The evaluation of sleep disturbances for Chinese frontline medical workers under the outbreak of COVID-19

ObjectiveTo evaluate sleep disturbances of Chinese frontline medical workers (FMW) under the outbreak of coronavirus disease 2019 (COVID-19), and make a comparison with non-FMW.MethodsThe medical workers from multiple hospitals in Hubei Province, China, volunteered to participate in this cross-sectional study. An online questionnaire, including Pittsburgh Sleep Quality Index (PSQI), Athens Insomnia Scale (AIS) and Visual Analogue Scale (VAS), was used to evaluate sleep disturbances and mental status. Sleep disturbances were defined as PSQI>6 points or/and AIS>6 points. We compared the scores of PSQI, AIS, anxiety and depression VAS, as well as prevalence of sleep disturbances between FMW and non-FMW.ResultsA total of 1306 subjects (801 FMW and 505 non-FMW) were enrolled. Compared to non-FMW, FMW had significantly higher scores of PSQI (9.3 ± 3.8 vs 7.5 ± 3.7; P < 0.001; Cohen's d = 0.47), AIS (6.9 ± 4.3 vs 5.3 ± 3.8; P < 0.001; Cohen's d = 0.38), anxiety (4.9 ± 2.7 vs 4.3 ± 2.6; P < 0.001; Cohen's d = 0.22) and depression (4.1 ± 2.5 vs 3.6 ± 2.4; P = 0.001; Cohen's d = 0.21), as well as higher prevalence of sleep disturbances according to PSQI > 6 points (78.4% vs 61.0%; relative risk [RR] = 1.29; P < 0.001) and AIS > 6 points (51.7% vs 35.6%; RR = 1.45; P < 0.001).ConclusionFMW have higher prevalence of sleep disturbances and worse sleep quality than non-FMW. Further interventions should be administrated for FMW, aiming to maintain their healthy condition and guarantee their professional performance in the battle against COVID-19.     

The effectiveness of diaphragmatic breathing relaxation training for improving sleep quality among nursing staff during the COVID-19 outbreak: a before and after study

ObjectivesRecent studies have demonstrated that first-line nurses involved in the coronavirus disease-2019 (COVID-19) crisis may experience sleep disturbances. As breathing relaxation techniques can improve sleep quality, anxiety, and depression, the current study aimed to evaluate the effectiveness of diaphragmatic breathing relaxation training (DBRT) for improving sleep quality among nurses in Wuhan, China during the COVID-19 outbreak.MethodsThis study used a quasi-experimental (before and after) intervention strategy, with 151 first-line nurses from four wards in Leishenshan hospital. The Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) to evaluate the effectiveness of DBRT before and after the intervention. Data were examined using the Shapiro–Wilk test, Levene's test, and paired t-test.ResultsA total of 140 nurses completed the DBRT sessions. First-line nurses achieved significant reductions in global sleep quality (p < 0.01), subjective sleep quality (p < 0.001), sleep latency (p < 0.01), sleep duration (p < 0.001), sleep disturbances (p < 0.001), habitual sleep efficiency (p = 0.015), daytime dysfunction (p = 0.001), and anxiety (p = 0.001). There were no significant reductions in the use of sleeping medication (p = 0.134) and depression (p = 0.359).ConclusionDBRT is a useful non-pharmacological treatment for improving sleep quality and reducing anxiety among first-line nurses involved in the COVID-19 outbreak.The study protocol was clinically registered by the Chinese Clinical Trial Registry. Clinical Trial Registration number: ChiCTR2000032743.     

