Showing papers on "Epworth Sleepiness Scale published in 2022"

Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study

Abstract: Background Idiopathic hypersomnia is a central hypersomnolence disorder mainly characterised by excessive daytime sleepiness, with prolonged night-time sleep and pronounced sleep inertia. Until August, 2021, no medication had regulatory approval for the treatment of idiopathic hypersomnia. This study aimed to evaluate the safety and efficacy of lower-sodium oxybate in idiopathic hypersomnia. Methods This was a phase 3, multicentre (50 specialist sleep centres; six EU countries and the USA), placebo-controlled, double-blind, randomised withdrawal study. Participants (aged 18–75 years) with idiopathic hypersomnia (meeting criteria from the International Classification of Sleep Disorders, 2nd or 3rd editions) began lower-sodium oxybate treatment (oral solution once or twice nightly) in an open-label titration and optimisation period (10–14 weeks), followed by a 2-week, open-label, stable-dose period. After these open-label periods, participants were randomised (1:1) by means of an interactive web recognition system, stratified by participants’ baseline medication use, to either placebo or lower-sodium oxybate (individually optimised dose; range 2·5–9·0 g/night) during a 2-week, double-blind, randomised withdrawal period. To maintain masking of treatment assignment, placebo and lower-sodium oxybate oral solutions were matched in volume, appearance, and taste. During the double-blind, randomised withdrawal period, participants and investigators were unaware of treatment assignments. The primary efficacy endpoint was change in Epworth Sleepiness Scale (ESS) score from the end of the stable-dose period to the end of the double-blind, randomised withdrawal period, which was assessed in the modified intention-to-treat population (defined as all participants who were randomly assigned, took at least one dose of study medication during the double blind, randomised withdrawal period, and had at least one set of post-randomisation assessments for the primary or key secondary endpoints). Adverse events were assessed in the safety population (defined as all participants who took at least one dose of study medication). This study is registered at ClinicalTrials.gov, NCT03533114, and at EU Clinical Trials, 2018-001311-79, and is complete. Findings Between Nov 27, 2018, and March 6, 2020, 154 participants were enrolled and comprised the safety population. ESS scores decreased from a mean of 15·7 (SD 3·8) at baseline to 6·1 (4·0) by the end of the stable-dose period. After the open-label periods, 115 participants were randomly assigned either placebo (n=59) or lower-sodium oxybate (n=56) and comprised the modified intention-to-treat population. During the double-blind, randomised withdrawal period, ESS scores increased (worsened) in participants randomly assigned to placebo but remained stable in those assigned to lower-sodium oxybate (least squares mean difference −6·5; 95% CI −8·0 to −5·0; p<0·0001). Treatment-emergent adverse events included nausea (34 [22%] of 154), headache (27 [18%] of 154), dizziness (19 [12%] of 154), anxiety (17 [11%] 154), and vomiting (17 [11%] 154). No deaths were reported during the study. Interpretation Lower-sodium oxybate treatment resulted in a clinically meaningful improvement in idiopathic hypersomnia symptoms, with an overall safety profile consistent with that reported for narcolepsy. Lower-sodium oxybate was approved in August, 2021, by the US Food and Drug Administration for the treatment of idiopathic hypersomnia in adults. Funding Jazz Pharmaceuticals. Idiopathic hypersomnia is a central hypersomnolence disorder mainly characterised by excessive daytime sleepiness, with prolonged night-time sleep and pronounced sleep inertia. Until August, 2021, no medication had regulatory approval for the treatment of idiopathic hypersomnia. This study aimed to evaluate the safety and efficacy of lower-sodium oxybate in idiopathic hypersomnia. This was a phase 3, multicentre (50 specialist sleep centres; six EU countries and the USA), placebo-controlled, double-blind, randomised withdrawal study. Participants (aged 18–75 years) with idiopathic hypersomnia (meeting criteria from the International Classification of Sleep Disorders, 2nd or 3rd editions) began lower-sodium oxybate treatment (oral solution once or twice nightly) in an open-label titration and optimisation period (10–14 weeks), followed by a 2-week, open-label, stable-dose period. After these open-label periods, participants were randomised (1:1) by means of an interactive web recognition system, stratified by participants’ baseline medication use, to either placebo or lower-sodium oxybate (individually optimised dose; range 2·5–9·0 g/night) during a 2-week, double-blind, randomised withdrawal period. To maintain masking of treatment assignment, placebo and lower-sodium oxybate oral solutions were matched in volume, appearance, and taste. During the double-blind, randomised withdrawal period, participants and investigators were unaware of treatment assignments. The primary efficacy endpoint was change in Epworth Sleepiness Scale (ESS) score from the end of the stable-dose period to the end of the double-blind, randomised withdrawal period, which was assessed in the modified intention-to-treat population (defined as all participants who were randomly assigned, took at least one dose of study medication during the double blind, randomised withdrawal period, and had at least one set of post-randomisation assessments for the primary or key secondary endpoints). Adverse events were assessed in the safety population (defined as all participants who took at least one dose of study medication). This study is registered at ClinicalTrials.gov, NCT03533114, and at EU Clinical Trials, 2018-001311-79, and is complete. Between Nov 27, 2018, and March 6, 2020, 154 participants were enrolled and comprised the safety population. ESS scores decreased from a mean of 15·7 (SD 3·8) at baseline to 6·1 (4·0) by the end of the stable-dose period. After the open-label periods, 115 participants were randomly assigned either placebo (n=59) or lower-sodium oxybate (n=56) and comprised the modified intention-to-treat population. During the double-blind, randomised withdrawal period, ESS scores increased (worsened) in participants randomly assigned to placebo but remained stable in those assigned to lower-sodium oxybate (least squares mean difference −6·5; 95% CI −8·0 to −5·0; p<0·0001). Treatment-emergent adverse events included nausea (34 [22%] of 154), headache (27 [18%] of 154), dizziness (19 [12%] of 154), anxiety (17 [11%] 154), and vomiting (17 [11%] 154). No deaths were reported during the study. Lower-sodium oxybate treatment resulted in a clinically meaningful improvement in idiopathic hypersomnia symptoms, with an overall safety profile consistent with that reported for narcolepsy. Lower-sodium oxybate was approved in August, 2021, by the US Food and Drug Administration for the treatment of idiopathic hypersomnia in adults.

