Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.

Objective: To describe lumateperone for the treatment of schizophrenia in adults using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).Methods: Data were obtained from the 3 phase 2/3 lumateperone trials, conducted between 2011 and 2016, in patients with schizophrenia diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or Fifth Edition. Efficacy was assessed using various response criteria; tolerability was principally assessed using rates of adverse events (AEs).Results: Pooled data of the 2 informative studies showed statistically significant estimates of NNT versus placebo for lumateperone 42 mg/d for the responder thresholds of ≥ 20% and ≥ 30% improvement on Positive and Negative Syndrome Scale (PANSS) total scores, with NNT for response versus placebo at 4 weeks and endpoint of 9 (95% confidence interval [CI], 5-36) and 8 (95% CI, 5-21), respectively. Pooling all studies, discontinuation because of AEs was uncommon, and the NNH versus placebo was 389 (not statistically significant from placebo [NS]). Rates of individual AEs resulted in NNH versus placebo > 10 except for somnolence/sedation (NNH of 8; 95% CI, 6-12). The occurrence of weight gain ≥ 7% from baseline yielded a NNH estimate of 122 (NS). Rates of akathisia were lower for patients receiving lumateperone compared with placebo. LHH for response versus somnolence/sedation was ~ 1 for lumateperone (similar to the risperidone active control group); otherwise, lumateperone exhibited LHH ratios that were much greater than 1 for all other AEs and that ranged from 13.6 to 48.6 for these other benefit-risk calculations.Conclusions: In 3 phase 2/3 trials, the benefit-risk assessment of lumateperone was favorable as measured by NNT, NNH, and LHH.Trial Registration: ClinicalTrials.gov identifiers: NCT01499563, NCT02282761, NCT02469155.

The Effect of Partial Sleep Deprivation and Time-on-Task on Young Drivers' Subjective and Objective Sleepiness.

Despite sleepiness being considered one of the main factors contributing to road crashes, and even though extensive efforts have been made in the identification of techniques able to detect it, the assessment of fitness-to-drive regarding driving fatigue and sleepiness is still an open issue. In the literature on driver sleepiness, both vehicle-based measures and behavioral measures are used. Concerning the former, the one considered more reliable is the Standard Deviation of Lateral Position (SDLP) while the PERcent of eye CLOSure over a defined period of time (PERCLOS) seems to be the most informative behavioral measure. In the present study, using a within-subject design, we assessed the effect of a single night of partial sleep deprivation (PSD, less than 5 h sleeping time) compared to a control condition (full night of sleep, 8 h sleeping time) on SDLP and PERCLOS, in young adults driving in a dynamic car simulator. Results show that time-on-task and PSD affect both subjective and objective sleepiness measures. Moreover, our data confirm that both objective and subjective sleepiness increase through a monotonous driving scenario. Considering that SDLP and PERCLOS were often used separately in studies on driver sleepiness and fatigue detection, the present results have potential implications for fitness-to-drive assessment in that they provide useful information allowing to combine the advantages of the two measures for drowsiness detection while driving.

Daytime Napping Benefits Passing Performance and Scanning Activity in Elite Soccer Players.

The present study explored the effect of a daytime napping opportunity on scanning activity, which is an essential component of successful soccer performance. Fourteen male elite collegiate soccer players performed the Trail Making Test (TMT), which was used to assess complex visual attention. In addition, a soccer passing test, modified with reference to the Loughborough Soccer Passing Test, was used to evaluate passing performance as well as scanning activity. A cross-over design was applied to examine nap and no-nap interventions. Participants (N = 14, mean age: 21.6 SD = 0.5 years, height: 1.73 ± 0.06 m, body mass: 67.1 ± 4.5 kg) were randomly allocated to a midday nap (40 minutes) or no-nap group. Subjective sleepiness was measured using the Karolinska Sleepiness Scale, and perceptive fatigue was evaluated by the visual analog scale. There were no significant differences in subjective measurements or TMT between the nap and no-nap groups. However, the performance time for the passing test and scanning activity was significantly shorter (p < 0.001) and scanning activity was significantly more frequent in the nap condition than in the no-nap condition (p < 0.00005). These results suggest that daytime napping is beneficial for soccer-related cognitive function, represented by visuospatial processing and decision-making, and particularly as a potential countermeasure to mental fatigue. Considering that inadequate sleep and residual fatigue are commonly observed in elite soccer, this finding may have practical implications for the preparation of players.