Restless Legs Syndrome masquerades as chronic insomnia

ObjectiveThe objective of this study is to emphasize the importance of the clinical suspicion of Restless Legs Syndrome (RLS) among patients with chronic insomnia.MethodsWe conducted a retrospective study referring to the period 2009–2018. All patients presenting with the complaint of insomnia and fulfilling the criteria of Chronic Insomnia (C.I.) were enrolled. In this group we estimated how many patients finally had the diagnosis of RLS. Demographic and clinical characteristics (sleep related problems, fatigue, daytime sleepiness and psychological profile) were recorded and analyzed between C.I. and RLS patients using logistic regression models.ResultsA total of 532 patients presented with C.I. Among them 83 proved to have RLS. No differences in frequencies or odds were observed concerning the type of insomnia, daily fatigue, daytime sleepiness and depression. RLS is more frequent in women (p = 0.01) and in older patients (p = 0.05) who present with the picture of C.I. Anxiety levels are higher in the RLS group (p = 0.004).ConclusionRLS and C.I. patients demonstrate a very similar profile which complicates the differential diagnosis. Physicians and especially psychiatrists who deal with insomnia must have increased clinical suspicion for RLS as RLS and insomnia have a totally different therapeutic approach.     

Sleep problems among Chinese adolescents and young adults during the coronavirus-2019 pandemic

ObjectiveTo assess the prevalence and sociodemographic correlates of insomnia symptoms among Chinese adolescents and young adults affected by the outbreak of coronavirus disease-2019 (COVID-19).MethodsThis cross-sectional study included Chinese adolescents and young adults 12–29 years of age during part of the COVID-19 epidemic period. An online survey was used to collect demographic data, and to assess recognition of COVID-19, insomnia, depression, and anxiety symptoms using the Pittsburgh Sleep Quality Index (PSQI), the Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder (GAD-7) questionnaires, respectively. The Social Support Rate Scale was used to assess social support.ResultsAmong 11,835 adolescents and young adults included in the study, the prevalence of insomnia symptoms during part of the COVID-19 epidemic period was 23.2%. Binomial logistic regression analysis revealed that female sex and residing in the city were greater risk factors for insomnia symptoms. Depression or anxiety were risk factors for insomnia symptoms; however, social support, both subjective and objective, was protective factors against insomnia symptoms. Furthermore, anxiety and depression symptoms were mediators of social support and insomnia symptoms.ConclusionsResults of this study revealed a high prevalence of sleep problems among adolescents and young adults during the COVID-19 epidemic, especially senior high school and college students, which were negatively associated with students’ projections of trends in COVID-19. The adverse impact of COVID-19 was a risk factor for insomnia symptoms; as such, the government must devote more attention to sleep disorders in this patient population while combating COVID-19.     

A meta-analysis of the relationship between subjective sleep and depressive symptoms in adolescence

BackgroundAdolescence is a risk period for the development of mental illness, as well as a time for pronounced change in sleep behaviour. While prior studies, including several meta-analyses show a relationship between sleep and depressive symptoms, there were many inconsistences found in the literature.ObjectiveTo investigate the relationship between subjective sleep and depressive symptoms.MethodsFollowing PRISMA guidelines, we conducted a literature search that yielded forty-nine recent studies (2014–2020) with adolescent samples aged 9 to 25-year-olds, and more than double the sample size of previous meta-analyses (N = 318,256).ResultsIn a series of meta-analyses, we show that while several common categories of subjective sleep are associated with depressive symptoms in adolescents, the strength of this relationship varies. Measures of sleep perception: poor sleep quality (r = 0.41), insomnia (r = 0.37), sleep disturbances (r = 0.36), wake after sleep onset (r = 0.31), and daytime sleepiness (r = 0.30) correlated more strongly with depressive symptoms, than measures of sleep behaviour: sleep latency (r = 0.22), and sleep duration (r = −0.19).ConclusionsThese findings suggest that in studies of depressive symptoms it may be important to assess an adolescent's perception about their sleep, in addition to their sleep/wake behaviours.     

Transcutaneous cervical vagus nerve stimulation reduces behavioral and physiological manifestations of withdrawal in patients with opioid use disorder: A double-blind,randomized, sham-controlled pilot study