Sleep quality among parents and their children during COVID-19 pandemic

Abstract: To evaluate sleep characteristics of parents and their children during the COVID-19 pandemic and predictors for sleep disturbances.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.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.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.

Cardiovascular Benefit of Continuous Positive Airway Pressure in Adults with Coronary Artery Disease and Obstructive Sleep Apnea without Excessive Sleepiness

Abstract: Rationale: Randomized controlled trials of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) have not demonstrated protection against adverse cardiovascular outcomes. Recently, observational studies revealed that OSA-related cardiovascular risk is concentrated in patients with an elevated pulse rate response to respiratory events (ΔHR). Objectives: Here, in this post hoc analysis of a prospective clinical trial, we test the hypothesis that a greater pretreatment ΔHR is associated with greater CPAP-related protection against adverse cardiovascular outcomes. Methods: ΔHR was measured from baseline polysomnography of the RICCADSA (Randomized Intervention with CPAP in CAD and OSA) randomized controlled trial (patients with coronary artery disease [CAD] and OSA [apnea-hypopnea index ⩾ 15 events/h] with Epworth Sleepiness Scale score < 10; nCPAP:ncontrol = 113:113; male, 85%; age, 66 ± 8 [mean ± SD] yr). The primary outcome was a composite of repeat revascularization, myocardial infarction, stroke, and cardiovascular mortality. Multivariable Cox regression assessed whether the effect of CPAP was moderated by ΔHR (treatment-by-ΔHR interaction). Measurements and Main Results: The CPAP-related reduction in risk increased progressively with increasing pretreatment ΔHR (interaction hazard ratio [95% confidence interval], 0.49 [0.27 to 0.90] per SD increase in ΔHR; P < 0.05). This means that in patients with a ΔHR of 1 SD above the mean (i.e., 10 beats/min), CPAP was estimated to reduce cardiovascular risk by 59% (6% to 82%) (P < 0.05), but no significant risk reduction was estimated in patients with a mean ΔHR (6 beats/min; CPAP risk reduction, 16% [-53% to 54%]; P = 0.6). Conclusions: The protective effect of CPAP in patients with CAD and OSA without excessive sleepiness was modified by the ΔHR. Specifically, patients with higher ΔHR exhibit greater cardiovascular benefit from CPAP therapy.

Differences in Symptoms and Severity of Obstructive Sleep Apnea between Black and White Patients

Abstract: Rationale: Prior work suggests that Black patients have more severe obstructive sleep apnea (OSA) upon clinical presentation. However, the extent to which this may reflect differences in symptoms or other standard measures of OSA risk is unclear. Objectives: We assessed for racial disparities in OSA characteristics at time of initial clinical diagnosis. Methods: Data from 890 newly diagnosed patients with OSA at an urban academic sleep center were included in this analysis. All patients completed a standardized questionnaire on demographics and sleep-related symptoms and underwent laboratory polysomnography. Symptom severity at the time of evaluation was compared across race and sex. Results: Black men were underrepresented in the sleep lab, making up only 15.8% of the cohort and 31.3% of Black participants (P < 0.001). Despite this, Black men had the most severe OSA with a mean apnea hypopnea index of 52.4 ± 39.4 events/hour, compared with 39.0 ± 28.9 in White men, 33.4 ± 32.3 in Black women, and 26.2 ± 23.8 in White women (P < 0.001 for test of homogeneity). Black men also had the greatest burden of OSA symptoms with the highest mean Epworth Sleepiness Scale score (12.2 ± 5.9 versus 9.4 ± 5.2 in White men, 11.2 ± 5.9, in Black women, and 9.8 ± 5.6 in White women; P < 0.001). Compared with White men, Black men were 1.61 (95% CI [1.04–2.51]) times more likely to have witnessed apneas and 1.56 (95% CI [1.00–2.46]) times more likely to have drowsy driving at the time of OSA diagnosis. Conclusions: At the time of clinical diagnosis, Black men have greater disease severity, suggesting delay in diagnosis. Further, the greater burden of classic OSA symptoms suggests the delayed diagnosis of OSA in Black men is not due to atypical presentation. Further research is needed to identify why screening methods for OSA are not equitably implemented in the care of Black men.

