Daytime Sleepiness In Patients Research Articles

Ketogenic diet may improve sleep quality and daytime somnolence in patients affected by multiple sclerosis. Results of an exploratory study

Objective/backgroundPatients with multiple sclerosis (MS) frequently report sleep complaints. The ketogenic diet (KD) is safe and tolerable in MS patients. Our aim was: 1) to investigate the effects of KD on sleep complaints in patients affected by relapsing-remitting MS and 2) to verify if sleep changes can positively impact on psychological status and quality of life (QoL) in these patients. Patients/methodsFrom January 2020 to November 2022, we consecutively enrolled 21 non-disabled or minimally disabled MS patients. We collected information regarding: 1) anthropometric measures; 2) psychological status by the Depression Anxiety Stress Scale-21; 3) QoL by the Multiple Sclerosis Quality of Life-54 (MSQOL-54); 4) subjective sleep complaints, i.e. sleep quality, by the Pittsburgh Sleep Quality Index (PSQI), and excessive daytime sleepiness (EDS), by the Epworth Sleepiness Scale (ESS). ResultsAfter 6 months of KD therapy, anthropometric measures considerably changed, psychological status significantly improved, and almost all the MSQOL-54 subscales ameliorated. Regarding sleep, we observed that the global PSQI (T0: 7.7 ± 3.1 versus T1: 4.4 ± 3.1, p = 0.002) and the ESS (T0: 7.5 ± 3.9 versus T1: 4.9 ± 3.2, p = 0.001) scores significantly decreased after KD therapy. At T1, only the global PSQI score was an independent predictor of anxiety, stress, and mental health. ConclusionsFor the first time, we demonstrated that KD may improve sleep complaints in MS patients. In addition, KD seems to have a positive impact on psychological status and QoL of MS patients, mainly through improving sleep quality. Further controlled studies with larger sample sizes are needed to confirm these preliminary results.

Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients with Narcolepsy: A Commentary.

Narcolepsy is associated with disrupted nighttime sleep (DNS). Sodium oxybate (SXB; Xyrem®), administered twice nightly, is indicated for the treatment of cataplexy and excessive daytime sleepiness in patients 7years or older with narcolepsy. Recently, low-sodium oxybate (LXB, Xywav®; for people 7years of age and older), which contains 92% less sodium than SXB and is dosed twice nightly, and sodium oxybate for extended release (SXB-ER; Lumryz™; for adults), which contains equal sodium to SXB and is dosed once nightly, have also been approved to treat cataplexy or excessive daytime sleepiness in narcolepsy. This paper reviews the evidence regarding the overall impact of oxybate administration, and impact of different oxybate dosing regimens (once nightly, SXB-ER; twice nightly, SXB), on DNS in narcolepsy utilizing polysomnographic data from five clinical trials (three assessing SXB in adults [referred to here as SXB trials1, 2, and 3], one assessing SXB in children [referred to as the pediatric SXB trial], and one assessing SXB-ER in adults [REST-ON]). Both once-nightly and twice-nightly oxybate regimens similarly improved symptoms of DNS. Regardless of dosing regimen, people with narcolepsy treated with oxybate experience roughly 42-53 arousals and 9-38 awakenings each night, with one of these awakenings on twice-nightly oxybate being due to the second dosing requirement in studies of SXB. Additionally, for SXB, but not SXB-ER, polysomnographic data has been analyzed by half of the night, demonstrating a greater positive impact on sleep architecture in the second half of the night, which might be related to its nonlinear pharmacokinetic profile. We conclude that while once-nightly and twice-nightly oxybate dosing regimens differ in their pharmacokinetic profiles, both improve DNS in patients with narcolepsy to a similar degree.

Positive Pressure Ventilation Treatment Based on Daytime and Night-time Titration in Patients with Obesity Hypoventilation Syndrome: A Randomized Controlled Trial.