Sleep Architecture and Sleep-Related Breathing Disorders of Seafarers on Board Merchant Ships: A Polysomnographic Pilot Field Study on the High Seas.

As seafarers are assumed to have an increased risk profile for sleep-related breathing disorders, this cross-sectional observational study measured (a) the feasibility and quality of polysomnography (PSG) on board merchant ships, (b) sleep macro- and microarchitecture, (c) sleep-related breathing disorders, such as obstructive sleep apnea (OSA), using the apnea-hypopnea index (AHI), and (d) subjective and objective sleepiness using the Epworth Sleepiness Scale (ESS) and pupillometry. Measurements were carried out on two container ships and a bulk carrier. A total of 19 out of 73 male seafarers participated. The PSG's signal qualities and impedances were comparable to those in a sleep laboratory without unusual artifacts. Compared to the normal population, seafarers had a lower total sleep time, a shift of deep sleep phases in favor of light sleep phases as well as an increased arousal index. Additionally, 73.7% of the seafarers were diagnosed with at least mild OSA (AHI ≥ 5) and 15.8% with severe OSA (AHI ≥ 30). In general, seafarers slept in the supine position with a remarkable frequency of breathing cessations. A total of 61.1% of the seafarers had increased subjective daytime sleepiness (ESS > 5). Pupillometry results for objective sleepiness revealed a mean relative pupillary unrest index (rPUI) of 1.2 (SD 0.7) in both occupational groups. In addition, significantly poorer objective sleep quality was found among the watchkeepers. A need for action with regard to poor sleep quality and daytime sleepiness of seafarers on board is indicated. A slightly increased prevalence of OSA among seafarers is likely.

Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety (ME-SMART): a monocentric, controlled, randomized, crossover trial.

BACKGROUND: Too little sleep and the consequences thereof are a heavy burden in modern societies. In contrast to alcohol or illicit drug use, there are no quick roadside or workplace tests for objective biomarkers for sleepiness. We hypothesize that changes in physiological functions (such as sleep-wake regulation) are reflected in changes of endogenous metabolism and should therefore be detectable as a change in metabolic profiles. This study will allow for creating a reliable and objective panel of candidate biomarkers being indicative for sleepiness and its behavioral outcomes. METHODS: This is a monocentric, controlled, randomized, crossover, clinical study to detect potential biomarkers. Each of the anticipated 24 participants will be allocated in randomized order to each of the three study arms (control, sleep restriction, and sleep deprivation). These only differ in the amount of hours slept per night. In the control condition, participants will adhere to a 16/8 h wake/sleep regime. In both sleep restriction and sleep deprivation conditions, participants will accumulate a total sleep deficit of 8 h, achieved by different wake/sleep regimes that simulate real-life scenarios. The primary outcome is changes in the metabolic profile (i.e., metabolome) in oral fluid. Secondary outcome measures will include driving performance, psychomotor vigilance test, d2 Test of Attention, visual attention test, subjective (situational) sleepiness, electroencephalographic changes, behavioral markers of sleepiness, changes in metabolite concentrations in exhaled breath and finger sweat, and correlation of metabolic changes among biological matrices. DISCUSSION: This is the first trial of its kind that investigates complete metabolic profiles combined with performance monitoring in humans over a multi-day period involving different sleep-wake schedules. Hereby, we aim to establish a candidate biomarker panel being indicative for sleepiness and its behavioral outcomes. To date, there are no robust and easily accessible biomarkers for the detection of sleepiness, even though the vast damage on society is well known. Thus, our findings will be of high value for many related disciplines. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05585515, released on 18.10.2022; Swiss National Clinical Trial Portal SNCTP000005089, registered on 12 August 2022.

[The optimal examination duration for the detection of epileptiform discharge in outpatient video-electroencephalography].