Mini-implant assisted rapid palatal expansion (MARPE) effects on adult obstructive sleep apnea (OSA) and quality of life: a multi-center prospective controlled trial

Abstract: Transverse maxillary deficiency is a high prevalent growth disorder within the adult population that may lead to serious health issues, such as detrimental malocclusions and higher risk of developing obstructive sleep apnea (OSA). Mini-implant assisted rapid palatal expansion (MARPE), as it expands the mid-face and augment the nasal and oral cavities dimensions, may reduce the airflow resistance and thus play an important role on OSA therapy in some patients. The main objective of the present trial is to assess MARPE effects on the sleep and quality of life of non-obese adult OSA patients with transverse maxillary deficiency.A total of 32 participants were divided into intervention and control groups. They underwent physical evaluation, Epworth Sleepiness Scale (EES) and Quebec Sleep Questionnaire (QSQ), cone-beam computed tomography (CBCT) and home sleep testing (HST) for OSA before MARPE (T1) and 6 months after the intervention (T2).Questionnaires EES (daytime sleepiness) and QSQ (OSA-related quality of life) presented significant statistical differences between the groups. We also found clinical and statistical (p < 0.01) differences between the groups regarding the apnea/hypopnea index (AHI), as well as others HST parameters (mean oxygen saturation and snoring duration).In our sample, MARPE (without any auxiliary osteotomy) showed a good success rate (85%) and promoted important occlusal and respiratory benefits. We observed important daytime sleepiness and OSA-related quality of life improvement, as well as the AHI (65.3%), oxygen saturation and snoring duration.

Melatonin Treatment for Sleep Disorders in Parkinson's Disease: A Meta-Analysis and Systematic Review

Abstract: Objective The efficacy of melatonin on sleep disorders in Parkinson's disease (PD) is still unclear. The purpose of this study was to investigate the efficacy of melatonin on sleep disorders in PD by summarizing evidence from randomized clinical trials (RCTs). Methods PubMed, Cochrane Library, EMBASE, and Web of Science databases were searched for studies published before 20 August 2021. Results were analyzed using Review Manager 5.2 software. We used Trial Sequential Analysis (TSA) software to avoid false-positive results caused by random errors. Results We included 7 studies in this systematic review and meta-analysis. The results of the meta-analysis showed that compared with placebo, the subjective sleep quality of patients with PD significantly improved after melatonin treatment (MD = −2.19, 95% CI: −3.53 to −0.86, P = 0.001). In the systematic review, we qualitatively analyzed the efficacy of melatonin on the objective sleep quality of patients with PD, and the results showed that melatonin exerted a positive effect with good safety and tolerability. However, there was no significant improvement in excessive daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS). Conclusion We found that melatonin can significantly improve the subjective and objective sleep quality of patients with PD with good safety and tolerability. Melatonin could be considered an effective treatment for insomnia in patients with PD.

Sleeping through a pandemic: impact of COVID-19–related restrictions on narcolepsy and idiopathic hypersomnia

Abstract: To assess the impact of coronavirus disease 2019 (COVID-19)-related restrictions on narcolepsy type 1 (NT2), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).Participants with NT1, NT2, and IH followed in a university hospital completed an online 78-question survey assessing demographic, clinical, and occupational features of the population during the first COVID-19-related lockdown.A total of 219 of 851 (25.7%) respondents of the survey reported a mean increase of 1.2 ± 1.9 hours (P < .001) in night sleep time and a mean decrease of 1.0 ± 3.4 points (P < .001) on the Epworth Sleepiness Scale during lockdown. Bedtime was delayed by 46.1% of participants and wakeup time was delayed by 59.6%, driven primarily by participants with IH. Teleworkers (but not in-person workers) reported a mean increase of 0.9 ± 1.2 hours in night sleep (P < .001) and a mean decrease in sleepiness score of 1.6 ± 3.1 (P < .001). Cataplexy improved in 54.1% of participants with NT1. Sleepiness correlated with psychological wellness (r = .3, P < .001). As many as 42.5% enjoyed the lockdown, thanks to reallocation of time usually spent commuting toward longer sleep time, hobbies, and family time, and appreciated a freer napping schedule. Conversely, 13.2% disliked the lockdown, feeling isolation and psychological distress.Extended sleep time, circadian delay (in patients with IH), and teleworking resulted in decreased symptoms of central hypersomnias. These findings suggest that people with IH, NT1, and NT2 may benefit from a decrease in social and professional constraints on sleep-wake habits, and support advocacy efforts aimed at facilitating workplace and schedule accommodations for this population.Nigam M, Hippolyte A, Dodet P, et al. Sleeping through a pandemic: impact of COVID-19-related restrictions on narcolepsy and idiopathic hypersomnia. J Clin Sleep Med. 2022;18(1):255-263.

Prevalence of common sleep disorders in a middle-aged community sample.