Objectives The aim of the present study was to investigate the improvements of gas exchange and excessive daytime sleepiness in patients with obesity hypoventilation syndrome (OHS) in daytime and night-time split polysomnography (DSPSG and NSPSG). Materials and Methods In the present randomized controlled trial, patients with OHS were enrolled in two DSPSG (51 patients) and NSPSG (50 patients) groups in the Bamdad respiratory and sleep research center in Isfahan, Iran. In both groups, the diagnostic polysomnography (PSG) and titration were conducted in one session according to the guidelines of NSPSG. SpO2, PaCO2, and the Epworth Sleepiness Scale (ESS), were measured initially and 12 weeks after treatment. Furthermore, the PSG parameters and the type of treatments for the two groups were recorded and analyzed. Results A total of 101 OHS patients (age: 62.02 ± 12.4 year old; 61 females [60.4%]) were evaluated. There were no significant differences regarding BMI, gender, and AHI between groups ( p > 0.05). Primary SpO2, PaCO2, and ESS were not significantly different between the two groups. After 12 weeks of treatment by continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), there were significant improvement of SpO2, PaCO2, and ESS score ( p < 0.001). The amount of change of these variables was not different between groups. Among all variables, only the lower SpO2 and higher PaCO2 were associated with response to BiPAP. Discussion There were no significant differences in the number of changes of SpO2, PaCO2, and ESS by treatment in the DSPSG and NSPSG groups. Therefore, DSPSG may be considered as a valuable alternative method for the diagnosis and titration in OHS patients. Clinical Trials IRCT20170512033930N2.

Factors correlated with excessive daytime sleepiness in patients with Parkinson's disease: A polysomnography study.

To explore the factors correlated with excessive daytime sleepiness (EDS) in patients with Parkinson's disease (PD). A total of 239 PD patients were divided into two groups based on the presence of EDS (Epworth Sleepiness Scale score≥10) (PD-EDS vs. PD-non-EDS). Participants underwent an extensive assessment to determine demographic features, disease severity, polysomnography characteristics, and nonmotor symptoms. Of the 239 patients, 56 patients (23.4%) were classified as having PD combined with EDS. Binary logistic regression analysis showed that fatigue (Fatigue Severity Scale [FSS] score ≥4) (odds ratio [OR] [95% CI]=4.897 [2.376-10.095], p<.001) and the respiratory-related microarousal index (OR [95% CI]=2.063 [1.085-3.923], p=.027) were independent risk factors for EDS in PD patients. A priori-determined stratified analysis showed that after adjustment for confounding factors, the association of the respiratory-related microarousal index with EDS was significant (OR=4.404, 95% CI 1.673-11.592, p trend=.036) in patients with respiratory arousal index scores in the highest quintile compared with those with scores in the lowest quintile. Our data revealed a close association among the respiratory-related microarousal index, FSS scores, and EDS. It can be speculated that fragmented sleep and pathological abnormalities of the central nervous system resulting in changes in arousal are major influencing factors of EDS in PD.

Sleep Architecture and Daytime Sleepiness in Patients with Erectile Dysfunction.

Obstructive sleep apnea is considered a risk factor for erectile dysfunction. The aim of this study was to determine sleep architecture and assess daytime sleepiness in patients with erectile dysfunction. The study group included 280 patients. The 107 enrolled patients had reported erectile dysfunction. The control group consisted of 173 patients who had no history of erectile dysfunction. The Epworth sleepiness scale (ESS) was used to measure the subjects' level of daytime sleepiness. All patients underwent a standardized overnight, single-night polysomnography in sleep laboratory. In the erectile dysfunction group, we observed increased ESS total score and N1 sleep phase duration. Mean and minimal oxygen saturation and mean oxygen desaturation were decreased in comparison to the control group. In summary, subjects with erectile dysfunction have altered sleep architecture, oxygen saturation parameters and increased daytime sleepiness.

Effect of second-generation antihistamines on nighttime sleep and daytime sleepiness in patients with allergic rhinitis.

