Showing papers on "Epworth Sleepiness Scale published in 2021"

Measuring Subjective Sleep Quality: A Review.

Abstract: Sleep quality is an important clinical construct since it is increasingly common for people to complain about poor sleep quality and its impact on daytime functioning. Moreover, poor sleep quality can be an important symptom of many sleep and medical disorders. However, objective measures of sleep quality, such as polysomnography, are not readily available to most clinicians in their daily routine, and are expensive, time-consuming, and impractical for epidemiological and research studies., Several self-report questionnaires have, however, been developed. The present review aims to address their psychometric properties, construct validity, and factorial structure while presenting, comparing, and discussing the measurement properties of these sleep quality questionnaires. A systematic literature search, from 2008 to 2020, was performed using the electronic databases PubMed and Scopus, with predefined search terms. In total, 49 articles were analyzed from the 5734 articles found. The psychometric properties and factor structure of the following are reported: Pittsburgh Sleep Quality Index (PSQI), Athens Insomnia Scale (AIS), Insomnia Severity Index (ISI), Mini-Sleep Questionnaire (MSQ), Jenkins Sleep Scale (JSS), Leeds Sleep Evaluation Questionnaire (LSEQ), SLEEP-50 Questionnaire, and Epworth Sleepiness Scale (ESS). As the most frequently used subjective measurement of sleep quality, the PSQI reported good internal reliability and validity; however, different factorial structures were found in a variety of samples, casting doubt on the usefulness of total score in detecting poor and good sleepers. The sleep disorder scales (AIS, ISI, MSQ, JSS, LSEQ and SLEEP-50) reported good psychometric properties; nevertheless, AIS and ISI reported a variety of factorial models whereas LSEQ and SLEEP-50 appeared to be less useful for epidemiological and research settings due to the length of the questionnaires and their scoring. The MSQ and JSS seemed to be inexpensive and easy to administer, complete, and score, but further validation studies are needed. Finally, the ESS had good internal consistency and construct validity, while the main challenges were in its factorial structure, known-group difference and estimation of reliable cut-offs. Overall, the self-report questionnaires assessing sleep quality from different perspectives have good psychometric properties, with high internal consistency and test-retest reliability, as well as convergent/divergent validity with sleep, psychological, and socio-demographic variables. However, a clear definition of the factor model underlying the tools is recommended and reliable cut-off values should be indicated in order for clinicians to discriminate poor and good sleepers.

Decrease in sleep quality during COVID-19 outbreak.

Abstract: The COVID-19 outbreak witnessed in the first months of 2020 has led to unprecedented changes in society’s lifestyles. In the current study, we aimed to investigate the effect of this unexpected context on sleep. During the COVID-19 outbreak, we performed an online survey with individuals formerly recruited for validation of the Spanish version of the sleep questionnaire Satisfaction, Alertness, Timing, Efficiency, and Duration (SATED). In the current survey, we asked the participants to complete the previously answered questionnaires including the Pittsburgh Sleep Quality Index (PSQI), a modified version of the Epworth Sleepiness Scale (ESS), and the SATED questionnaire. We also assessed the mood by the Profile of Mood States (POMS) questionnaire. The 71 participants were mostly women (75%) with a mean (± SD) age of 40.7 ± 11.9 years. Comparing the previous PSQI score to that during the COVID-19 outbreak, we observed worsening sleep quality (5.45 ± 3.14 to 6.18 ± 3.03 points, p = 0.035). In parallel, there was an increase in the negative mood (p = 0.002). Accordingly, the decrease in sleep quality was substantially correlated with negative mood (p < 0.001). There were no differences in the ESS or SATED. The COVID-19 outbreak–associated events correlate with decreased sleep quality in association with an increase in negative mood. Considering the importance of sleep for a healthy life, and in particular for immune function, efforts should be made to improve awareness on this matter and to offer psychological assistance to affected individuals.

Temporal associations between morningness/eveningness, problematic social media use, psychological distress and daytime sleepiness: Mediated roles of sleep quality and insomnia among young adults.