Abstract: STUDY OBJECTIVES There are a paucity of contemporary prevalence estimates for common sleep disorders of insomnia, obstructive sleep apnea (OSA) and restless legs syndrome (RLS). We aimed to assess the prevalence of clinically significant common sleep disorders in a middle-aged community sample. METHODS Parents of participants in the community-based Raine Study , underwent assessments between 2015-2017, including comprehensive questionnaires, anthropometric measures and in-laboratory polysomnography. Clinically significant sleep disorders were defined as: chronic insomnia using the Pittsburgh Sleep Symptom Questionnaire-Insomnia with duration criterion ≥3 months; OSA as apnea-hypopnea index (AHI) ≥ 5 events/h with excessive sleepiness (Epworth Sleepiness Scale ≥ 11) or AHI ≥ 15 events/h (even in the absence of symptoms); RLS when participants endorsed the International Restless Legs Syndrome Study Group diagnostic criteria (2003) with symptoms ≥ 5 times/mo involving moderate-severe distress. RESULTS At least one sleep-related assessment was completed by 1,005 (female = 586, 58.3%) middle-aged (45-65 years) participants; 72.5% of eligible Raine Study parents. The respective prevalences for clinically significant disease in females and males were: OSA, 24.0% (95% CI: 20.5-27.7) and 47.3% (95% CI: 42.2-53.4); insomnia, 15.8% (95% CI: 13.1-19.0) and 9.3% (95% CI: 6.8-12.4); RLS, 3.7% (95% CI: 2.4-5.4) and 2.2% (95% CI: 1.1-3.9). At least one sleep disorder was present in 42.9% of those with complete data on all assessments (n = 895). CONCLUSIONS Common sleep disorders are highly prevalent, to a clinically important extent, in an Australian community sample of middle-aged adults. Contemporary OSA prevalence is notably higher than previously reported and further work is needed to determine the communal impact of OSA.

Predictors and outcomes of obstructive sleep apnea in patients with chronic obstructive pulmonary disease in China

Abstract: "Overlap syndrome" refers to obstructive sleep apnea (OSA) combined with chronic obstructive pulmonary disease (COPD), and has poorer outcomes than either condition alone. We aimed to evaluate the prevalence and possible predictors of overlap syndrome and its association with clinical outcomes in patients with COPD.We assessed the modified Medical Research Council dyspnea scale (mMRC), Epworth sleepiness scale (ESS), COPD assessment test (CAT), Hospital Anxiety and Depression Scale (HADS), Charlson Comorbidity Index (CCI), and STOP-Bang questionnaire (SBQ) and performed spirometry and full overnight polysomnography in all patients. An apnea-hypopnea index (AHI) ≥ 5 events per hour was considered to indicate OSA. Risk factors for OSA in COPD patients were identified by univariate and multivariate logistic regression analyses.A total of 556 patients (66%) had an AHI ≥ 5 events per hour. There were no significant differences in age, sex ratio, mMRC score, smoking index, number of acute exacerbations and hospitalizations in the last year, and prevalence of cor pulmonale between the two groups (all p > 0.05). Body mass index (BMI), neck circumference, CAT score, CCI, ESS, HADS, and SBQ scores, forced expiratory volume (FEV)1, FEV1% pred, FEV1/forced vital capacity ratio, and prevalence of hypertension, coronary heart disease, and diabetes were all significantly higher and the prevalence of severe COPD was significantly lower in the COPD-OSA group compared with the COPD group (p < 0.05). BMI, neck circumference, ESS, CAT, CCI, HADS, hypertension, and diabetes were independent risk factors for OSA in COPD patients (p < 0.05). SBQ could be used for OSA screening in patients with COPD. Patients with severe COPD had a lower risk of OSA compared with patients with mild or moderate COPD (β = - 0.459, odds ratio = 0.632, 95% confidence interval 0.401-0.997, p = 0.048).Patients with overlap syndrome had a poorer quality of life, more daytime sleepiness, and a higher prevalence of hypertension and diabetes than patients with COPD alone. BMI, neck circumference, ESS, CAT, CCI, HADS, hypertension, and diabetes were independent risk factors for OSA in patients with COPD. The risk of OSA was lower in patients with severe, compared with mild or moderate COPD.

Impaired Glymphatic System Actions in Obstructive Sleep Apnea Adults

Abstract: Study Objectives Obstructive sleep apnea (OSA) is accompanied by sleep fragmentation and altered sleep architecture, which can potentially hinder the glymphatic system, increasing risks for Alzheimer’s disease (AD), but the status is unclear in OSA. Our aim was to investigate the glymphatic system in OSA subjects and examine the relationships between OSA disease severity, sleep symptoms, and glymphatic system indices in OSA using diffusion tensor imaging (DTI). Methods We acquired DTI data from 59 OSA and 62 controls using a 3.0-Tesla MRI and examined OSA disease severity and sleep symptoms with the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS). Diffusivity maps in the x-axis (Dxx), y-axis (Dyy), and z-axis (Dzz), as well as in x-y axis (Dxy), y-z axis (Dyz), and x-z axis (Dxz) were calculated, diffusion values for the projection and association fibers extracted, and the DTI analyses along the perivascular space (DTI-ALPS index) were performed. The glymphatic system indices were compared between groups and correlated with disease severity and sleep symptoms in OSA subjects. Results Dzz values, derived from projection fiber areas, Dyy and Dzz values from association fiber areas, as well as ALPS and Dyzmean values were significantly reduced in OSA over controls. Significant correlations emerged between disease severity, sleep symptoms, and Dxy, Dxx, and Dzz values in OSA subjects. Conclusion OSA patients show abnormal glymphatic system function that may contribute to increased risks for AD. The findings suggest that the APLS method can be used to assess the glymphatic system in OSA patients.

Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers’ Fear of Hypoglycemia and Improves Their Well-being

Abstract: OBJECTIVE To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers’ well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS We conducted a multinational, open-label, randomized crossover study. Children (age 1–7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization–Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.