The daytime tiredness experienced by the vast majority of allergic rhinitis (AR) sufferers is directly related to the fact that they experience disrupted sleep at night. This study compared the effects of recently marketed second-generation H1 antihistamines (SGAs) on nighttime sleep and daytime sleepiness in patients with AR, with patients grouped into those taking non-brain-penetrating antihistamines (NBP group) and those taking brain-penetrating antihistamines (BP group). Patients with AR completed self-administered questionnaire-based surveys to determine Pittsburgh Sleep Quality Index (PSQI) before and after taking SGAs. Statistical analysis was performed on each evaluation item. Of 53 Japanese patients with AR between 6 and 78years old, median (SD) agewas 37.0 (22.4) years old and 21 weremen (40%). Of the 53 patients, 34 were the NBP group and 19 were the BP group. In the NBP group, mean (SD) subjective sleep quality score after medication was 0.76 (0.50), which was significantly lower (better) than the score of 0.97 (0.52) before medication (p = 0.020). In the BP group, mean (SD) subjective sleep quality score after medication was 0.79 (0.54), which was not significantly different from the score of 0.74 (0.56) before medication (p = 0.564). In the NBP group, mean (SD) global PSQI score was 3.47 (1.71) after medication, which was significantly lower (better) than the score of 4.35 (1.92) before medication (p = 0.011). In the BP group, mean (SD) global PSQI score was 2.47 (2.39) after medication, which was not significantly different from the score of 3.00 (2.71) before medication (p = 0.125). Subjective sleep quality and global PSQI score were improved only in the group taking non-brain-penetrating SGAs.

Effect of Subthalamic Nucleus Deep Brain Stimulation Treatment on Non-motor Symptoms and Sleep Quality in Parkinson’s Disease Patients

Aim: To evaluate the effect of subthalamic nucleus deep brain stimulation (STN-DBS) on non-motor symptoms (NMS), sleep quality, and excessive daytime sleepiness in patients with Parkinson’s Disease (PD). Method: Sixteen PD patients, who had undergone bilateral STN-DBS surgery were enrolled. The patients were assessed at the baseline and 12 months after surgery using the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Beck Depression Inventory-II (BDI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Non-Motor Symptom Questionnaire (NMS-Quest). Results: The mean age of the patients at the time of surgery was 53.5±3.6 years. There were significant improvements in the levodopa-equivalent daily dose, UPDRS-part-II, UPDRS-part-III, and UPDRS-part-IV at 12 months post-DBS surgery. The NMS-Quest total score at baseline was correlated with the disease duration of the patients (p=0.005 R:0.66). The PSQI score at baseline was significantly associated with a high total UPDRS and HADS score (p=0.03, p=0.004 respectively). There were no significant differences in terms of NMS-Quest total and subdomains thereof and PSQI total score and subdomains thereof, UPDRS-part I, BDI-II and HADS scores between baseline and 12 months post-DBS surgery (p&amp;gt;0.05 for all of them). Conclusion: STN-DBS surgery did not change subjective sleep quality, excessive daytime sleepiness, and NMS although it improved motor symptoms, motor fluctuations, and the health-related quality of life

Residual excessive daytime sleepiness in patients with sleep apnea syndrome receiving continuous positive airway pressure in Japan: A single-center study

Excessive daytime sleepiness (EDS) is a symptom of sleep apnea syndrome (SAS). In some patients with SAS who undergo continuous positive airway pressure (CPAP) therapy, EDS persists (residual EDS). However, knowledge of residual EDS in Japan is limited. Therefore, we examined EDS as defined by the Japanese version of the Epworth Sleepiness Scale (a score of ≥11) before and after long-term (≥1 year) CPAP therapy in 490 patients with SAS. Good adherence to CPAP therapy was defined as its use for at least 4 h during 70% of the nights. The prevalence of residual EDS was 9.4%. Residual EDS was negatively associated with good adherence to CPAP therapy. Furthermore, the longer the CPAP therapy duration after initiation, the lower the prevalence of residual EDS. Therefore, the findings on the prevalence of residual EDS and its association with CPAP therapy in Japan are probably similar to those of other countries.