Objective: To determine the optimal examination duration by evaluating the detection rate of epileptiform discharges (EDs) with different examination duration of video-electroencephalography (EEG) in outpatients. Methods: Patients with EDs who underwent 4-hour EEG examination from Xuanwu Hospital, Capital Medical University from October 2020 to November 2021 were retrospectively enrolled, and the detection rates of EDs were calculated with examination duration of 0-0.5 h, 0-1 h, 0-2 h, 0-3 h, and 0-4 h (group A, B, C, D and E), respectively. For each patient, EDs in each hour (group H1, group H2, group H3, group H4) were counted, and the standardized amount of EDs was calculated. For each patient, EDs in wakefulness, drowsiness, non-rapid eye movement-Ⅰ (NREM-Ⅰ), NREM-Ⅱ and NREM-Ⅲ were counted, and the standardized amount of EDs in each state was calculated. Meanwhile, the sleep duration per hour of each patient was also counted (group H1', group H2', group H3', group H4'). The Wilcoxon paired test was used for intergroup comparison to determine the optimal examination duration. Results: A total of 80 patients were enrolled, and aged [M(Q1, Q3)]31 (21, 39) years (range: 5-68 years). There were 38 males and 42 females. The detection rate of EDs was 42.5% (34/80) in group A, 81.3% (65/80) in group B, and 100.0% (80/80) in group C, group D and group E, respectively. The standardized amount of EDs of H1, H2, H3 and H4 was 24.8% (7.8%, 44.2%), 41.5% (25.9%, 63.3%), 15.1% (1.3%, 27.8%) and 1.3% (0, 14.5%), respectively. The standardized amount of EDs of H2 was significantly higher than that of H1, H3 and H4 (all P<0.05). The standardized amount of EDs in wakefulness, drowsiness, NREM-Ⅰ, NREM-Ⅱ and NREM-Ⅲ were 9.6% (0, 28.2%), 3.6% (0, 16.9%), 3.3% (0, 11.8%), 47.3% (21.9%, 72.5%) and 0 (0, 11.5%), respectively. The standardized amount of EDs in NREM-Ⅱ was significantly higher than that in wakefulness, drowsiness, NREM-Ⅰ and NREM-Ⅲ (all P<0.05). The sleep duration in the group of the H1', H2', H3' and H4' was 13.6 (2.5, 23.6), 35.8 (16.5, 54.2), 14.5(0, 34.7) and 0 (0, 14.6) minutes, respectively. The sleep duration in the group of the H2' group was significantly longer than that in the group of H1', H3' and H4' (all P<0.05). Conclusion: The study recommends 2 hours video-EEG in outpatients, which not only ensures the detection rate of EDs, but also facilitates patient cooperation and optimizes the allocation of medical resources.

Using Light to Facilitate Circadian Entrainment from Day to Night Flights.

BACKGROUND: As part of a larger project to provide recommendations regarding limitations and best practices for shifting aviators from day to night operations, a study was conducted to assess the efficacy of high energy visible (HEV) light to shift the circadian rhythm in humans. The study attempted to replicate the patterns of military aviators who could be required to shift abruptly from day to night flight operations.METHODS: Simulated flight performance and salivary melatonin levels of 10 U.S. military aviators were collected over a 3-night period using a within-subject dim light melatonin onset (DLMO) study design. Data were collected in a laboratory with participants returning home to sleep following each of the three evenings/nights of data collection. Light treatment included a single 4-h exposure of blue-enriched white light (∼1000 lux) on night 2. Data collected included melatonin levels, light exposure, sleepiness, cognitive workload, and simulated flight performance.RESULTS: The average delay in melatonin onset was 1.32 ± 0.37 h (range: 53 min to 1 h 56 min). Sleepiness (P = 0.044) and cognitive workload (P = 0.081) improved the night following the light treatment compared to the baseline. No systematic differences were identified in flight performance.DISCUSSION: The HEV light treatment successfully delayed the circadian phase of all participants even though participants' ambient light levels (including daylight) outside the laboratory were not controlled. These findings were used to develop circadian synchronization plans for aviators who are asked to transition from day to night operations. These plans will be assessed in a follow-on study in an operational unit.Shattuck NL, Matsangas P, Reily J, McDonough M, Giles KB. Using light to facilitate circadian entrainment from day to night flights. Aerosp Med Hum Perform. 2023; 94(2):66-73.