BackgroundOpioid Use Disorder (OUD) is a serious public health problem, and the behavioral and physiological effects of opioid withdrawal can be a major impediment to recovery. Medication for OUD is currently the mainstay of treatment; however, it has limitations and alternative approaches are needed.ObjectiveThe purpose of this study was to assess the effects of transcutaneous cervical vagus nerve stimulation (tcVNS) on behavioral and physiological manifestations of acute opioid withdrawal.MethodsPatients with OUD undergoing acute opioid withdrawal were randomly assigned to receive double blind active tcVNS (N = 10) or sham stimulation (N = 11) while watching neutral and opioid cue videos. Subjective opioid withdrawal, opioid craving, and anxiety were measured using a Visual Analogue Scale (VAS). Distress was measured using the Subjective Units of Distress Scale (SUDS), and pain was measured using the Numerical Rating Scale (NRS) for pain. Electrocardiogram signals were measured to compute heart rate. The primary outcomes of this initial phase of the clinical trial (ClinicalTrials.gov NCT04556552) were heart rate and craving.ResultstcVNS compared to sham resulted in statistically significant reductions in subjective opioid withdrawal (p = .047), pain (p = .045), and distress (p = .004). In addition, tcVNS was associated with lower heart rate compared to sham (p = .026). Craving did not significantly differ between groups (p = .11).ConclusionstcVNS reduces behavioral and physiological manifestations of opioid withdrawal, and should be evaluated in future studies as a possible non-pharmacologic, easily implemented approach for adjunctive OUD treatment.     

Social jetlag is associated with obesity-related outcomes in 9–11-year-old children,independent of other sleep characteristics

IntroductionSocial jetlag has been reported to predict obesity-related indices, independent of sleep duration, with associations in female adolescents but not males. However, such sex-specific relationships have not been investigated in pre-adolescents.ObjectivesTo examine: (i) the relationships between sleep characteristics, including social jetlag, and obesity-related outcomes during childhood, and (ii) whether these relationships are moderated by sex.MethodsThis cross-sectional study included 381 children aged 9–11 years (49.6% female). Average sleep duration, social jetlag, and physical activity were assessed via wrist-worn accelerometry. Sleep disturbances were quantified from the Children's Sleep Habits Questionnaire. Obesity-related outcomes included age-specific body mass index Z-scores (zBMI) and waist-to-height ratio. Additionally % fat, total fat mass, and fat mass index were assessed via bioelectrical impedance analysis. Linear mixed models that nested children within schools were used to identify relationships among sleep characteristics and obesity-related outcomes.ResultsPositive associations between social jetlag with zBMI, % fat, and fat mass index were seen in univariable and unadjusted multivariable analyses. Following adjustments for known confounders, social jetlag remained significantly associated with zBMI (β = 0.12, p = 0.013). Simple slopes suggested a positive association in girls (β = 0.19, p = 0.006) but not in boys (β = 0.03, p = 0.703).ConclusionsObesity prevention efforts, particularly in girls, may benefit from targeted approaches to improving the consistency of sleep timing in youth.     

Parsing the antidepressant effects of non-invasive brain stimulation and pharmacotherapy: A symptom clustering approach on ELECT-TDCS

BackgroundTranscranial direct current stimulation (tDCS) presents small antidepressant efficacy at group level and considerable inter-individual variability of response. Its heterogeneous effects bring the need to investigate whether specific groups of patients submitted to tDCS could present comparable or larger improvement compared to pharmacotherapy. Aggregate measurements might be insufficient to address its effects.Objective/Hypothesis: To determine the efficacy of tDCS, compared to pharmacotherapy and placebo, in depressive symptom clusters.MethodsData from ELECT-TDCS (Escitalopram versus Electrical Direct-Current Therapy for Treating Depression Clinical Study, ClinicalTrials.gov, NCT01894815), in which antidepressant-free, depressed patients were randomized to receive 22 bifrontal tDCS (2 mA, 30 min) sessions (n = 94), escitalopram 20 mg/day (n = 91), or placebo (n = 60) over 10 weeks. Agglomerative hierarchical clustering identified “sleep/insomnia”, “core depressive”, “guilt/anxiety”, and “atypical” clusters that were the dependent measure. Trajectories were estimated using linear mixed regression models. Effect sizes are expressed in raw HAM-D units. P-values were adjusted for multiple comparisons.ResultsFor core depressive symptoms, escitalopram was superior to tDCS (ES = −0.56; CI_95% = -0.94 to −0.17, p = .009), which was superior to placebo (ES = 0.49; CI_95% = 0.06 to 0.92, p = .042). TDCS but not escitalopram was superior to placebo in sleep/insomnia symptoms (ES = 0.87; CI_95% = 0.22 to 1.52, p = .015). Escitalopram but not tDCS was superior to placebo in guilt/anxiety symptoms (ES = 1.66; CI_95% = 0.58 to 2.75, p = .006). No active intervention was superior to placebo for atypical symptoms.ConclusionsPharmacotherapy and non-invasive brain stimulation produce distinct effects in depressive symptoms. TDCS or escitalopram could be chosen according to specific clusters of symptoms for a bigger response.Trial registrationClinicalTrials.gov, NCT01894815     