Objective and Subjective Assessment of the Effect of Levetiracetam on Daytime Sleepiness in Patients with Epilepsy

Objective and Subjective Assessment of the Effect of Levetiracetam on Daytime Sleepiness in Patients with Epilepsy

0590 Effect of a whole-food plant-based diet on daytime sleepiness in patients with obstructive sleep apnea

Abstract Introduction Consumption of diet rich in high saturated fats has been associated with a higher degree of daytime sleepiness. A whole-food, plant-based (WFPB) dietary pattern, which is low in saturated fat, has been shown to be beneficial in weight loss and other health conditions. Patients with obstructive sleep apnea (OSA) frequently experience excessive daytime sleepiness despite treatment. This study aims to assess the effect of a short term (21 days) WFPB diet on daytime sleepiness in patients with obstructive sleep apnea. Methods Patients were recruited from the Mayo Clinic Jacksonville sleep clinic who have a diagnosis of OSA who are on PAP therapy but have daytime sleepiness with Epworth Sleepiness Scale (ESS) score of 5 or above. Participants were asked to follow a strict WFPB diet for 21 days using the Fork Over Knives handbook as a guide. They were also asked to complete ESS before switching to and after completing a WFPB diet for 21 days. Results A total of 10 participants completed the 21-day WFPB diet. Eight out of ten participants had reported a reduction in daytime sleepiness. Overall, we found a mean decrease in ESS score of 3.8 in all participants, with 3 patients had a significant decrease in ESS score of ≥ 7. All participants completed the study with ≥ 90% adherence to a WFPB diet. In addition, participants also reported a mean weight loss of 4.2 kg. Two participants noted headaches during this 21-day period. Conclusion Significant improvement with daytime sleepiness was found in patients who switched to a WFPB diet for 21 days. No significant correlation between improvement in ESS and weight loss was found. Support (if any)

0611 Treatment Satisfaction and Preferences in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate

Abstract Introduction Lower-sodium oxybate (LXB; Xywav®), which contains the same active moiety as higher-sodium oxybate (SXB; Xyrem®) but with 92% less sodium, is approved by the US Food and Drug Administration (FDA) for treating cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. LXB is recognized as clinically superior to SXB in narcolepsy by the US FDA due to lower chronic sodium exposure; however, real-world data describing patient preferences and satisfaction are lacking. Methods Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR; NCT04803786) was a patient-centric, prospective, observational, noninterventional, virtual-format study of US adults with narcolepsy (type 1 or 2) transitioning from SXB to LXB within the previous/upcoming 7 days. Longitudinal data collected during transition and for 21 weeks thereafter included responses to the Ease of Switching Medications Scale (EOSMS), Forced Preference Questionnaire (FPQ), and Treatment Satisfaction Questionnaire for Medication-version II (TSQM-vII). Results The mean (standard deviation [SD]) age of the 85 participants (narcolepsy type 1, n=45; narcolepsy type 2, n=40) was 40.3 (13.0) years; most were female (73%) and White (87%). Mean (SD) time on current SXB regimen was 57.8 (52.1) months. Nearly all participants took SXB (82/85, 96%) twice nightly prior to transition and LXB (82/84, 98%) twice nightly after transition. Most participants (61/73, 84%) reported that switching from SXB to LXB was “extremely easy, not difficult at all” or “easy” on the EOSMS, and most (59/73, 81%) preferred LXB to SXB on the FPQ. Among participants who preferred LXB, lower sodium content (56/59, 95%) and fewer cardiovascular issues (27/59, 46%) were cited as the most common reasons. There were minimal mean (SD) changes in TSQM-vII scores for global satisfaction (1.1 [18.6]), satisfaction with effectiveness (1.0 [16.8]), side effects (4.1 [23.7]), or convenience (−3.9 [15.2]) after transitioning from SXB to LXB. Conclusion Overall, most participants indicated that switching from SXB to LXB was “easy” or “extremely easy.” Most participants preferred LXB to SXB, primarily because of its lower sodium content. Satisfaction with oxybate treatment was maintained following transition to LXB. Support (if any) Jazz Pharmaceuticals