Abstract: The extant literature has suggested relationships between an individual's chronotype (in relation to morningness/eveningness) and several outcomes, including addictive disorders, psychological distress and daytime sleepiness. Moreover, sleep quality has been proposed to be a mediator in the aforementioned relationships. Consequently, the aim of the present study was to investigate the complex relationship between morningness/eveningness, problematic social media use, psychological distress and daytime sleepiness, with the potential mediators of sleep quality and insomnia. All participants (N = 1,791 [30.1% males]; mean age = 27.2 years, SD = 10.1) completed a battery of psychometric scales, including a reduced version of the Morningness‐Eveningness Questionnaire (at baseline), the Pittsburgh Sleep Quality Index and Insomnia Severity Index (1 month after baseline assessment), the Bergen Social Media Addiction Scale, the Hospital Anxiety and Depression Scale, and the Epworth Sleepiness Scale (2 months after baseline assessment). The impacts of morningness‐eveningness on problematic social media use, anxiety, depression and daytime sleepiness were found in the mediation models. Furthermore, the mediated effects of insomnia and sleep quality were observed. The present study's results emphasize the importance of promoting healthy sleep habits and sleep hygiene behaviours, and that of early detection of sleep problems among individuals who have the eveningness chronotype, because this would significantly improve their health outcomes.

Progression of sleep disturbances in Parkinson’s disease: a 5-year longitudinal study

Abstract: Sleep disorders can occur in early Parkinson’s disease (PD). However, the relationship between different sleep disturbances and their longitudinal evolution has not been fully explored. To describe the frequency, coexistence, and longitudinal change in excessive daytime sleepiness (EDS), insomnia, and probable REM sleep behavior disorder (pRBD) in early PD. Data were obtained from the Parkinson’s Progression Markers Initiative (PPMI). EDS, insomnia, and pRBD were defined using the Epworth Sleepiness Scale, MDS-UPDRS Part I sub-item 1.7, and RBD screening questionnaire. 218 PD subjects and 102 controls completed 5 years of follow-up. At baseline, 69 (31.7%) PD subjects reported one type of sleep disturbance, 25 (11.5%) reported two types of sleep disturbances, and three (1.4%) reported all three types of sleep disturbances. At 5 years, the number of PD subjects reporting one, two, and three types of sleep disturbances was 85 (39.0%), 51 (23.4%), and 16 (7.3%), respectively. Only 41(18.8%) patients were taking sleep medications. The largest increase in frequency was seen in insomnia (44.5%), followed by EDS (32.1%) and pRBD (31.2%). Insomnia was the most common sleep problem at any time over the 5-year follow-up. The frequency of sleep disturbances in HCs remained stable. There is a progressive increase in the frequency of sleep disturbances in PD, with the number of subjects reporting multiple sleep disturbances increasing over time. Relatively a few patients reported multiple sleep disturbances, suggesting that they can have different pathogenesis. A large number of patients were not treated for their sleep disturbances.

Risk factors of excessive daytime sleepiness in a prospective population-based cohort.

Abstract: Although excessive daytime sleepiness is commonly evaluated in clinical and research settings using the Epworth Sleepiness Scale, few studies have assessed the factors associated with its incidence in the general population. We prospectively investigated the predictors of incident and persistent excessive daytime sleepiness in 2,751 subjects (46.1% men, mean age 56.0 ± 9.8 years) from the CoLaus-PsyCoLaus population-based cohort (Lausanne, Switzerland) over 5 years. Participants completed the Epworth Sleepiness Scale and the Pittsburgh Sleep Quality Index, and underwent a full clinical evaluation at baseline and 5 years afterwards. Ambulatory polysomnography was performed at baseline in a sub-sample of 1,404 subjects. Among the 2,438 subjects without excessive daytime sleepiness (Epworth Sleepiness Scale ≤ 10) at baseline, the 5-year incidence of excessive daytime sleepiness was 5.1% (n = 124). Multivariate logistic regression revealed that male sex, depressive symptoms, reported poor sleep quality and moderate to severe obstructive sleep apnea were independent predictors of incident excessive daytime sleepiness, while older age, moderate coffee consumption, periodic leg movement during sleep and hypertension were independent protective factors. Stratified analysis according to sex and age showed some distinctive associations. Among the 313 patients with excessive daytime sleepiness at baseline, 137 (43.8%) had persistent excessive daytime sleepiness 5 years later. Our findings provide new insights into the predictors of incident excessive daytime sleepiness, but interventional studies are needed to understand the impact of treating these risk factors on the incidence of excessive daytime sleepiness.

Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes

Abstract: Background The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remedē System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant. Methods Patients remaining in the Pivotal Trial at the time of FDA approval were invited to enroll in the PAS and consented to undergo sleep studies (scored by a central laboratory), complete the Epworth Sleepiness Scale (ESS) questionnaire to assess daytime sleepiness, and safety assessment. All subjects (treatment and former control group) receiving active therapy were pooled; data from both trials were combined for analysis. Results Fifty-three of the original 151 Pivotal Trial patients consented to participate in the PAS and 52 completed the 5-year visit. Following TPNS therapy, the apnea-hypopnea index (AHI), central-apnea index (CAI), arousal index, oxygen desaturation index, and sleep architecture showed sustained improvements. Comparing 5 years to baseline, AHI and CAI decreased significantly (AHI baseline median 46 events/hour vs 17 at 5 years; CAI baseline median 23 events/hour vs 1 at 5 years), though residual hypopneas were present. In parallel, the arousal index, oxygen desaturation index and sleep architecture improved. The ESS improved by a statistically significant median reduction of 3 points at 5 years. Serious adverse events related to implant procedure, device or delivered therapy were reported by 14% of patients which include 16 (9%) patients who underwent a pulse generator reposition or lead revision (primarily in the first year). None of the events caused long-term harm. No unanticipated adverse device effects or related deaths occurred through 5 years. Conclusion Long-term TPNS safely improves CSA, sleep architecture and daytime sleepiness through 5 years post implant. Clinical trial registration ClinicalTrials.gov Identifier: NCT01816776.

Effects of Exercise on Sleep Quality and Insomnia in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Abstract: Study Objectives: We conducted a meta-analysis to assess the effects of different regular exercise (lasting at least 2 months on a regular basis) on self-reported and physiological sleep quality in adults. Varied exercise interventions contained traditional physical exercise (e.g., walking, cycling) and mind-body exercise characterized by gentle exercise with coordination of the body (e.g., yoga). Methods: Procedures followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Systematical searches were conducted in three electronic databases (PubMed, Embase, and Web of Science) for relevant research that involved adult participants without pathological diseases receiving exercise intervention. The search strategy was based on the population, intervention, comparison, and outcome study design (PICOS) framework. The self-reported outcomes included varied rating scales of Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Epworth Sleepiness Scale (ESS). Subgroup meta-analyses of PSQI scores were conducted based on type of exercise, duration of intervention, and participants' age and gender. The physiological outcomes were measured by Actigraph. All meta-analyses were performed in a fixed or random statistic model using Revman software. Results: Twenty-two randomized controlled trials were included in the analysis. The overall analysis on subjective outcomes suggests that exercise interventions significantly improved sleep quality in adults compared with control interventions with lower PSQI (MD -2.19; 95% CI -2.96 to -1.41), ISI (MD -1.52; 95% CI -2.63 to -0.41), and ESS (MD -2.55; 95% CI -3.32 to -1.78) scores. Subgroup analyses of PSQI scores showed both physical and mind-body exercise interventions resulted in improvements of subjective sleep to the same extent. Interestingly, short-term interventions (≤3 months) had a significantly greater reduction in sleep disturbance vs. long-term interventions (>3 months). Regarding physiological sleep, few significant effects were found in various sleep parameters except the increased sleep efficiency in the exercise group vs. control group. Conclusions: Results of this systematic review suggest that regular physical as well as mind-body exercise primarily improved subjective sleep quality rather than physiological sleep quality in adults. Specifically, self-reported sleep quality, insomnia severity, and daytime sleepiness could be improved or ameliorated with treatment of exercise, respectively, evaluated by PSQI, ISI, and ESS sleep rating scales.

The Effect of Adenotonsillectomy on Children's Behavior and Cognitive Performance with Obstructive Sleep Apnea Syndrome: State of the Art.

Abstract: (1) Background: This systematic review was designed to analyze adenotonsillectomy’s role in treating behavioural disorders and sleep-related quality of life in pediatric OSAS. (2) Methods: Papers that report pre-operative and post-operative outcomes by using the Epworth sleepiness scale, OSA-18, NEPSY, Conners’ rating scale, BRIEF, PSQ-SRBD, PedsQL and CBCL. We performed a comprehensive review of English papers published during the last 20 years regarding behavioural disorders in OSAS patients and adenotonsillectomy. (3) Results: We included 11 studies reporting behavioral outcomes and sleep related quality of life after surgery. We investigated changes in behavior and cognitive outcomes after AT, and we found significant improvements of the scores post-AT in almost all studies. After comparing the AT group and control group, only one study had no difference that reached significance at one year post-AT. In another study, it did not show any significant improvement in terms of all behavioural and cognitive outcomes. The questionnaires on sleep-related quality of life after AT (PSQ-SRBD or ESS or OSA-18 or KOSA) may improve with positive changes in sleep parameters (AHI, ODI and SpO2). Furthermore, there is a significantly higher decrease in OSAS symptoms than the pre-AT baseline score. (4) Conclusion: Future studies should pay more attention to characterizing patient populations as well as rapid surgical treatments through existing criteria.