Association of visceral adiposity and systemic inflammation with sleep disordered breathing in normal weight,never obese adolescents

Objective/backgroundWhile obesity is a known risk factor for sleep disordered breathing (SDB), a large proportion of children with SDB are not overweight as per body mass index percentile (BMI%) criteria. This study aimed to examine whether premorbid or concurrent adiposity phenotypes and inflammation are associated with SDB in normal weight youth.Patients/methodsA total of 242 persistently non-overweight (BMI%<85) subjects from the Penn State Child Cohort (PSCC, N = 421, 5-12 y at baseline and 12-23 y at follow-up), were studied. The apnea/hypopnea index (AHI) was ascertained via polysomnography (PSG) at both time points. At follow-up, a dual-energy X-ray absorptiometry (DXA) scan assessed android and gynoid distribution and subcutaneous (SAT) and visceral (VAT) adiposity composition, while a fasting blood draw was assayed for C-reactive protein (CRP) and interleukin-6 (IL-6) levels. Multivariable linear regression models with AHI at follow-up as primary outcome were adjusted for sex, race, adenotonsillectomy, age and AHI at baseline.Results and conclusionsIncreased waist circumference (β = 0.227, p = 0.001) at baseline, but not BMI%, neck or hip circumference, was significantly associated with a higher AHI at follow-up. VAT (β = 0.309, p < 0.001), IL-6 (β = 0.243, p < 0.001), SAT (β = 0.235, p = 0.013), CRP (β = 0.221, p = 0.001), and an android distribution (β = 0.196, p = 0.003) at follow-up were significantly associated with a higher AHI at follow-up. Childhood central adiposity predicts SDB in adolescence, even in individuals who have never been overweight since childhood as per BMI criteria. Visceral adiposity and inflammation are concurrent to adolescent SDB, which supports the clinical utility of these biomarkers in predicting its associated cardiometabolic risk.     

Validation of the Japanese version of the Sleep Hygiene Practice Scale

ObjectiveThis study sought to validate the Japanese version of the Sleep Hygiene Practices Scale (SHPS-J).Patients/methodsA cross-sectional questionnaire-based study was conducted via the internet. In total, 854 participants (435 men, 419 women; mean age, 42.91 ± 11.54 years) were asked to complete all scales, and 283 of them were asked to complete the same scales two weeks later. The survey consisted of the SHPS-J, the Japanese version of the Insomnia Severity Index (ISI-J), and the Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J). The SHPS-J was developed according to the International Society for Pharmacoeconomics and Outcomes Research Task Force for Translation and Cultural Adaption. For the analysis, participants were divided into three groups: insomnia syndrome, insomnia symptoms, and good sleep groups.ResultsThe SHPS-J had good test-retest reliability (ICC: 0.55–0.76) and adequate internal consistency (α = 0.54–0.74), except with regard to eating/drinking behaviors. The factorial validity of the four-factor structure was confirmed through a confirmatory factor analysis; however, one item related to eating/drinking behaviors had no significant factor loading. The construct validity was confirmed through a correlation analysis between each domain of the SHPS-J and ISI-J (r = 0.19–0.60, p < 0.01). The results of clinical validation confirmed that all domains of the SHPS-J were significantly higher for individuals with insomnia than for good sleepers.ConclusionsThis study confirmed both the reliability and validity of the SHPS-J.     

Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial

Objective/backgroundLemborexant is a dual orexin receptor antagonist approved in the United States, Japan, and Canada for the treatment of insomnia in adults. We report effectiveness and safety outcomes in subjects with insomnia who received up to twelve months of continuous lemborexant treatment in Study E2006-G000-303 (Study 303; SUNRISE-2).Patients/methodsStudy 303 was a twelve-month, global, multicenter, randomized, double-blind, parallel-group, Phase 3 study divided into two treatment periods. In Treatment Period 1 (first six months), subjects (n = 949, Full Analysis Set) were randomized to daily placebo, lemborexant 5 mg (LEM5) or lemborexant 10 mg (LEM10). In Treatment Period 2 (second six months), placebo subjects were rerandomized to LEM5 or LEM10, and subjects randomized to lemborexant continued their assigned treatment (LEM5, n = 251; LEM10, n = 226). Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored.ResultsFor all sleep parameters, the significant benefits observed with LEM5 and LEM10 versus placebo over six months were maintained at twelve months in subjects who received twelve continuous months of treatment. There was no evidence of rebound insomnia or withdrawal in either lemborexant group following treatment discontinuation. Over twelve months of lemborexant treatment, most TEAEs were mild/moderate; the most common TEAEs were nasopharyngitis, somnolence and headache.ConclusionsLEM5 and LEM10 had significant benefit on sleep onset and sleep maintenance compared with placebo, and importantly, lemborexant effectiveness persisted at twelve months, suggesting that lemborexant may provide long-term benefits for subjects with insomnia.Clinical trial registrationClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.     

Relationships between insomnia,long working hours,and long commuting time among public school teachers in Japan: a nationwide cross-sectional diary study

ObjectivesThe present study aimed to clarify the prevalence and risk factors of insomnia among public school teachers in Japan by examining the relationships between working hours, commuting time, and insomnia. Time spent on work activities among teachers with insomnia was also investigated.MethodsThis study was a secondary analysis of data obtained in a 2016 survey of working conditions among public elementary/junior high school teachers in Japan. A total of 11,390 teachers (women: 47.4%, average age: 42.2 ± 11.3 years) were selected for analysis. The relationships between working hours, commuting time, and insomnia were evaluated using a binomial logistic regression model. The primary outcome was insomnia, defined by a score of ≥6 on the Athens Insomnia Scale. Explanatory factors were working hours/week, commuting time/day, six subscales of occupational stress, age group, presence of children, type of job, type of the school, and the urbanicity of the school.ResultsIn total, 41.7% of men and 44.0% of women were classified into the insomnia group. The insomnia group spent more time preparing for lectures, and a significant association was observed between insomnia and long working hours and commuting time. Results of multivariate logistic regression analysis showed that long working hours, long commuting time, and urbanicity of the school were statistically significantly associated with insomnia.ConclusionsInsomnia is common among public school teachers in Japan. Our findings suggest the importance of reducing the time spent on working to prevent insomnia.     

Association between eveningness preference,socio-behavioral factors,and insomnia symptoms in Korean adolescents

Objective/BackgroundStudies focusing on insomnia in adolescents are relatively scarce compared to those on excessive daytime sleepiness. We aimed to investigate the prevalence of insomnia symptoms and associated factors in Korean high school students.Patients/methodsA total of 8565 students (girls: 4104) were investigated nationwide, across 15 South Korean districts using an online self-report questionnaire. Insomnia symptoms were evaluated using the Global Sleep Assessment Questionnaire. The participants’ mean age was 16.77 ± 0.85 years.ResultsThe prevalence of insomnia symptoms was 39.43% (n = 3377). Logistic regression was used to estimate the odds ratio (OR) of insomnia symptoms associated with sleep characteristics and social behaviors after adjusting for the relevant covariates. Evening preference (OR, 2.51, 95% CI, 2.20–2.86), perception of insufficient sleep (OR, 3.55, 95% CI, 3.11–4.06), snoring usually/always (OR, 1.25; 95% CI, 1.00–1.55), witnessed sleep apnea usually/always (OR, 1.70; 95% CI, 1.17–2.46), increased internet addiction (OR, 1.02; 95% CI, 1.02–1.03), bad sleep environment (OR, 1.77; 95% CI, 1.50–2.10), ≥3 private extra classes (OR, 1.23; 95% CI, 1.01–1.49), often coffee consumption (OR, 1.31; 95% CI, 1.10–1.56), and often nocturnal eating (OR, 1.24; 95% CI, 1.06–1.45) were associated with insomnia symptoms. Evening preference (OR, 3.48; 95% CI, 2.52–4.82) was also associated with insomnia symptoms in the perceived sufficient sleep subgroup.ConclusionInsomnia symptoms were common in Korean high school students. Evening preference was the major factor associated with insomnia symptoms. Various socio-behavioral factors were also associated with insomnia symptoms.     