0598 Patient-Reported Sleep Quality in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate

Abstract Introduction Lower-sodium oxybate (LXB; Xywav®), which contains the same active moiety as higher-sodium oxybate (SXB; Xyrem®) but with 92% less sodium, is approved by the US Food and Drug Administration (FDA) for treating cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. LXB is recognized as clinically superior to SXB in narcolepsy by the US FDA due to lower chronic sodium exposure. Real-world data related to sleep quality following transition from SXB to LXB are lacking. Methods Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR; NCT04803786) was a patient-centric, prospective, observational, noninterventional, virtual-format study of US adults with narcolepsy (type 1 or 2) transitioning from SXB to LXB within the previous/upcoming 7 days. Longitudinal data collected during transition and for 21 weeks thereafter were based on daily and weekly questionnaires and sleep diaries instructing participants to rate the quality of their sleep and how refreshed they felt upon waking, and to record their sleep latency, wake after sleep onset (WASO), time in bed (TIB), and total sleep time (TST). Results The mean (standard deviation [SD]) age of the 85 participants (narcolepsy type 1, n=45; narcolepsy type 2, n=40) was 40.3 (13.0) years; most were female (73%) and White (87%). Almost all participants took SXB (82/85, 96%) twice nightly prior to transition and LXB (82/84, 98%) twice nightly after transition. Most participants rated their sleep quality as “good” or “very good” at baseline (45/84, 54%) and end of study (38/71, 54%), while 24/84 (29%) and 30/71 (42%) reported feeling “well-rested” or “very well-rested” at baseline and end of study, respectively. At end of study, changes (n=71) in mean (SD) sleep latency, WASO, TIB, and TST were −10.5 (16.2), −14.8 (56.6), 7.6 (67.7), and 33.0 (93.8) minutes, respectively. Conclusion Although participant-reported sleep quality was generally unchanged during the study, a greater percentage of participants reported feeling refreshed at end of study (on LXB) than at baseline (on SXB); however, there was no non-transitioning arm for comparison. Small changes were noted at end of study in sleep parameters, including sleep latency, WASO, and TST. Support (if any) Jazz Pharmaceuticals

0591 Effectiveness and Optimization of Lower-Sodium Oxybate in Participants With Narcolepsy Switching From Sodium Oxybate (SEGUE)

Abstract Introduction Lower-sodium oxybate (LXB, Xywav®) contains 92% less sodium than higher-sodium oxybate (SXB, Xyrem®) and is approved for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy (≥7 years of age) and idiopathic hypersomnia in adults. The SEGUE study examines the safety, tolerability, effectiveness, and treatment optimization in participants with narcolepsy transitioning from SXB to LXB. Methods Eligible participants in this multicenter, open-label study were adults with narcolepsy type 1 or 2 who were on a stable dose (maximum 9 g/night; no single dose &amp;gt;6 g) and regimen (once, twice, or thrice nightly) of SXB. After 2 weeks on a stable SXB dose/regimen (baseline period), participants switched to the same dose/regimen of LXB (intervention period; 6 weeks). If needed, LXB dose/regimen was titrated to optimize efficacy/tolerability. Assessments included the Patient Global Impression of Change (PGIc), a forced preference questionnaire (FPQ), an ease of switching medication scale (EOSMS), and the Epworth Sleepiness Scale (ESS); all collected at end of treatment or early discontinuation. Results Of 60 participants who entered the intervention period, a majority were female (62%) and White (88%); mean (SD) age was 43.9 (15.33) years. Starting and ending (end of treatment or early discontinuation) median total nightly doses of LXB were 8.5 g and 9.0 g, respectively. In terms of regimen, most took LXB twice nightly (93% at both time points). Fifty-six participants completed the transition period; mean (SD) time to stable dose was 2.5 (4.82) days, and median (range) number of changes in dose/regimen was 0.0 (0, 1). At end of treatment or early discontinuation, most participants reported improvement (very much/much/minimal; 45%) or no change (48%) in narcolepsy symptoms on the PGIc, preferred LXB over SXB on the FPQ (79%), and reported the transition to LXB was easy, extremely easy, or not difficult at all on the EOSMS (93%). Mean (SD) change from baseline on the ESS (n=55) was −0.7 (2.31). Conclusion Most participants with narcolepsy switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy. Effectiveness of oxybate treatment (ESS) was maintained after transition, and most preferred LXB over SXB. Support (if any) Jazz Pharmaceuticals.