Residual Sleepiness Risk in Aircrew Members with -Obstructive Sleep Apnea Syndrome.

BACKGROUND: Obstructive sleep apnea syndrome (OSAS) is a major problem in aviation medicine because it is responsible for sleepiness and high cardiovascular risk, which could jeopardize flight safety. Residual sleepiness after the treatment is not a rare phenomenon and its management is not homogenous in aviation medicine. Thus, we decided to perform a study to describe this management and propose guidelines with the help of the literature.METHODS: This is a retrospective study including all aircrew members with a history of OSAS who visited our aeromedical center between 2011 and 2018. Residual sleepiness assessment was particularly studied.RESULTS: Our population was composed of 138 aircrew members (mean age 50.1 ± 9.6 yr, 76.8% civilians, 80.4% pilots); 65.4% of them had a severe OSAS with a mean Epworth Sleepiness Scale (ESS) at 8.5 ± 4.7 and a mean apnea hypopnea index of 36.2 ± 19.2/h. Of our population, 59.4% performed maintenance of wakefulness tests (MWT) and 10.1% had a residual excessive sleepiness. After the evaluation, 83.1% of our population was fit to fly.DISCUSSION: An evaluation of treatment efficiency is required in aircrew members with OSAS. Furthermore, it is important to have an objective proof of the absence of sleepiness. In this case, ESS is not sufficient and further evaluation is necessary. Many tests exist, but MWT are generally performed and the definition of a normal result in aeronautics is important. This evaluation should not be reserved to solo pilots only.Monin J, Rebiere E, Guiu G, Bisconte S, Perrier E, Manen O. Residual sleepiness risk in aircrew members with obstructive sleep apnea syndrome. Aerosp Med Hum Perform. 2023; 94(2):74-78.

Diurnal symptoms of sleepiness and dysfunction predict future suicidal ideation in a French cohort of outpatients (FACE-DR) with treatment resistant depression: A 1-year prospective study about sleep markers.

BACKGROUND: Patients suffering from treatment-resistant depression (TRD) are at risk of suicide. Sleep and circadian rhythm alterations are widely recognized as core symptoms of major depressive disorder and are associated with suicidal ideation. Thus, sleep and circadian rhythm alterations may be targeted to prevent suicide. METHODS: Patients were recruited from a prospective cohort of the French network of TRD expert centers. Mood, sleep and circadian rhythms were assessed at baseline; suicidal risk was assessed both at baseline and during a one-year follow-up with standardized subjective questionnaires. RESULTS: Excessive daytime sleepiness (adjusted odds ratio aOR = 1.7(1-3.3), p = 0.04) and daytime dysfunction (aOR = 1.81(1.16-2.81), p = 0.0085) increased the risk of suicidal thoughts over the one-year follow-up period in patients with TRD after adjustment on age, gender, depression, trauma, anxiety, impulsivity, current daily tobacco smoking and body mass index. Hypnotics intake is associated with a reduced risk of suicidal ideation at one-year follow-up after the same adjustments (OR = 0.73(0.56-0.95), p = 0.019). Other associations between sleep quality or circadian rhythms and suicidal ideations at either baseline or one year did not remain significant in multivariate analyses after the same adjustments. LIMITATIONS: Sleep assessments were based on self-reported questionnaires rather than objective measures. CONCLUSIONS: Daytime sleepiness and dysfunction are predictors of suicidal ideations, whereas hypnotics intake is associated with a reduced risk of suicidal ideations. Diurnal symptoms of sleep disturbances are therefore red flags to target for preventing suicide in depressed patients, and hypnotics seem efficient in preventing suicide for patients with TRD.

Effects of acupuncture on obstructive sleep apnea-hypopnea syndrome: A meta-analysis.