Obstructive sleep apnoea and adherence to continuous positive airway therapy among Australian women

Abstract: Clinical characteristics of women with different obstructive sleep apnoea (OSA) severity and adherence to continuous positive airway pressure (CPAP) therapy have not been previously explored.To assess OSA prevalence, predictors, clinical and polysomnographic (PSG) characteristics and adherence to CPAP therapy among adult Australian women in a retrospective study.All female patients who underwent a diagnostic PSG between 2014 and 2015 were included. CPAP adherence was assessed during the study period between 2018 and 2019 using multiple regression models.Among a total of 591 women included in this study (Aboriginal, n = 86), OSA was diagnosed in 458/591 (78%) patients; mild, moderate and severe OSA was present in 44%, 27% and 29% respectively. Older age, higher BMI and hypertension predicted the presence and severity of OSA. The Epworth Sleepiness Scale (ESS) score was not significantly different with (8 (5, 12)) or without (10 (5, 13)) OSA. PSG showed the rapid eye movement (REM) sleep-associated apnoea-hypopnea index (AHI) was higher with all severity of OSA. Adherence to CPAP therapy was noted in 171 (57%) patients; 47% mild, 57% moderate and 63% with severe OSA respectively. Three multiple regression models (clinical, PSG parameters, OSA severity, combined (clinical and PSG)) showed the combined model had the strongest predictive value and demonstrated that higher ESS and more severe oxygen desaturation were associated with CPAP adherence irrespective of OSA severity.Older age, higher BMI and the presence of hypertension predicted the presence of OSA. The REM sleep-related AHI was higher. Adherence to CPAP was associated with symptomatic OSA and severe oxygen desaturation.

Association of Hypoglossal Nerve Stimulation With Improvements in Long-term, Patient-Reported Outcomes and Comparison With Positive Airway Pressure for Patients With Obstructive Sleep Apnea

Abstract:

Importance

Hypoglossal nerve stimulation (HNS) and positive airway pressure (PAP) have been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA). However, to our knowledge, there are no data that compare change in PROs between HNS and PAP or that indicate whether HNS improves comorbid insomnia or depression in the long term.

Objectives

To determine whether HNS is associated with improvements in patient-reported sleepiness, insomnia, and depression in the long term and to compare the respective associations of HNS and PAP with improved PROs.

Design, Setting, and Participants

This retrospective cohort study used data from patients treated at the Cleveland Clinic for OSA. Participants received either HNS (referred sample) from November 1, 2015, to September 31, 2018, or PAP (previous cohort) from January 1, 2010, to December 31, 2014, for OSA. Patients were matched 3:1 for PAP:HNS based on age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), sex, and apnea hypopnea index (AHI). Data were collected at baseline and at prespecified follow-up points. Data were analyzed from March 26, 2020, to September 9, 2021.

Exposures

Treatment with HNS vs PAP.

Main Outcomes and Measures

Data collected included AHI and Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Patient Health Questionnaire-9 (PHQ-9; depression) scores.

Results

Among 85 patients receiving HNS (mean [SD] age, 62.8 [9.5] years; 59 men [69.4%]; 77 White patients [90.6%]; mean [SD] BMI, 28.8 [3.1]), compared with 217 matched patients receiving PAP (mean [SD] age, 62.1 [9.9] years; 157 men [72.4%]; 173 White patients [81.2%]; mean [SD] BMI, 29.5 [3.1]) included in the analysis, significant improvements were seen in PHQ-9 scores for HNS vs PAP (least square means, −4.06 [95% CI, −5.34 to −2.79] vs −2.58 [95% CI, −3.35 to −1.82]; mean difference, −1.48 [95% CI, −2.78 to −0.19]) with comparable improvements in ESS, FOSQ, and ISI scores. Clinically meaningful differences were observed in 42 of 65 HNS group patients (64.6%) vs 118 PAP group patients (54.5%) for ESS scores, 29 of 49 HNS group patients (59.2%) vs 67 of 217 PAP group patients (30.9%) for FOSQ scores, 14 of 48 HNS group patients (29.2%) vs 53 of 217 PAP group patients (24.4%) for PHQ-9 scores, and 23 of 49 HNS group patients (46.9%) vs 79 of 217 PAP group patients (36.4%) for ISI scores. At the 1-year post-HNS assessment, meaningful improvements were seen in 17 of 28 patients (60.7%) for ESS scores, 11 of 20 patients (55.0%) for FOSQ scores, 7 of 23 patients (30.4%) for PHQ-9 scores, and 11 of 25 patients (44.0%) for ISI scores.

Conclusions and Relevance

In this cohort study of patients with OSA, sustained improvements in PROs were observed 1 year after HNS and were comparable to those for PAP at 3 months. These findings suggest that HNS is a viable treatment for improving insomnia and depression in patients with OSA.

The Efficiency of Orofacial Myofunctional Therapy in Treating Obstructive Sleep Apnea: A Meta-Analysis of Observational Studies.