0609 Samelisant, Histamine 3 Receptor Agonist for the Potential Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy

Abstract Introduction Samelisant (SUVN-G3031) is a potent and selective histamine 3 receptor inverse agonist. In orexin knockout mice, samelisant produced wake-promoting and anticataplectic effects suggesting its potential therapeutic utility in the treatment of narcolepsy. Safety and tolerability studies in animals and healthy human volunteers suggested a favorable risk/benefit profile for samelisant. Methods Samelisant is currently being evaluated in a double blind, Phase-2 proof of concept study in USA and Canada for narcolepsy with or without cataplexy (ClinicalTrials.gov Identifier: NCT04072380). The study is recruiting subjects diagnosed with narcolepsy as per ICSD-3 criteria, aged between 18 to 65 years with an Epworth Sleepiness Scale (ESS) score of ≥12 and mean Maintenance of Wakefulness Test (MWT) time of &amp;lt; 12 min. A total of 171 subjects are expected to be randomized into 3 treatment arms (placebo, samelisant 2 mg and samelisant 4 mg) in 1:1:1 ratio. Each subject will receive either placebo or study drug once daily for 2 weeks. The primary efficacy endpoint is change in MWT score from baseline to week 2. Key secondary endpoint is change in ESS from baseline to week 2. Safety will be monitored throughout the study by medical monitor and by data safety monitoring committee. As the study is still recruiting, demographics and baseline characteristic data for the currently enrolled subjects is summarized descriptively. Since the study is blinded, a breakdown of baseline characteristics by treatment group will not be available until after completion. Results At the data cutoff date of Nov 30, 2022, a total of 155 subjects were randomized in the study. The median age of subjects was 30 years (range: 18-57 years) with mean BMI of 28.5 kg/m2 (range: 18.3- 43.9 kg/m2). Overall, 57% subjects were of narcolepsy type-1, 71% were female and 71% were Caucasian. Mean (SD) baseline values of MWT and ESS scores were 6.1 (4.4) and 17.2 (2.8), respectively. Conclusion Baseline characteristics are consistent with the general narcolepsy population. The study is currently enrolling subjects with narcolepsy and the data readout is expected in Q2 2023. Support (if any)

Whole-food plant-based diet reduces daytime sleepiness in patients with OSA

Consumption of a diet high in saturated fat has been associated with daytime sleepiness. A whole-food plant-based (WFPB) dietary pattern, which is low in saturated fat, has been shown to be beneficial in a variety of health conditions. We assessed the effect of a short-term (21 days) WFPB diet intervention on daytime sleepiness in 14 patients with obstructive sleep apnea (OSA). We found a mean decrease of 3.8 points (SD = 3.3, p = 0.003) on the Epworth Sleepiness Scale (ESS) after switching from a standard Western diet to a WFPB diet. Our results suggest that a WFPB diet could be a viable dietary intervention to reduce symptom of daytime sleepiness.

