sleep.     

The Impact of the COVID-19 Pandemic in Adolescents with Asthma

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic is affecting people at any age and there is limited information about the effect of the COVID-19 pandemic on quality of life (QoL) in adolescents with asthma. In the present study, it was aimed to assess the attitudes of adolescents with asthma toward the COVID-19 pandemic and determine the effects of the pandemic on their QoL.MethodsIn total, 125 adolescents with asthma and 98 healthy adolescents participated in the present study. The questionnaire form consisted of three parts. In the first part, all the participants were asked whether they complied with the protective measures against COVID-19. The second part included questions for measuring the participants’ level of concern about COVID-19, while the third part consisted of EUROHIS-QOL 8.ResultsThe patient and control groups were similar in terms of the female/male ratio (55/70 and 48/50, respectively) and mean participant age (14.6 ± 2 and 15.1 ± 1.65 years, respectively) (P = 0.459 and P = 0.062, respectively). The prevalence of COVID-19 in the patients (n = 2, 1.6%) was lower than that in the controls (n = 6, 6.1%); however, the difference was not statistically significant (P = 0.142). The total EUROHIS-QOL score was significantly lower in the patients (31.2 ± 6.7) than in the controls (33.7 ± 4.4) (P < 0.001). The total QoL scores of asthmatic adolescents without other allergic disease (31.4 ± 6.7) was also lower than those of the controls (33.7 ± 4.4) (P = 0.009). Treatment disruption was significantly more common in patients who received subcutaneous immunotherapy (n = 20, 48.8%) than in those who did not (n = 8, 9.5%) (P < 0.001). Moreover, the patients had lower EUROHIS-QOL scores in the overall QoL, general health, finance, and home domains.ConclusionOur results indicate that the mean QoL score of asthmatic adolescents during COVID-19 pandemic is lower than in the healthy population. Disruption in their treatment was most common in patients with asthma who were receiving subcutaneous immunotherapy.     

The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging

Study ObjectivesThe development of ambulatory technologies capable of monitoring brain activity during sleep longitudinally is critical for advancing sleep science. The aim of this study was to assess the signal acquisition and the performance of the automatic sleep staging algorithms of a reduced-montage dry-electroencephalographic (EEG) device (Dreem headband, DH) compared to the gold-standard polysomnography (PSG) scored by five sleep experts.MethodsA total of 25 subjects who completed an overnight sleep study at a sleep center while wearing both a PSG and the DH simultaneously have been included in the analysis. We assessed (1) similarity of measured EEG brain waves between the DH and the PSG; (2) the heart rate, breathing frequency, and respiration rate variability (RRV) agreement between the DH and the PSG; and (3) the performance of the DH’s automatic sleep staging according to American Academy of Sleep Medicine guidelines versus PSG sleep experts manual scoring.ResultsThe mean percentage error between the EEG signals acquired by the DH and those from the PSG for the monitoring of α was 15 ± 3.5%, 16 ± 4.3% for β, 16 ± 6.1% for λ, and 10 ± 1.4% for θ frequencies during sleep. The mean absolute error for heart rate, breathing frequency, and RRV was 1.2 ± 0.5 bpm, 0.3 ± 0.2 cpm, and 3.2 ± 0.6%, respectively. Automatic sleep staging reached an overall accuracy of 83.5 ± 6.4% (F1 score: 83.8 ± 6.3) for the DH to be compared with an average of 86.4 ± 8.0% (F1 score: 86.3 ± 7.4) for the 5 sleep experts.ConclusionsThese results demonstrate the capacity of the DH to both monitor sleep-related physiological signals and process them accurately into sleep stages. This device paves the way for, large-scale, longitudinal sleep studies.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT03725943","term_id":"NCT03725943"}}NCT03725943.     

Blunted rest–activity rhythms link to higher body mass index and inflammatory markers in children