Abstract: OBJECTIVE The literature on orofacial myofunctional therapy (OMT) in children and adults with obstructive sleep apnea (OSA) was systematically reviewed to investigate the effects of OMT on patients with OSA by age and disease severity to verify the effect of OMT on OSA. DATA SOURCES All the comparative literature was retrieved from the PubMed, Embase, and Cochrane libraries. METHOD We searched the articles published up to February 12, 2022 and followed the preferred reporting project for systematic review and meta-analysis of reports. The quality of the studies was evaluated using the Newcastle-Ottawa scale. RESULTS Of the primary indicators for evaluating OSA, 13 studies reported on the apnea index (AHI), showing a decrease in the mean standard deviation of AHI from before OMT to after OMT (P < 0.00001). The lowest oxygen saturation was reported in nine studies, and the mean standard deviation of the lowest oxygen saturation increased from before to after OMT (P = 0.0009). Ten studies reported the Epworth Sleepiness Scale (ESS), indicating that the mean standard deviation of the ESS decreased from before to after OMT (P < 0.00001). The subgroup analysis showed that the AHI scores indicating mild and moderate OSA were significantly reduced, and the AHI scores indicating severe OSA also decreased, but this was not statistically significant. The lowest oxygen saturation increased obviously in patients with both mild and moderate and severe OSA. Of the secondary indicators of OSA, there was a statistically significant improvement in snoring intensity (P = 0.0002). CONCLUSION Oral and facial muscular function therapy can be used as a simple and non-invasive new technique to improve the AHI, minimum oxygen saturation, ESS, and snoring intensity in patients with mild and moderate OSA and the lowest oxygen saturation in patients with severe OSA.

A meta-analysis to identify factors associated with CPAP machine purchasing in patients with obstructive sleep apnea

Abstract: Obstructive sleep apnea (OSA) is a common disease and related to several cardiovascular diseases. Treatment with a continuous positive airway pressure (CPAP) machine is effective. However, not all patients with OSA purchase a CPAP machine for personal use. Previous studies showed different predictors of CPAP machine purchasing in patients with OSA. The present study aimed to summarize and identify predictors of CPAP purchasing using meta-analysis. The study was conducted using factors associated with CPAP purchasing in patients with OSA. The types of studies conducted in adult patients with OSA included: Randomized controlled trials, observational studies or descriptive studies comparing factors between those who purchased CPAP and those who did not. A total of five databases, including PubMed, Central database, Scopus, CINAHL Plus and Web of Science, were searched, and the final search was performed on February 8, 2021. Predictors for CPAP purchasing were determined. There were 598 articles from five databases, which met the inclusion criteria. After duplicated article removal, 390 articles were included in the screening process. There were 12 eligible articles for full text evaluation, and of those, eight studies met the study criteria with 1,605 patients from four countries. There were 11 variables that were available for a comparison between those who purchased the CPAP machine and those who did not, and six factors were different between the two groups: Age, years of education, income, smoking, Epworth Sleepiness Scale (ESS) score and apnea hypopnea index/respiratory disturbance index (AHI/RDI). The AHI/RDI was significantly different between the two groups, with the highest mean difference of 10.40 events/h (95% CI, 4.95-15.86). Patients who purchased CPAP were older (1.11 years), had more years of education (0.93 years), smoked more (1.15 pack/year), and had both higher ESS (0.61) and AHI/RDI (10.40) than those who did not purchase CPAP. Additionally, those who purchased CPAP had a 1.47 times higher income than those who did not. In conclusion, specific personal customer and clinical factors were related to the decision of CPAP purchase in patients with OSA.

Assessment of Insomnia Symptoms, Quality of Life, Daytime Sleepiness, and Psychoactive Substance Use among Polish Students: A Cross-Sectional Online Survey for Years 2016–2021 before and during COVID-19 Pandemic

Abstract: Sleep disorders are a serious health problem worldwide, and insomnia is their most common manifestation. An increasing number of people have insomnia every year, young adults, especially. Due to the importance that sleep has in almost every aspect of our lives, the need to monitor disturbances in circadian rhythms has arisen. Therefore, this study aimed to assess the prevalence of sleep disorders among Polish students, including their quality of life (QOL) and drug use patterns. The study also investigated associations between sleep, QoL, and drug use. The study was conducted in 2016–2021 based on the self-made sociodemographic questionnaire, as well as standardized psychometric tools: Athens Insomnia Scale (AIS), Epworth Sleepiness Scale (ESS), and Manchester Short Assessment of quality of life (MANSA). A total of 14,844 students participated in the study. The majority were women (80.7%), of which 3425 (23.1%) were medical students, with the most numerous representing medical and dental faculties, 1884 (57.2%). Before the COVID-19 pandemic, 52.1% of the surveys were collected; 54.1% of respondents had insomnia as indicated by the AIS scores, and 26.1% displayed sleepiness during the day. Female students, the first-year college students, more often suffered from sleep disorders. Drug use was widespread among Polish students, correlating with sleep assessment results and QoL. In conclusion, sleep disorders are a significant clinical problem among Polish students. Female and junior students’ years are more prone to sleep deprivation. Insufficient sleep can be associated with a lower QoL score and psychoactive substance use. The effects of the COVID-19 pandemic on sleep are not conclusive, because there was decreasing quality for longer sleep durations. In order to analyze these associations, there is a need for further in-depth study.

Sleep disturbance in alopecia areata: A cross‐sectional study

Abstract: Alopecia areata (AA) is a nonscarring hair loss with autoimmune pathophysiology, which is associated with psychiatric disorders including anxiety and depression. Sleep disorders are commonly seen with anxiety and depression. Here we evaluate the sleep quality of AA patients.