Our study aimed to systematically evaluate the effect of acupuncture in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS). Literature search of four Chinese databases and six English databases for studies published from the inception of each database to March 1, 2022 and identify relevant studies published in Chinese or English. Related randomized controlled trials of acupuncture for the treatment of OSAHS were included to analyze the efficacy of acupuncture. Two researchers independently reviewed all of the retrieved studies to screen for eligible studies and extract the required relevant data. Included studies were subjected to a methodological quality assessment using the Cochrane Manual 5.1.0, and to a meta-analysis using Cochrane Review Manager version 5.4. A total of 19 studies with 1365 participants were examined. Compared with the control group, the apnea-hypopnea index, lowest oxygen saturation, Epworth Sleepiness Scale, interleukin-6, tumor necrosis factor α, and nuclear factor κ-B indicators all exhibited statistically significant changes. Thus, acupuncture was effective in alleviating the state of hypoxia and sleepiness and reduced the inflammatory response and disease severity among reported patients with OSAHS. Therefore, acupuncture could be widely used in the clinical treatment of OSAHS patients as a complementary strategy and warrants further study.

Evaluation of comorbid diseases in obstructive sleep apnea syndrome.

OBJECTIVE: It is known that obstructive sleep apnea syndrome affects many systems due to hypoxemia and hypercarbia. We aimed to demonstrate with the utilization of well-standardized questionnaire tools and electrophysiological tests that cognitive impairment, depression, autonomic dysfunction, and metabolic syndrome may occur in association with obstructive sleep apnea syndrome. METHODS: The electrophysiological examination protocol of autonomic nervous system functions was performed with sympathetic skin response and R-R Interval. Patients were administered Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Montreal Cognitive Assessment, and Hamilton Depression Rating Scale by physicians in face-to-face interviews. RESULTS: This study included 148 participants, consisting of 73 patients and 75 controls. There was a statistically significant difference between the patient group and control group with regard to sympathetic skin response, R-R Interval, post-hyperventilation R-R Interval, and R-R Interval variation (p<0.001). A statistically significant difference was observed between the patient group and control group in terms of median Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Montreal Cognitive Assessment scores. It was observed that the control group achieved significantly better scores than the patient group in delayed recall (p<0.001) and language (p<0.05) categories. CONCLUSION: Obstructive sleep apnea syndrome patients should be screened for diseases, especially in the cardiovascular system, that cause serious morbidity and impair functionality such as dementia and depression. We believe that many comorbid diseases encountered in obstructive sleep apnea syndrome patients can be prevented with early diagnosis and continuous positive airway pressure treatment.

Study of the association between cannabis use and sleep disturbances in a large sample of University students.

Sleep complaints and cannabis use are common among University students and are related to detrimental effects on health. The aim of this study was to explore their association. This cross-sectional study based on the i-Share e-cohort included French students between 18 and 30 years old (n = 14,787). Frequency of cannabis use was categorized into daily, weekly, monthly, and never/rarely use. Sleep complaints were defined using four items (i.e., insomnia, sleepiness, poor sleep quality, and sleep deprivation). In the whole sample (mean age: 20.4 years, 75.5% of females), 22.7% had insomnia, 18.3% had sleepiness, 22.4% had poor sleep quality, 52.5% had sleep deprivation, and 5.8% used cannabis weekly or daily. After adjustment, the likelihood of insomnia was significantly higher by 45% in cannabis users compared to non-users. The estimates steadily increased with frequency of use, reaching a 2.0-fold higher likelihood of insomnia in daily users compared to never/rarely users. Results were similar for the other sleep complaints. These findings provide support for an association between cannabis use and sleep complaints, particularly insomnia, among University students. Though direction and causality cannot be established in this setting, these results suggest warning students and health professionals about the association between cannabis use and sleep complaints.

Fatigue and Sleep in Airline Cabin Crew: A Scoping Review.