Sleepiness, sleep deprivation, quality of life, mental symptoms and perception of academic environment in medical students

Abstract: It has been previously shown that a high percentage of medical students have sleep problems that interfere with academic performance and mental health. To study the impact of sleep quality, daytime somnolence, and sleep deprivation on medical students, we analyzed data from a multicenter study with medical students in Brazil (22 medical schools, 1350 randomized medical students). We applied questionnaires of daytime sleepiness, quality of sleep, quality of life, anxiety and depression symptoms and perception of educational environment. 37.8% of medical students presented mild values of daytime sleepiness (Epworth Sleepiness Scale - ESS) and 8.7% presented moderate/severe values. The percentage of female medical students that presented ESS values high or very high was significantly greater than male medical students (p < 0.05). Students with lower ESS scores presented significantly greater scores of quality of life and perception of educational environment and lower scores of depression and anxiety symptoms, and these relationships showed a dose-effect pattern. Medical students reporting more sleep deprivation showed significantly greater odds ratios of presenting anxiety and depression symptoms and lower odds of good quality of life or perception of educational environment. There is a significant association between sleep deprivation and daytime sleepiness with the perception of quality of life and educational environment in medical students.

Sleep quality among parents and their children during COVID-19 pandemic in a Southern - Brazilian sample.

Abstract: OBJECTIVE: To evaluate sleep characteristics of parents and their children during the COVID-19 pandemic and predictors for sleep disturbances. METHODS: Cross-sectional web-based study using an online survey made available for dyads of parents and their children during the 7th week of quarantine in southern Brazil. Parents' and adolescents' sleep were characterized using the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale. For children aged 0-3 years parents completed the Brief Infant Sleep Questionnaire, for those aged 4-12 years the Sleep Disturbance Scale for Children. Parents also informed, subjectively, their perception about sleep habits during social distancing. Multiple regression was run to predict sleep disturbances in adults using independent variables: sex, income, education, children age, and children with sleep disturbances. RESULTS: Data from 577 dyads showed sleep alterations in 69,8% of adults, in 58,6% of children aged 0-3 years, 33,9% in the 4-12 years range (with a predominance of disorders of initiating or maintaining sleep), and 56,6% in adolescents. Sex (female) and children with sleep disturbances were significant predictors of a sleep problem in parents (p < 0.005). Subjective perception revealed complaints related to emotional concerns such as anxiety and fear in adults and due to alterations in routine in children and adolescents. CONCLUSION: The present study's data showed an increased rate of sleep problems among families during quarantine both measured by validated instruments and also based on personal perception.

The Top End Sleepiness Scale (TESS): A New Tool to Assess Subjective Daytime Sleepiness Among Indigenous Australian Adults.

Abstract: Purpose To illustrate the utility of a newly developed culturally safe and clinically relevant subjective daytime sleepiness assessment tool "Top End Sleepiness Scale" (TESS) for use among Indigenous Australians. Patients and methods The TESS questionnaire consists of pictorial representations of 6 items representing daily activities that would induce daytime sleepiness specific for Indigenous Australians living in the regional and remote Australia. Consecutive adult Indigenous patients who consented to pilot the TESS questionnaire prior to undergoing a diagnostic polysomnography (PSG) at the Top End Health Service region, Northern Territory of Australia were assessed. The TESS questionnaire was evaluated for its correlation in predicting obstructive sleep apnea (OSA) according to apnea-hypopnea index. Results Eighty-two patients were included. The majority (70%) had moderate to severe OSA (AHI ≥15). Patients were aged in their mid-40's (45.47 95% CI (42.9, 48.05)) with a tendency to obesity (median BMI 33.67 IQR 30.86, 38.95) and a high prevalence of chronic conditions (72%) (hypertension, diabetes or heart disease). The TESS showed high internal consistency (Split half Spearman correlation=0.71, Cronbach's α =0.81), and a cut-off value ≥3 resulted in sensitivity 84%, specificity 38%. Comparison of area under the curve for TESS to Epworth Sleepiness Scale (ESS) in this sample showed the TESS to have greater sensitivity and specificity overall, which approached significance (p=0.072) when cut-off values of ≥3 and ≥8 (TESS & ESS respectively) were used. The sensitivity and specificity for TESS was also comparable to the other currently used questionnaires, such as the Berlin Questionnaire, STOP-BANG and OSA 50. Conclusion Currently, there are no subjective daytime sleepiness assessment toll available specifically for Indigenous population. The proposed TESS sleepiness screening tool represented in this study can potentially complement or adopted alongside other existing questionnaire, which may offer greater utility in the assessment of sleep disorders among Indigenous people.