Screening for Obstructive Sleep Apnea in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Abstract: Importance Obstructive sleep apnea (OSA) is associated with adverse health outcomes. Objective To review the evidence on screening for OSA in asymptomatic adults or those with unrecognized OSA symptoms to inform the US Preventive Services Task Force. Data Sources PubMed/MEDLINE, Cochrane Library, Embase, and trial registries through August 23, 2021; surveillance through September 23, 2022. Study Selection English-language studies of screening test accuracy, randomized clinical trials (RCTs) of screening or treatment of OSA reporting health outcomes or harms, and systematic reviews of treatment reporting changes in blood pressure and apnea-hypopnea index (AHI) scores. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality. Meta-analysis of intervention trials. Main Outcomes and Measures Test accuracy, excessive daytime sleepiness, sleep-related and general health-related quality of life (QOL), and harms. Results Eighty-six studies were included (N = 11 051). No study directly compared screening with no screening. Screening accuracy of the Multivariable Apnea Prediction score followed by unattended home sleep testing for detecting severe OSA syndrome (AHI ≥30 and Epworth Sleepiness Scale [ESS] score >10) measured as the area under the curve in 2 studies (n = 702) was 0.80 (95% CI, 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90). Five studies assessing the accuracy of other screening tools were heterogeneous and results were inconsistent. Compared with inactive control, positive airway pressure was associated with a significant improvement in ESS score from baseline (pooled mean difference, -2.33 [95% CI, -2.75 to -1.90]; 47 trials; n = 7024), sleep-related QOL (standardized mean difference, 0.30 [95% CI, 0.19 to 0.42]; 17 trials; n = 3083), and general health-related QOL measured by the 36-Item Short Form Health Survey (SF-36) mental health component summary score change (pooled mean difference, 2.20 [95% CI, 0.95 to 3.44]; 15 trials; n = 2345) and SF-36 physical health component summary score change (pooled mean difference, 1.53 [95% CI, 0.29 to 2.77]; 13 trials; n = 2031). Use of mandibular advancement devices was also associated with a significantly larger ESS score change compared with controls (pooled mean difference, -1.67 [95% CI, 2.09 to -1.25]; 10 trials; n = 1540). Reporting of other health outcomes was sparse; no included trial found significant benefit associated with treatment on mortality, cardiovascular events, or motor vehicle crashes. In 3 systematic reviews, positive airway pressure was significantly associated with reduced blood pressure; however, the difference was relatively small (2-3 mm Hg). Conclusions and Relevance The accuracy and clinical utility of OSA screening tools that could be used in primary care settings were uncertain. Positive airway pressure and mandibular advancement devices reduced ESS score. Trials of positive airway pressure found modest improvement in sleep-related and general health-related QOL but have not established whether treatment reduces mortality or improves most other health outcomes.

Impact of Obstructive Sleep Apnea (OSA) in COVID-19 Survivors, Symptoms Changes Between 4-Months and 1 Year After the COVID-19 Infection

Abstract: Objective To determine the association between Obstructive Sleep Apnea (OSA) with long-term symptoms and inflammatory cytokines, exploring the changes between 4-months and 1-year after COVID-19 infection. Methods We conducted an observational, prospective cohort study, including patients ≥18 years old with confirmed diagnosis of COVID-19 between April to July 2020. All participants underwent two clinical follow-up visits, the first at 4-months (Visit 1) and the second at 1 year, after SARS-CoV-2 infection (Visit 2). Plasma glucose, total cholesterol, HDL, and triglycerides. Regarding pulmonary function, spirometry and lung diffusion capacity tests were assessed. For mental and neurocognitive evaluation, a short-form (SF-12), Beck depression and Hospital-Anxiety depression questionnaires were conducted at both time-points, whereas the Montreal Cognitive assessment was conducted during the second follow-up. Regarding to sleep evaluation, Epworth Sleepiness Scale, Insomnia Severity index and STOP-BANG questionnaire were conducted. Additionally, a home sleep apnea test and 7-day wrist actigraphy were performed in all participants. Inflammatory cytokines were measured using an inflammatory cytokine bead array kit. p-values < 0.05 were considered statistically significant and statistical analyses were performed using R software. Results A total of 60 patients were included in the first follow-up, from which 57 completed the second follow-up. The mean age was 46.4 years-old (SD ± 13.1) and 53.3% were male. 30% of cases reported mild COVID-19 infection, 28.3% with moderate illness, and 41.6% with severe illness. Moreover, 56.6% of them were admitted to the ICU. Regarding to metabolic values, the OSA group showed higher values of insulin resistance (IR) (27%), systolic blood pressure (SBP) 135.2 (±19.1), dyslipidemia (67.5%), total cholesterol 202.1 (±60.5), triglycerides 176.1 (±119.0) and HOMA-IR 9.0 (±18.8) in comparison with the non-OSA group. 1 year after COVID-19 infection, DLCO test remains abnormal in OSA patients (25% OSA vs. 3.6% non-OSA, p = 0.02). Finally, those participants with OSA who develop ARDS reported an adjusted OR 20.4 (95%-CI, 1.04–504) risk of neurocognitive impairment. Discussion Among patients with previous COVID-19, OSA impact the development of incident glycemic, neurocognitive impairment, and abnormal functional pulmonary changes that persist up to 1 year since acute phase.