Airline cabin crew operate in dynamic work environments that are continuously changing, from unpredictable shift work hours to travelling through multiple time zones. These likely impact cabin crews' overall health and may affect their performance on safety-related tasks. Research on this population has been limited; therefore, the aim was to summarise the relevant literature regarding fatigue, sleepiness and mental health of cabin crew. This review followed the PRISMA-ScR guidelines and conducted a systematic search utilising five databases. The initial search identified 1223 studies, and through vigorous screening processes, 27 studies were selected for this review. Over half of the selected studies focused on international or long-haul flights, and a large proportion of the sample participants were women. Findings suggested a high prevalence of fatigue and sleepiness as well as unsatisfactory sleep quality with elevated susceptibility to sleep disorders. Factors identified with health outcomes were associated with flight operations (e.g., rosters) and individual differences (e.g., age and coping strategies). Regarding mental health, cabin crews are potentially at a greater risk for depression and anxiety compared to the general public. This review draws attention to the importance of using a standardised approach, such as validated measures for fair and consistent inferences.

Effect of CPAP on cognitive function in stroke patients with obstructive sleep apnoea: a meta-analysis of randomised controlled trials.

OBJECTIVE: To investigate the effect of continuous positive airway pressure (CPAP) treatment on cognitive function in stroke patients with obstructive sleep apnoea (OSA) by exploring randomised controlled trials (RCTs). METHODS: Published RCTs that assessed the therapeutic effects of CPAP on cognition in stroke patients with OSA, compared with controls or sham CPAP, were included. Electronic databases, including MEDLINE, Embase and Cochrane library, were searched in October 2020 and October 2021. Risk of bias was assessed using the Cochrane collaboration tools. A random effects or fixed effects model was used according to heterogeneity. The outcomes were global cognitive gain, improvement in cognitive domain and subjective sleepiness. RESULTS: 7 RCTs, including 327 participants, comparing CPAP with control or sham CPAP treatment were included. 6 RCTs with 270 participants reported results related to global cognition, and CPAP treatment had no significant effects on global cognitive gain in stroke patients with OSA (standardised mean difference (SMD), 0.18; 95% CI, -0.07 to 0.42; p=0.153). A subgroup analysis showed that an early start to (<2 weeks post stroke) CPAP treatment after stroke significantly improved global cognition (SMD, 0.66; 95% CI, 0.18 to 1.14; p=0.007), which was not found in the case of a delayed start to CPAP treatment. However, CPAP did not significantly help with memory, language, attention or executive function. Moreover, CPAP therapy significantly alleviated subjective sleepiness (SMD, -0.73; 95% CI, -1.15 to -0.32; p≤0.001). CONCLUSIONS: Early initiation of CPAP treatment might contribute to improvement in global cognition in stroke patients with OSA. This study had the following limitations: the sample size in each included study was relatively small; the scales related to cognitive assessment or subjective sleepiness were inconsistent; and the methodological quality was not high. Future trials should focus on including a greater number of stroke patients with OSA undergoing CPAP treatment. PROSPERO REGISTRATION NUMBER: CRD42020214709.

Efecto a largo plazo del oxibato de sodio en la somnolencia diurna y en la estructura del sueño en pacientes con narcolepsia de tipo 1 / Long-term follow-up on the effects of sodium oxybate on daytime sleepiness and sleep architecture in patients with narcolepsy type 1

Introducción: El oxibato de sodio (SXB) se utilizó en 1979 en 16 enfermos con narcolepsia-cataplejía (NT1) que mejoraron tras 20 meses de tratamiento. Objetivos: Evaluar el efecto del SXB en la somnolencia diurna y en la estructura del sueño mediante videopolisomnografía en una muestra de 23 enfermos de NT1 (13 hombres y 10 mujeres) tratados durante tres años. Investigamos adicionalmente la presencia de comorbilidad. Pacientes y métodos: Diagnosticamos a los enfermos de acuerdo con la Clasificación Internacional de Trastornos del Sueño, tercera edición. Realizamos un estudio longitudinal, observacional y de videopolisomnografía, comparando los parámetros de sueño y los índices de apnea-hipopnea y de movimientos periódicos de las piernas de los enfermos, tratados con una dosis nocturna inicial de 4,5 g de SXB al cabo de seis meses (C-1), un año (C-2) y tres años (C-3) de tratamiento ininterrumpido.Resultados: Todos los enfermos eran HLA-DQB1*06:02 positivos, excepto un caso familiar. Trece enfermos (56%) interrumpieron el tratamiento debido a las dos tomas nocturnas, así como a la presencia de efectos secundarios, comorbilidad y embarazo. Encontramos diferencias significativas en C-2 en la estructura del sueño con aumento del estadio N2 (p < 0,03) y del índice de movimientos periódicos de las piernas (p < 0,01). En el control C-3 encontramos diferencias significativas en la estructura del sueño con aumento del estadio N1 (p = 0,03), y de los índices de movimientos periódicos de las piernas y de apnea-hipopnea. Conclusiones: El SXB se administró en dos dosis nocturnas, lo que, unido a la fragmentación del sueño y a la aparición de comorbilidades, condujo a la interrupción del tratamiento a largo plazo.(AU)