Development and validation of the hypersomnia-specific beliefs scale

Objective/BackgroundPatients with Central hypersomnia, especially Narcolepsy type 1 and Idiopathic Hypersomnia (NT1 and IHS) often have psychological frustration in their daily lives. We aimed to develop the first scale of hypersomnia-specific beliefs (HSB).Patients/methodsWe developed the HSB scale consisting of three factors (“aversion toward doze”, “hypersensitivity toward others” reactions about my doze”, and “sense of defeat caused by doze”) with 12 items through interviews to 11 patients with NT1 and IHS. Validity and reliability of the HSB were evaluated cross-sectionally with 166 patients with NT1 and IHS and 375 controls. Simultaneously, scores of patient health questionnaire −2(PHQ-2), mini-Social Phobia Inventory (mini-SPIN), and Epworth Sleepiness Scale (ESS) were obtained.ResultsThis 3-factor model had enough fitness (χ2 = 60.25, df = 51, p = 0.18, TLI = 0.99, CFI = 0.99, RMSEA = 0.03), Cronbach's α coefficient being 0.90. The intraclass correlation coefficient was 0.76. Also, the area under the receiver operating characteristic curve (AUC = 0.88) confirmed good discrimination ability. A cut-off score of 38 resulted in a sensitivity of 90% and a specificity of 75%. Multiple linear regression analyses showed that these scales were independently associated with the HSB score; the PHQ-2 (β = 0.24, p = 0.002), mini-SPIN (β = 0.29, p < 0.001) and ESS (β = 0.15, p = 0.048).ConclusionsOur data suggest that the HSB scale measured beliefs in NT1 and IHS patients with good validity, reliability, and discrimination ability. The HSB scale assesses the negative beliefs specific to patents with NT1 and IHS. This scale could be applied to the development of novel psychotherapeutic approach to patients with NT1 and IHS.     

Subthalamic nucleus deep brain stimulation improves sleep in Parkinson's disease patients: a retrospective study and a meta-analysis

BackgroundMost Parkinson's patients suffered from sleep problems. There is increasing evidence that Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) has a positive effect on several sleep parameters, improving overall sleep quality in patients with PD. However, the results are controversial.MethodsWe performed a retrospective study and meta-analysis to assess the Parkinson's disease sleep scale (PDSS) in Parkinson's patients.ResultsWe reviewed our data of patients who underwent STN-DBS, and then extracted five other trials to perform a meta-analysis. The pooled results showed an advantage on post-operative PDSS in both our medical center and pooled results (MD = 20.41, 95% CI = [13.03, 27.79], I² = 61%, P < 0.001). There was a significant difference in Unified Parkinson's Disease Rating Scale (UPDRS)-Ⅲ score between pre and post-operation (MD = −12.59, 95% CI = [−14.70, −10.49], I² = 90%, P < 0.001). What's more, Parkinsonian medication was significantly lower in the post-operative groups after DBS (MD = −314.71, 95% CI = [−468.13, −161.28], I² = 53%, P < 0.001).ConclusionIn the retrospective study and meta-analysis of 6 trials, we found that DBS can significantly increase sleep quality. Furthermore, motor function improved and Parkinsonian medication was significantly decreased postoperatively. The sample size was enough and no further investigations would change the conclusion.     