Characteristics associated with hypersomnia and excessive daytime sleepiness identified by extended polysomnography recording.

Abstract: Study objectives Hypersomnolence, defined by excessive daytime sleepiness (EDS) or excessive quantity of sleep (EQS), has been associated with increased morbidity. The aim of this study was to determine the clinical and polysomnographic characteristics associated with EQS and EDS assessed objectively during extended polysomnography recording. Methods A total of 266 drug-free subjects (201 women; mean age: 26.5 years [16.08; 60.87]) underwent 32-h bed-rest polysomnography recording preceded by polysomnography and modified multiple sleep latency test (mMSLT). Participants were categorized according to their total sleep time (bed-rest TST ≥19 h, hypersomnia), objective EDS (mean sleep latency on MSLT ≤8 min), and self-reported EDS (Epworth sleepiness scale score >10) and EQS (≥9 h/24 h per week). Results Subjects with hypersomnia were often younger, with normal sleep architecture, high nighttime sleep efficiency, and severe objective EDS. No association with sex, body mass index, Epworth sleepiness scale, EQS, and depressive symptoms was detected. Subjects with objective EDS had less EQS, higher sleep efficiency, and increased hypersomnia. Discrepancies were observed between objective and self-reported measures of sleep duration and EDS. Finally, 71 subjects were identified who had objective hypersomnia and/or EDS, no medical and psychiatric conditions and normal polysomnography parameters, and therefore met the stringent criteria of idiopathic hypersomnia, an orphan disorder. Conclusions Sleep duration and EDS should be quantified using self-reported and objective measures in a controlled procedure to differentiate long sleepers, patients with hypersomnia, and patients with idiopathic hypersomnia. This will help to better understand their biology, to identify specific biomarkers, and to assess related health outcomes.

Effect of Upper Airway Stimulation in Patients with Obstructive Sleep Apnea (EFFECT): A Randomized Controlled Crossover Trial.

Abstract: Background: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. Methods: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. Results: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was −15.5 (95% CI −18.3 to −12.8), for ESS it was −3.3 (95% CI −4.4 to −2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. Conclusions: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

DUOGLOBE: One-Year Outcomes in a Real-World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease.

Abstract: Background Levodopa-carbidopa intestinal gel (LCIG) is an established treatment for improving motor and some non-motor symptoms (NMS) in patients with advanced Parkinson's disease (PD). Prospective long-term data in routine clinical practice are limited. Objective Assess LCIG effectiveness and safety in patients with advanced PD after 12 months during real-world routine clinical practice. Methods Duodopa/Duopa in patients with advanced Parkinson's disease-a global observational study evaluating long-term effectiveness (DUOGLOBE) (NCT02611713) is an ongoing, prospective, multinational, observational study of LCIG-naive patients treated as part of routine clinical practice; 3 years of follow-up are planned. The primary outcome is the change in patient-reported off time. Other assessments include the Unified Dyskinesia Rating Scale (UDysRS), Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Sleep scale (PDSS-2), Epworth Sleepiness Scale (ESS), health-related quality of life (HR-QoL), caregiver burden, and serious adverse events (SAEs). Outcomes from baseline to month (M) 12 are presented. Results In this 12-month follow-up, patients (N = 195) had baseline characteristics similar to other LCIG studies. Significant improvements (mean change to M12) were observed in off time (-3.9 ± 3.6 hr/day, P Conclusions These 12-month outcome data show sustained, long-term improvements and support the real-world effectiveness of LCIG in patients with advanced PD. Safety was consistent with previous studies.