Introduction: Sodium oxybate (SXB) was administered for the first time in 1979 in 16 patients with narcolepsy with cataplexy (NT1) that improved up to 20 months. Aims: To evaluate the effect of SXB on daytime sleepiness and sleep architecture by video-polysomnography in a sample of 23 NT1 adult patients (13 men, 10 females) treated up to three years. Additional goal was to study the presence of sleep comorbidities. Patients and methods: NT1 patients were diagnosed according to International Classification of Sleep Disorders, third edition. We conducted a longitudinal observational study and a video-polysomnography comparing the sleep parameters of patients treated with an initial nocturnal dose of 4.5 g of SXB after six months (FU-1), one year (FU-2) and three years (FU-3) of uninterrupted treatment. Video-polysomnography parameters were analyzed including apnea-hypopnea and periodic leg movements indexes. Results: Patients were HLA-DQB1*06:02 positive except a familial case. Thirteen patients (56%) discontinued SXB treatment over the three-year of the study. The two-nightly doses has been one of the reason for discontinuing treatment as well as insufficient compliance, mild or severe side effects, comorbidities and pregnancy. We found significant differences at FU-2 in sleep structure with an increased in stage N2 (p < 0.03) and a higher periodic leg movements index (p < 0.01). At FU-3 we found significant differences in sleep structure with an increase in stage N1 (p = 0.03) and in comorbidities (periodic leg movements an apnea-hypopnea indexes). There was not significant change on daytime sleepiness during the study. Conclusions: SXB was administered in low-medium doses. Two-nightly doses and sleep fragmentation linked to sleep comorbidities at long-term lead to drug withdrawal.(AU)

Sleep Problems in Individuals With Intestinal Stomas and Determining the Quality of Sleep: A Multicenter Study.

PURPOSE: The aim of this study was to determine sleep problems and the sleep quality of individuals with intestinal stomas. DESIGN: Descriptive quantitative design was used. SUBJECTS AND SETTING: The research was carried out from September 2018 to September 2019 at 3 university hospitals with stoma units located in Ankara, Turkey. The study sample comprised 222 individuals with intestinal ostomies who were being monitored in these 3 centers. Approximately half (N = 113, 50.9%) had an ileostomy and 68.5% (N = 152) had a temporary stoma. More than half of the participants (N = 116, 52.3%) reported current sleep problems, 59.5% (N = 132) reported that their stoma affected their sleep, and 64% (N = 142) had problems at night due to their stomas, reporting that they woke up frequently during their main sleep period due to ostomy-related problems. METHODS: Three instruments were used to measure study outcomes: the researcher-designed instrument determining the descriptive characteristics of individuals with intestinal stomas, the Pittsburgh Sleep Quality Index, and Epworth Sleepiness Scale. RESULTS: The mean Pittsburgh Sleep Quality Index score was found to be above 5 (13.42, SD: 3.01) indicating poor sleep quality. The mean Epworth Sleepiness Scale score was 7.54 (SD: 6.37) indicating that participants had daytime sleepiness. The mean Pittsburgh Sleep Quality Index scores of participants with ileostomies ( P = .002) and those with temporary stomas ( P = .009) were found to be significantly higher. CONCLUSIONS: Study findings indicate that individuals with intestinal stomas have poor sleep quality and problems with daytime sleepiness; those with ileostomies and temporary stomas had the worst quality of sleep.

A Survey Exploring How Watch Officers Manage Effects of Sleep Restrictions during Maritime Navigation.