Health-related impact of illness associated with excessive daytime sleepiness in patients with obstructive sleep apnea

ABSTRACT Objectives This real-world study aimed to characterize the impact of illness of excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea (OSA) who are adherent to continuous positive airway pressure (CPAP). Methods This cross-sectional study surveyed participants in Evidation Health’s Achievement app (November 2020–January 2021), a mobile consumer platform that encourages users to develop healthy habits and provides incentives to participate in research. Participants were US-resident adults who self-reported a physician diagnosis of OSA and adherence to CPAP (≥4 hours/night, ≥5 nights/week) for≥6 months. The survey included the Functional Outcomes of Sleep Questionnaire-Short Version (FOSQ-10), Epworth Sleepiness Scale (ESS), and questions regarding comorbidities, CPAP use, caffeine consumption, and physical activity. EDS was defined as ESS score >10. There were more female than male participants; therefore, data were reported separately for females/males. Results In total, 476 participants (female, n = 283 [59%]; mean [SD] age, 49.7 [10.8] years; obese, 74.4%) completed the survey; 209 had EDS (mean [SD] ESS, 13.8 [2.5]) and 267 did not (mean [SD] ESS, 6.3 [2.5]). Self-reported duration of CPAP use was consistent between the EDS/no EDS cohorts, with most participants using CPAP for 7 to 9 hours/night, 7 nights/week. Participants with EDS commonly reported anxiety ([EDS/no EDS] males: 31.5%/20.0%; females: 53.7%/39.5%), depression (males: 35.6%/24.2%; females: 55.9%/44.9%), and insomnia (males: 19.2%/6.7%; females: 25.7%/12.9%) and showed impairment on the FOSQ-10 ([EDS/no EDS] males: 80.8%/35.0%; females: 91.9%/53.1%). Participants with EDS reported that sleepiness ‘very often’ prevented physical activity and influenced dietary choices. Conclusion EDS influences choices related to physical activity, caffeine consumption, and diet in patients who are adherent with CPAP. More research is needed to understand the association between EDS and choices of CPAP-adherent patients. Future research should explore the health-related consequences of residual EDS associated with OSA and whether they can be mitigated by improving EDS.

Web Exclusive. Annals Video Summary - Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With OSA.

Web Exclusive. Annals Video Summary - Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With OSA.

Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea : A Systematic Review and Network Meta-analysis.

Excessive daytime sleepiness (EDS) is common among patients with obstructive sleep apnea (OSA). The comparative effectiveness of pharmacologic agents is unknown. To compare the effectiveness of drugs for EDS in OSA using network meta-analysis. MEDLINE, CENTRAL, EMBASE, and ClinicalTrials.gov to 7 November 2022. Reviewers identified randomized trials that enrolled patients with EDS-associated OSA on or eligible for conventional therapy assigned to any pharmacologic intervention. Paired reviewers independently extracted data addressing effects of drugs on the Epworth Sleepiness Scale (ESS), Maintenance of Wakefulness Test (MWT), and adverse events at the longest reported follow-up. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Fourteen trials (3085 patients) were eligible. At 4 weeks, compared with placebo, solriamfetol improves ESS scores (mean difference [MD], -3.85 [95% CI, -5.24 to -2.50]; high certainty), and armodafinil-modafinil (MD, -2.25 [CI, -2.85 to -1.64]; moderate certainty) and pitolisant-H3-autoreceptor blockers (MD, -2.78 [CI, -4.03 to -1.51]; moderate certainty) probably improve ESS scores. At 4 weeks, compared with placebo, solriamfetol (standardized mean difference [SMD], 0.9 [CI, 0.64 to 1.17]) and armodafinil-modafinil (SMD, 0.41 [CI, 0.27 to 0.55]) improve MWT (both high certainty), whereas pitolisant-H3-autoreceptor blockers probably do not (moderate certainty). At 4 weeks, armodafinil-modafinil probably increases the risk for discontinuation due to adverse events (relative risk [RR], 2.01 [CI, 1.14 to 3.51]; moderate certainty); solriamfetol may increase the risk for discontinuation due to adverse events (RR, 2.07 [CI, 0.67 to 6.25]; low certainty). Low certainty evidence suggests these interventions may not increase the risk for serious adverse events. There is limited evidence on long term or effectiveness among patients nonadherent or with mixed adherence to conventional OSA therapies. Solriamfetol, armodafinil-modafinil, and pitolisant reduce daytime sleepiness for patients with OSA already on conventional therapy, with solriamfetol likely superior. Adverse events probably increase the risk for discontinuation of armodafinil-modafinil and may increase the risk for discontinuation with solriamfetol. None.