Once-Nightly Sodium Oxybate (FT218) Demonstrated Improvement of Symptoms in a Phase 3 Randomized Clinical Trial in Patients With Narcolepsy.

Abstract: STUDY OBJECTIVES To assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial. METHODS Narcolepsy patients aged ≥16 years were randomized 1:1 to uptitration of ON-SXB (4.5, 6, 7.5, and 9 g) or placebo. Three coprimary endpoints were change from baseline in mean sleep latency on the Maintenance of Wakefulness test, Clinical Global Impression-Improvement rating, and weekly cataplexy attacks at 9, 7.5, and 6 g. Secondary endpoints included change from baseline on the Epworth Sleepiness Scale. Safety included adverse drug reactions and clinical laboratory assessments. RESULTS In total, 222 patients were randomized; 212 received ≥1 dose of ON-SXB (n=107) or placebo (n=105). For the 3 coprimary endpoints and Epworth Sleepiness Scale, all 3 doses of ON-SXB demonstrated clinically meaningful, statistically significant improvement vs placebo (all P<0.001). For ON-SXB 9 g vs placebo, increase in mean sleep latency was 10.8 vs 4.7 min (LSMD [95% CI], 6.13 [3.52-8.75]), 72.0% vs 31.6% were rated much/very much improved on Clinical Global Impression-Improvement (OR [95% CI], 5.56 [2.76-11.23]), change in mean weekly number of cataplexy attacks was -11.5 vs -4.9 (LSMD [95% CI], -6.65 [-9.32 to -3.98]), and change in Epworth Sleepiness Scale was -6.5 and -2.7 (LSMD [95% CI], -6.52 [-5.47 to -2.26]). Common adverse reactions included nausea, vomiting, headache, dizziness, and enuresis. CONCLUSIONS ON-SXB significantly improved narcolepsy symptoms; its safety profile was consistent with SXB. ON-SXB conferred efficacy with a clearly beneficial single nighttime dose.

Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives

Abstract: Excessive sleepiness (ES) is a symptom of obstructive sleep apnea (OSA) and narcolepsy that has severe consequences. Wake-promoting drugs and stimulants are utilized as accessory treatment in OSA to reduce propensity to sleep but they do not improve sleep-disordered breathing. Solriamfetol is a first-line therapeutic agent to combat sleepiness in OSA and narcolepsy patients that is approved both by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For excessively sleepy adult patients with OSA despite primary treatment or narcolepsy patients without cataplexy, solriamfetol may be used as initial therapy or as replacement therapy in patients who fail treatment or experience unacceptable side effects with modafinil, armodafinil, pitolisant, or stimulants. It can also be used as add-on therapy in OSA or narcolepsy patients when ES is only partially controlled with modafinil, armodafinil, pitolisant, sodium oxybate, or stimulants. Solriamfetol is a phenylalanine derivative whose wake-promoting action may be mediated through its selective dopamine and norepinephrine reuptake inhibition. This paper reviews the profile of solriamfetol in treating ES associated with OSA or narcolepsy and discusses patient selection and clinical perspectives. Mechanism of action, pharmacology, pharmacokinetics, clinical efficacy, and tolerability of solriamfetol are described. The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) solriamfetol trials demonstrated the efficacy of solriamfetol in reducing propensity to sleep and maintaining wakefulness, with significant improvements in mean maintenance of wakefulness test (MWT) sleep latencies and significant reduction in Epworth Sleepiness Scale (ESS) scores compared to placebo. With solriamfetol, significantly higher percentages of patients showed improvement in patient's and clinician's global impression of change.

Effects of telemedicine interventions in improving continuous positive airway pressure adherence in patients with obstructive sleep apnoea: a meta-analysis of randomised controlled trials.