Merchant marine officers work shifted hours with a sometimes very tiring work/rest rhythm that can lead to sleep restrictions and increased sleepiness during navigation. The aim of this study is to assess the risk of sleep deprivation-related sleepiness during navigation and the factors contributing to this risk. A second objective is to evaluate the use and effectiveness of sleepiness countermeasures. An online quantitative survey of 43 questions was conducted on 183 French maritime officers. A total of 39.9% of the participants experienced at least occasionally severe sleepiness and 29% had fallen asleep during navigation. A total of 42.6% reported not being able to experience enough sleep on board. Sleep requirements were affected by time spent on board, area of activity, and watch system. Sleepiness was more common during monotonous than demanding sailing. Officers frequently use caffeine, as well as vigilance-enhancing activities that they consider effective, which are not yet validated, (i.e., social interactions). However, they are not inclined to seek replacements in case of severe sleepiness. Sleep deprivation is common among maritime officers and leads to the risk of severe sleepiness while operating the vessel, with few effective countermeasures available. Strategies used for sleep management and sleepiness prevention should focus more on sleep duration, safety culture, and improving countermeasures to sleepiness.

Understanding the confluence of injury and obesity in a Grade 2 obesity and above population.

OBJECTIVE: Obesity and injury are major inter-related public health challenges. The objective of this study was to explore the perceptions of injury in people with severe obesity. METHODS: A cross-sectional design was employed to capture injury perception and lifestyle habits via questionnaires. Weight (kg) and height (m) were measured by clinicians for patients attending a weight loss group program. Univariate, chi-square, ANOVA and ordinal regression analyses were undertaken. RESULTS: There were 292 participants (67.1% female), mean age 49.3 years and Body Mass Index 47.2 kg/m2 (range 30.7-91.9 kg/m2). Concern about having an injury was found in 83%, and 74.2% thought that weight would increase the likelihood of injury. A greater concern of being injured at baseline was associated with less weight loss at eight weeks (F=3.567; p=0.03). Depression, anxiety and sleepiness score were higher in those who reported greater 'Concern about having an injury'. CONCLUSIONS: People with obesity fear injury and falling, which limits their willingness to exercise. Anxiety symptoms appear to exacerbate this connection. IMPLICATIONS FOR PUBLIC HEALTH: In individuals with obesity, anxiety, sleepiness and depression are associated with a fear of being injured. Addressing fear and reducing anxiety may decrease barriers to participating in physical activity.

Motor and non-motor features in Parkinson's Disease patients carrying GBA gene mutations.

BACKGROUND: Mutations of the Glucocerebrosidase (GBA) gene are the most common genetic risk factor yet discovered for Parkinson's Disease (PD), being found in about 5-14% of Caucasian patients. OBJECTIVE: We aimed to assess motor and non-motor symptoms (NMS) in patients with GBA-related PD (GBA-PD) in comparison with idiopathic PD (iPD) subjects using standardized and validated scales. METHODS: Eleven (4 M, 7 F) patients with GBA-PD and 22 iPD patients, selected from the same cohort and matched for gender, age, and disease duration, were enrolled. The disease severity was assessed by Unified Parkinson's Disease Rating Scale-section III, gait disorder and falls by Freezing of Gait Questionnaire, and motor fluctuations by Wearing off questionnaire. NMS were evaluated using the following scales: Mini-Mental State Examination and extended neuropsychological battery, if required, Non-Motor Symptoms Scale, SCOPA-AUT Questionnaire, Apathy Evaluation Scale, Beck Depression Inventory, Epworth Sleepiness Scale, Restless Legs Syndrome Rating Scale, REM Sleep Behavior Disorder Screening Questionnaire, and Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease. RESULTS: GBA-PD patients showed a more severe and rapidly progressive disease, and more frequent positive family history for PD, akinetic-rigid phenotype, postural instability, dementia, and psychosis in comparison to iPD. Two of three subjects carrying L444P mutation presented with early dementia. We also found a higher occurrence of fatigue, diurnal sleepiness, and intolerance to heat/cold in the carriers group. CONCLUSIONS: Our results confirm that NMS and a more severe and faster disease course more frequently occur among GBA-PD patients in comparison to iPD.