Efficacy and quality of life after 6–9 years of deep brain stimulation for depression

BackgroundGiven the invasiveness of deep brain stimulation (DBS), the effect should prove to be stable over the long-term and translate into an improvement of quality of life (QOL).ObjectiveTo study the effectiveness and QOL up to nine years after the DBS surgery.MethodsWe treated 25 adult patients with major depression with DBS of the ventral anterior limb of the internal capsule (vALIC). We followed them up naturalistically for 6–9 years after surgery (mean: 7.7 [SD:1.5] years), including a randomized crossover phase after the first year comparing sham with active DBS. Symptom severity was quantified using the Hamilton Depression Scale with response defined as a ≥50% decrease of the score compared to baseline. Quality of life was measured using the WHOQOL-BREF, assessing 5 domains (general, physical, psychological, social, environmental).ResultsIntention-to-treat response rates remained mostly stable from Year 3 to last follow-up (Year 3, 5 and 6: 40%; Year 4: 36%; Last observation: 44%). General, physical, psychological (all P < 0.001) and the environmental (P = 0.02) domain scores increased during DBS optimization and remained stable over the long term. No statistically significant changes were detected on the social domain. Patients scored significantly higher during active than sham DBS on the psychological, social and environmental domains, and trended towards a higher score on the general and physical domains.ConclusionThis study shows continued efficacy of vALIC DBS in depression, which translates into an improvement of QOL providing further support for DBS as a durable treatment for TRD.     

Efficacy of pitolisant in patients with high burden of narcolepsy symptoms: pooled analysis of short-term,placebo-controlled studies

Study objectiveTo evaluate the efficacy of pitolisant, a histamine 3 (H₃)-receptor antagonist/inverse agonist, in adult patients with high burden of narcolepsy symptoms.MethodsData were pooled from two randomized, placebo-controlled, 7- or 8-week studies of pitolisant (titrated to a potential maximum dose of 35.6 mg/day) in adults with narcolepsy. Analyses included three independent patient subgroups: Epworth Sleepiness Scale (ESS) baseline score ≥16, Maintenance of Wakefulness Test (MWT) sleep latency ≤8 min, and ≥15 cataplexy attacks per week.ResultsThe analysis populations included 118 patients for ESS (pitolisant, n = 60; placebo, n = 58), 105 for MWT (pitolisant, n = 59; placebo, n = 46), and 31 for cataplexy (pitolisant, n = 20; placebo, n = 11). On the ESS, least-squares mean change from baseline was significantly greater for pitolisant (−6.1) compared with placebo (−2.3; P < 0.001). Significantly more pitolisant-treated patients were classified as treatment responders: ESS score reduction ≥3, 69.0% in the pitolisant group versus 35.1% in the placebo group (P = 0.001); final ESS score ≤10, 36.2% versus 10.5%, respectively (P = 0.005). On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017). Least-squares mean change in the weekly rate of cataplexy was significantly greater for pitolisant (−14.5; baseline, 23.9; final, 9.4) compared with placebo (−0.1; baseline, 23.1; final, 23.0; P = 0.004). Headache was the most common adverse event with pitolisant.ConclusionsPitolisant, at once-daily doses up to 35.6 mg, was efficacious for reducing excessive daytime sleepiness and cataplexy in patients with severe narcolepsy symptom burden.     