Abstract: This meta-analysis was conducted to assess the effects of telemedicine interventions on continuous positive airway pressure (CPAP) adherence in patients with obstructive sleep apnoea (OSA). The PubMed, Cochrane Library, OVID, Web of Science and EBSCO host databases were searched from January 2004 to February 2020 for randomised controlled trials (RCTs) that assessed the effects of telemedicine interventions on CPAP adherence in patients with OSA. The study inclusion criteria were RCTs that compared patients who received telemedicine interventions with a control group and reported a change in CPAP adherence. The primary outcome was the improvement in CPAP adherence. In total, there were 11 RCTs (n = 1358) with quantitative analyses. Intervention times ranged from 1 to 6 months. Compared to controls, the telemedicine group exhibited better adherence to CPAP therapy (pooled mean difference (MD) = 0.57, 95% CI = 0.33 to 0.80, I2 = 7%, p < 0.00001). We performed sensitivity analyses by the type of telemedicine intervention, comorbidity burden, and OSA severity to explore whether or not their effect sizes may have affected the time of CPAP application. We performed subgroup analyses by follow-up duration, age, and OSA Epworth sleepiness scale (ESS) symptoms to determine if their effect sizes may have affected the time of CPAP application. However, these analyses did not change the statistical significance of the pooled estimate. The use of telemedicine for up to 6 months may enhance CPAP adherence in patients with OSA, when compared to no intervention. Our study was searched from January 2004 to February 2020 for randomised controlled trials (RCTs) that assessed the effects of telemedicine interventions on CPAP adherence in patients with OSA. Future studies can continue to search for articles after February 2020

Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring in Individuals with Primary Snoring and Mild Obstructive Sleep Apnea

Abstract: Study Objectives: Evaluating daytime neuromuscular electrical training (NMES) of tongue muscles in individuals with Primary Snoring and Mild Obstructive Sleep Apnea (OSA). Methods: A multicenter prospective study was undertaken in patients with primary snoring and mild sleep apnea where daytime NMES (eXciteOSA® Signifier Medical Technologies Ltd., London W6 0LG, UK) was used for 20 min once daily for 6 weeks. Change in percentage time spent snoring was analyzed using a two-night sleep study before and after therapy. Participants and their bed partners completed sleep quality questionnaires: Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), and the bed partners reported on the nighttime snoring using a Visual Analogue Scale (VAS). Results: Of 125 patients recruited, 115 patients completed the trial. Ninety percent of the study population had some reduction in objective snoring with the mean reduction in the study population of 41% (p < 0.001). Bed partner-reported snoring reduced significantly by 39% (p < 0.001). ESS and total PSQI scores reduced significantly (p < 0.001) as well as bed partner PSQI (p = 0.017). No serious adverse events were reported. Conclusions: Daytime NMES (eXciteOSA®) is demonstrated to be effective at reducing objective and subjective snoring. It is associated with effective improvement in patient and bed partner sleep quality and patient daytime somnolence. Both objective and subjective measures demonstrated a consistent improvement. Daytime NMES was well tolerated and had minimal transient side effects.

Electrical stimulation as a therapeutic approach in obstructive sleep apnea — a meta-analysis

Abstract: Electrical stimulation of the upper airway dilator muscles is an emerging treatment for obstructive sleep apnea (OSA). Invasive hypoglossal nerve stimulation (HNS) has been accepted as treatment alternative to continuous positive airway pressure (CPAP) for selected patients, while transcutaneous electrical stimulation (TES) of the upper airway is being investigated as non-invasive alternative. A meta-analysis (CRD42017074674) on the effects of both HNS and TES on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS) in OSA was conducted including published evidence up to May 2018. Random-effects models were used. Heterogeneity and between-study variance were assessed by I2 and τ2, respectively. Of 41 identified clinical trials, 20 interventional trials (n = 895) could be pooled in a meta-analysis (15 HNS [n = 808], 5 TES [n = 87]). Middle-aged (mean ± SD 56.9 ± 5.5 years) and overweight (body mass index 29.1 ± 1.5 kg/m2) patients with severe OSA (AHI 37.5 ± 7.0/h) were followed-up for 6.9 ± 4.0 months (HNS) and 0.2 ± 0.4 months (TES), respectively. The AHI improved by − 24.9 h−1 [95%CI − 28.5, − 21.2] in HNS (χ2 79%, I2 82%) and by − 16.5 h−1 [95%CI − 25.1, − 7.8] in TES (χ2 7%, I2 43%; both p < 0.001). The ESS was reduced by − 5.0 (95%CI − 5.9, − 4.1) (p < 0.001). Both invasive and transcutaneous electrical stimulation reduce OSA severity by a clinically relevant margin. HNS results in a clinically relevant improvement of symptoms. While HNS represents an invasive treatment for selected patients with moderate to severe OSA, TES should be further investigated as potential non-invasive approach for OSA.