Study ObjectivesDisturbances of rest–activity rhythms are associated with higher body mass index (BMI) in adults. Whether such relationship exists in children is unclear. We aimed to examine cross-sectional associations of rest–activity rhythm characteristics with BMI z-score and obesity-related inflammatory markers in school-age children.MethodsParticipants included 411 healthy children (mean ± SD age 10.1 ± 1.3 years, 50.8% girls) from a Mediterranean area of Spain who wore wrist accelerometers for 7 consecutive days. Metrics of rest–activity rhythm were derived using both parametric and nonparametric approaches. Obesity-related inflammatory markers were measured in saliva (n = 121).ResultsIn a multivariable-adjusted model, higher BMI z-score is associated with less robust 24-h rest–activity rhythms as represented by lower relative amplitude (–0.16 [95% CI –0.29, –0.02] per SD, p = 0.02). The association between BMI z-score and relative amplitude persisted with additional adjustment for sleep duration, and attenuated after adjustment for daytime activity level. Less robust rest–activity rhythms were related to increased levels of several salivary pro-inflammatory markers, including C-reactive protein, which is inversely associated with relative amplitude (–32.6% [–47.8%, –12.9%] per SD), independently of BMI z-score, sleep duration, and daytime activity level.ConclusionBlunted rest–activity rhythms are associated with higher BMI z-score and salivary pro-inflammatory markers already at an early age. The association with BMI z-score seem to be independent of sleep duration, and those with pro-inflammatory markers further independent of BMI z-score and daytime activity. Novel intervention targets at an early age based on improving the strength of rest–activity rhythms may help to prevent childhood obesity and related inflammation.Clinical Trials Registration{"type":"clinical-trial","attrs":{"text":"NCT02895282","term_id":"NCT02895282"}}NCT02895282     

Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis

Study ObjectivesPoor sleep quality affects nearly one-third of breast cancer survivors and is associated with insulin resistance. The purpose of this secondary analysis was to examine the effects of a 16-week exercise intervention on patient-reported sleep quality among breast cancer survivors and assess whether changes in patient-reported sleep quality were associated with cardiometabolic biomarkers. We explored Hispanic ethnicity as a moderator of the effects of exercise on patient-reported sleep quality.MethodsBreast cancer survivors who were overweight or obese were randomized to exercise (n = 50) or usual care (n = 50). The 16-week intervention included aerobic and resistance exercise. Patient-reported sleep quality (Pittsburgh Sleep Quality Index [PSQI]) and biomarkers of cardiometabolic health were assessed at baseline and post-intervention. Within- and between-group differences were assessed using general linear models repeated-measures analyses of variance and mixed-model repeated-measure analysis, respectively. Associations between changes in PSQI and cardiometabolic biomarkers were computed using Pearson correlations. Linear mixed-models were used to evaluate effect modification by ethnicity.ResultsParticipants were 52 ± 10.4 years old, and over half were of Hispanic ethnicity. As compared to usual care, PSQI global scores improved significantly in the exercise group (mean between-group difference −2.2; 95% CI −3.2 to −0.6). Change in PSQI was inversely associated with changes in all cardiometabolic biomarkers (p < 0.01) among the exercise group. Ethnicity was found to moderate the effects of exercise training on global sleep quality (p < 0.001).ConclusionsAn aerobic and resistance exercise intervention effectively improved patient-reported sleep quality in breast cancer survivors. Hispanic ethnicity as a moderator showed greater improvement in patient-reported sleep indicating Hispanic versus non-Hispanic breast cancer survivors may derive larger sleep benefits.Clinical Trail Information{"type":"clinical-trial","attrs":{"text":"NCT01140282","term_id":"NCT01140282"}}NCT01140282.     

Eszopiclone versus zopiclone in the treatment of insomnia

OBJECTIVE:To determine the therapeutic effects of two selective GABA-A agonists, zopiclone and eszopiclone, in the treatment of insomnia.METHODS:This study comprised a phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial. Patients were randomized to receive zopiclone 7.5 mg or eszopiclone 3 mg, both orally, for four weeks. In total, 199 patients were evaluated during two visits and then followed for at least six weeks. The primary endpoint was the Insomnia Severity Index after four weeks of treatment. Secondary endpoints were obtained through polysomnography data, including total sleep time, sleep latency and sleep efficiency. The frequency of adverse events was also analyzed. ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01100164","term_id":"NCT01100164"}}NCT01100164.RESULTS:The primary efficacy analysis demonstrated the non-inferiority of eszopiclone over zopiclone. Analysis of objective parameters assessed by polysomnography showed that eszopiclone increased total sleep time and also improved sleep efficiency. The safety profile of both study treatments was similar and the most common events reported in both groups were dysgeusia, headache, dizziness, irritability and nausea. Adverse events were observed in 223 patients, 109 (85.2%) in the eszopiclone group and 114 (87.7%) in the zopiclone group.CONCLUSION:Based on the Insomnia Severity Index at the end of four weeks of treatment, eszopiclone demonstrated efficacy comparable to that of zopiclone in the treatment of insomnia, increasing total sleep time as well as sleep efficiency according to polysomnography.