Academic and professional paths of narcoleptic patients: the Narcowork study

Objective/BackgroundTo study educational and professional pathways of narcoleptic patients and examine demographic, disease-related and environmental factors associated with a better academic and professional prognosis.Patients/MethodsIn sum, 69 narcoleptic patients (51 narcolepsy type 1 and 18 narcolepsy type 2, age 42.5 ± 18.2 years) were enrolled in this pilot monocentric cross-sectional study with a comparison group (80 age- and sex-matched controls) between October 2017 and July 2018 in Lyon Center for Sleep Medicine. They completed questionnaires about their academic and professional trajectories and specific scales of quality of life (EuroQol quality of life scale EQ-5D-3L), depression (beck depression inventory, BDI), sleepiness (Epworth Sleepiness Scale, ESS) and narcoleptic symptoms severity (narcolepsy severity scale, NSS).ResultsNo difference in grade repetition or final obtained diploma was observed between patients and controls, but patients evaluated their academic curricula as more difficult (45.5% vs 16.9%, p = 0.0007), complained for more attentional deficits (75% vs 22.1%, p < 0.0001), and had needed more educational reorientation (28.6% vs 9.9%, p = 0.01). Even if no difference was observed in occupational category and professional status, patients expressed significantly less satisfaction about their work. Patients had more signs of depression [OR severe depression = 4.4 (1.6–12.6), p = 0.02] and their quality of life was significantly decreased (67.3 ± 18.4 vs 80.6 ± 13.2, p = 0.0007) as compared to controls. Multivariate analysis showed that a more favorable professional career was associated with a better quality of life.ConclusionsEducational and professional pathways do not seem to be significantly impaired in narcoleptic patients, but their experience and quality of life are affected. These findings may allow to reassure patients and should lead to a more comprehensive management of the disease.Clinical trial registrationNarcowork, https://clinicaltrials.gov/ct2/show/NCT03173378, N° NCT03173378.     

Weekend catch-up sleep and depression: results from a nationally representative sample in Korea

BackgroundThere is limited information on the association between weekend catch-up sleep (CUS), which has beneficial effects on health, and depression. This study aimed to investigate the association between CUS and depression in adults.MethodsWe used the data of the Seventh Korea National Health and Nutrition Examination Survey, 2016. Depression was defined as Patient Health Questionnaire-9 score ≥10. We categorized CUS duration as ≤0, 0 < to 1, 1 < to 2, and >2 h.ResultsOf 5550 eligible participants, 3286 (54.9%), 1033 (19.5%), 723 (14.7%) and 508 (10.9%) had CUS duration ≤0, 0 < to 1, 1 < to 2, and >2 h, respectively; of these, the prevalence of depression was 7.0%, 4.2%, 2.9%, and 6.0%, respectively. Multivariable regression analyses including covariates revealed that individuals with CUS duration 1 < to 2 h had a significantly decreased risk of depression compared to individuals with CUS duration ≤0 h (odds ratio [OR] = 0.517, 95% CI = 0.309–0.865). Individuals with CUS duration 0 < to 1 h (OR = 0.731, 95% CI = 0.505–1.060) and >2 h (OR = 1.164, 95% CI = 0.718–1.886) showed no significantly different risk of depression.ConclusionsThe risk of depression in individuals with CUS duration 1 < to 2 h was lower than for those with CUS duration ≤0 h. This finding provides a better understanding on the association between CUS and depression; and can be a basis for better management of depression.     

Associations of sleep duration,sedentary behaviours and energy expenditure with maternal glycemia in pregnancy

BackgroundWomen with high levels of physical activity (PA) are less likely to develop gestational diabetes mellitus (GDM), but the relations with sleep and sedentary behaviours (SB) are more controversial. We aimed to investigate all three components (sleep, PA, and SB) and their association with maternal glucose in pregnancy.MethodsWe included 766 pregnant women recruited at first trimester and that we followed at second trimester. We collected blood samples, anthropometry and standardized questionnaires about lifestyle including PA, SB, and sleep duration at both visits. Women completed a 50 g glucose challenge test at first trimester and 75-g oral glucose tolerance test (OGTT) at second trimester. We conducted regression analyses to test cross-sectional associations between sleep, PA, and SB with maternal glucose levels while taking into account potential confounders (maternal age, pre-pregnancy body mass index (BMI), gravidity, and smoking). We considered linear and quadratic relationships.ResultsAt first trimester, we observed a linear relationship between shorter sleep duration and higher glucose levels, which was attenuated after adjustments for confounders. At second trimester, we found a quadratic relationship between sleep and glucose showing lowest levels at fasting and 1 h-post OGTT for women who slept 6–10 h/night. This association remained significant after adjusting for confounders and taking into account PA and/or SB. Greater amount of SB was associated with higher 1 h-glucose after adjustment for confounders (β = 0.132; SE = 0.047; P = 0.005).ConclusionsSleep duration is associated with glucose regulation in pregnancy, independently of PA and SB, and this association varies according to the period of gestation.