Psychological profile and unexpected pain in oral lichen planus: A case–control multicenter SIPMO studya

Abstract: OBJECTIVES To analyze psychological profiles, pain, and oral symptoms in patients with oral lichen planus (OLP). MATERIALS AND METHODS 300 patients with keratotic OLP (K-OLP; reticular, papular, plaque-like subtypes), 300 patients with predominant non-keratotic OLP (nK-OLP; erythematosus atrophic, erosive, ulcerative, bullous subtypes), and 300 controls were recruited in 15 universities. The number of oral sites involved and oral symptoms were recorded. The Numeric Rating Scale (NRS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression and for Anxiety (HAM-D and HAM-A), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS) were administered. RESULTS The OLP patients, especially the nK-OLP, showed higher scores in the NRS, T-PRI, HAM-D, HAM-A and PSQI compared with the controls (p-value < .001** ). A positive correlation between the NRS, T-PRI, HAM-A, HAM-D, and PSQI was found with the number of oral symptoms and number of oral sites involved. Pain was reported in 67.3% of nK-OLP and 49.7% of K-OLP cases with poor correspondence between the site of lesions and the site of the symptoms. CONCLUSIONS Mood disorders are frequently associated with OLP with an unexpected symptomatology correlated with the number of oral symptoms and with the extension of disease suggesting a peripheral neuropathy.

Relationship between sleep efficacy endpoints and measures of functional status and health-related quality of life in participants with narcolepsy or obstructive sleep apnea treated for excessive daytime sleepiness.

Abstract: This study examined the correlation between improvements in excessive daytime sleepiness in participants with obstructive sleep apnea or narcolepsy and changes in functional status, work productivity and health-related quality of life. Data from two 12-week randomized controlled trials of solriamfetol were analyzed. Participants completed the Epworth Sleepiness Scale, 10-item Functional Outcomes of Sleep Questionnaire, Work Productivity and Activity Impairment questionnaire and 36-Item Short Form Health Survey and performed the Maintenance of Wakefulness Test at baseline and weeks 4, 8 and 12. Patient Global Impression of Change was assessed at weeks 4, 8 and 12. Pearson correlations were calculated for change in scores from baseline to week 12. For both studies, changes in the 10-item Functional Outcomes of Sleep Questionnaire were highly correlated (absolute value >0.5) with changes in Epworth Sleepiness Scale scores; changes in multiple domain scores of the 36-Item Short Form Health Survey and Work Productivity and Activity Impairment questionnaire were moderately correlated (0.3-0.5) with changes in Epworth Sleepiness Scale scores in both studies and highly correlated for participants with narcolepsy. Changes in Maintenance of Wakefulness Test scores correlated moderately with changes in Epworth Sleepiness Scale scores in both studies. At week 12, Patient Global Impression of Change ratings correlated highly with Epworth Sleepiness Scale and 10-item Functional Outcomes of Sleep Questionnaire scores for both disorders. Other correlations were low. Self-reported assessments of sleepiness and global improvement appear to be more strongly correlated with measures of functioning and health-related quality of life than objectively assessed sleepiness.

Disorders of sleep and wakefulness in amyotrophic lateral sclerosis (ALS): a systematic review

Abstract: Disorders of sleep and wakefulness are common among neurodegenerative diseases. While amyotrophic lateral sclerosis (ALS) predominately manifests as motor symptoms, there is emerging evidence that disruptions to sleep and wakefulness also occur. This systematic review aims to report the most common disorders of sleep and wakefulness in ALS. We conducted a qualitative systematic review as per PRISMA guidelines and searched literature assessing the association between disorders of sleep and wakefulness with ALS using the PubMed and Medline database. Overall, 50-63% of patients with ALS have poor sleep quality as reported using the Pittsburgh Sleep Quality Index Questionnaire (PSQI). A higher proportion of ALS patients are categorized as poor sleepers, however there is conflicting evidence as to whether patients with ALS are more likely to exhibit excessive daytime sleepiness. Of the studies that utilized polysomnography, all reported various degrees of impairment to sleep microstructure and architecture among ALS patients. In future, longitudinal clinical studies will be essential for establishing the significance of impaired sleep in ALS. Future studies are also needed to establish whether the self-reported measures of poor sleep and impairment to sleep architecture occurs as a direct consequence of the disease, whether they are an early manifestation of the disease, and/or if they contribute to the neurodegenerative process.