Changes in cognitive function and daytime sleepiness in patients with chronic heart failure and Cheyne-Stokes respiration with adaptive servo ventilation treatment

Study objectivesCheyne - Stokes respiration (CSR) is prevalent in patients with chronic heart failure (CHF). Adaptive Servo Ventilation (ASV) alleviates CSR and improves objective sleep quality. We investigated the effects of ASV on neurocognitive function in the symptomatic phenotype of patients with CSR and CHF. MethodsThis case series included patients diagnosed with stable CHF (NYHA ≥ II) and CSR (N = 8). Sleep and neurocognitive function were assessed at baseline and after 1- and 6-months following initiation of ASV treatment. ResultsIn CHF patients (n = 8, median age 78.0[64.5–80.8] years and BMI 30.0[27.0–31.5] kg/m2, median ejection fraction 30[24–45]%, Epworth Sleepiness Scale (ESS) score 11.5[9.0–15.0]), ASV markedly improved respiration during sleep (Apnea-Hypopnea Index (AHI) 44.1[39.0–51.5]n/h at baseline, 6.3[2.4–9.7]n/h at 6 months treatment, respectively, p < 0.01). The 6-min-walk test distance increased by treatment from (295.0[178.8–385.0] m to 356.0[203.8–495.0] m (p = 0.05)). Sleep structure was modified, and Stage 3 increased markedly from 6.4[1.7–20.1] % to 20.8[14.2–25.3] %, p < 0.02). Sleep latency in the Maintenance of Wakefulness Test increased from 12.0[6.0–30.0] min to 26.3[12.0–30.0] min, (p = 0.04). In the Attention Network Test, evaluating neurocognition, the number of lapses decreased from 6.0[1.0–44.0] to 2.0[0.3–8.0], (p = 0.05) and the overall number of responses to a preset stimulus increased after treatment (p = 0.04). ConclusionsASV treatment in CHF patients with CSR may improve sleep quality, neurocognition and daytime performance.

Effectiveness of levocetirizine in treating allergic rhinitis while retaining work efficiency

The manifestation and severity of Allergic rhinitis symptoms show diurnal variation which negatively impacts the patient’s quality of life, day-to-day activities, and productivity at the workplace. The symptoms worsen at night or early morning and therefore administration of levocetirizine towards evening may be more acceptable. Consequently, the present study evaluated the effectiveness of evening Levocetirizine administration on 24-hour symptom control, Physical and mental health, and daytime somnolence in patients with allergic rhinitis the study was a prospective, open-labeled, single-arm, two-center, observational study among patients with allergic rhinitis. Levocetirizine was prescribed as 5 mg or 10 mg once a day evening oral dose for at least 7 days before sleep. The 24-hour total nasal symptom scores (TNSS) for self-reported signs and symptoms of allergic rhinitis were recorded. Additionally, study evaluations included the SF-12 scale (Quality of Life), Stanford Sleepiness Scale (degree of sleepiness), and work productivity and activity impairment (WPAI) questionnaires. These evaluations were performed at baseline (Day 0) and at scheduled intervals of Day 1 (24-hour), Day 3, and Day 7. Results demonstrated that evening administration of Levocetirizine facilitates 24-hour symptom control while having no significant effect on daytime somnolence, daily activities, and the work productivity of patients.