Self-reported sleep characteristics associated with dementia among rural-dwelling Chinese older adults: a population-based study

Abstract: Sleep characteristics associated with dementia are poorly defined and whether their associations vary by demographics and APOE genotype among older adults are unclear.This population-based cross-sectional study included 4742 participants (age ≥ 65 years, 57.1% women) living in rural China. Sleep parameters were measured using the self-rated questionnaires of the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale. Global cognitive function was assessed with the Mini-Mental State Examination (MMSE). Dementia was diagnosed following the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria, and the National Institute on Aging-Alzheimer's Association criteria for Alzheimer's disease (AD). Data were analysed using multiple logistic and general linear regression models.Dementia was diagnosed in 173 participants (115 with AD). Multivariable-adjusted odds ratio (OR) of dementia was 1.71 (95%CI, 1.07-2.72) for sleep duration ≤4 h/night (vs. > 6-8 h/night), 0.76 (0.49-1.18) for > 4-6 h/night, 1.63 (1.05-2.55) for > 8 h/night, 1.11 (1.03-1.20) for lower sleep efficiency (per 10% decrease), and 1.85 (1.19-2.89) for excessive daytime sleepiness. Very short sleep duration (≤4 h/night), lower sleep efficiency, and excessive daytime sleepiness were significantly associated with being diagnosed with AD (multivariable-adjusted OR range = 1.12-2.07; p < 0.05). The associations of sleep problems with dementia and AD were evident mainly among young-old adults (65-74 years) or APOE ε4 carriers. Among dementia-free participants, these sleep characteristics were significantly associated with a lower MMSE score.Self-reported sleep problems in dementia are characterized by very short or long sleep duration, low sleep efficiency, and excessive daytime sleepiness, especially among young-old people and APOE ε4 carriers.ChiCTR1800017758 (Aug 13, 2018).

Investigation and management of residual sleepiness in CPAP-treated patients with obstructive sleep apnoea: the European view

Abstract: Excessive daytime sleepiness (EDS) is a major symptom of obstructive sleep apnoea (OSA), defined as the inability to stay awake during the day. Its clinical descriptors remain elusive, and the pathogenesis is complex, with disorders such as insufficient sleep and depression commonly associated. Subjective EDS can be evaluated using the Epworth Sleepiness Scale, in which the patient reports the probability of dozing in certain situations; however, its reliability has been challenged. Objective tests such as the multiple sleep latency test or the maintenance of wakefulness test are not commonly used in patients with OSA, since they require nocturnal polysomnography, daytime testing and are expensive. Drugs for EDS are available in the United States but were discontinued in Europe some time ago. For European respiratory physicians, treatment of EDS with medication is new and they may lack experience in pharmacological treatment of EDS, while novel wake-promoting drugs have been recently developed and approved for clinical use in OSA patients in the USA and Europe. This review will discuss 1) the potential prognostic significance of EDS in OSA patients at diagnosis, 2) the prevalence and predictors of residual EDS in treated OSA patients, and 3) the evolution of therapy for EDS specifically for Europe. Drugs for EDS are available in the USA but were discontinued in Europe some time ago. For European sleep doctors, treatment of EDS with medication is new, while novel wake-promoting drugs have been developed and approved for clinical use in OSA patients. https://bit.ly/3u9y3Ln

Relationships between quality of life, sleep problems, and sleep quality in patients with chronic idiopathic urticaria

Abstract: In this study, we aimed to evaluate the sleep quality among chronic urticaria patients using the Chronic Urticaria Quality‐of‐Life Questionnaire (CU–Q2oL), sleep quality assessment tools, and polysomnography and to investigate any relationships between the obtained results.

Correlates of excessive daytime sleepiness in obstructive sleep apnea: Results from the nationwide SESAR cohort including 34,684 patients

Abstract: Excessive daytime sleepiness (EDS) is a hallmark symptom in obstructive sleep apnea (OSA). It is commonly eliminated by obstructive sleep apnea therapy and constitutes a major treatment indication. This study aimed to identify determinants of excessive daytime sleepiness by the Epworth Sleepiness Scale (ESS) scores in the large, representative national obstructive sleep apnea patient cohort of the Swedish Sleep Apnea Registry (SESAR, www.sesar.se). Data from 34,684 patients with obstructive sleep apnea recruited at 23 sites (33% females, mean age 55.7 ± 13.7 years, BMI 30.2 ± 6.3 kg/m2, AHI 29.1 ± 22.3, and ODI 24.9 ± 21.4 events/h) had a mean ESS score in the mild to moderate excessive daytime sleepiness range (9.7 ± 4.9). The proportion of patients with excessive daytime sleepiness was 41.4% in men and 44.6% in women. Independent predictors of excessive daytime sleepiness included gender, age, and hypoxic markers (high ODI and low mean saturation). Univariate and multivariate analyses were used to identify significant predictors for the ESS score and for excessive daytime sleepiness (ESS ≥10) amongst anthropometric factors, sleep apnea frequency (apnea‐hypopnea index (AHI)), markers of intermittent hypoxia (oxygen desaturation index (ODI), mean saturation (mSaO2)), as well as prevalent comorbidities. Depression was associated with higher ESS scores and hypertension/atrial fibrillation with lower scores. The oxygen desaturation index provided a stronger predictor of excessive daytime sleepiness than the apnea‐hypopnea index. The severity of obstructive sleep apnea, captured as the apnea‐hypopnea index, was only weakly associated with daytime sleepiness in this representative obstructive sleep apnea patient cohort. Age had different effects in men and women.The impact of obstructive sleep apnea in a wider patient related perspective needs to be determined after the inclusion of factors other than the apnea‐hypopnea index.