Epworth Sleepiness Scale Score Research Articles

0972 The Utility of CSF Orexin Testing in Investigating for Narcolepsy Type-1 in a Patient with Diencephalic Mass

Abstract Introduction Narcolepsy type 1 (NT1) is characterized by pathologic hypersomnolence, REM intrusion phenomena, including cataplexy, and orexin deficiency. The diagnosis of NT1 is established based on the presence of bone fide cataplexy and supportive PSG and MSLT testing which requires patients to achieve sufficient sleep duration and regularity and discontinue centrally acting medications that might alter REM sleep. In cases where there is a high index of suspicion for NT1, CSF orexin deficiency is helpful to support the diagnosis of NT1. This is particularly true when PSG-MSLT are not feasible, CNS medication cannot be discontinued, or cataplexy cannot be validated. Report of case(s) A 16 year old girl presented for evaluation of excessive daytime sleepiness in the setting of suprasellar germinoma which was resected and treated with chemoradiation at age 11. She subsequently developed panhypopituitarism and severe hypersomnolence in the setting of sleep-wake schedule irregularities, variability of sleep duration, refractory delayed sleep phase disorder, and snoring. She reported episodic weakness in the setting of negative triggers, which was atypical for cataplexy. Her medications included modafinil, amphetamine-dextroamphetamine, and the SSRI fluoxetine. Physical examination depicted normal airways. Epworth Sleepiness Scale score was 18. Screening polysomnography showed a sleep efficiency of 78%, sleep latency of 46.5 minutes, REM latency 2 hours, AHI of 0/hr, and periodic limb movements of 35/hr without arousals. While the REM latency on polysomnography was inconsistent with NT1, the clinical history of a diencephalic mass and chemoradiation was suggestive of secondary NT1. She was unable to proceed with PSG-MSLT due to her psychiatrist's advice against discontinuing her SSRI and her difficulty in maintaining sleep-wake regularity. An evaluation for CSF orexin was performed establishing a normal level of 337 pg/mL (reference level of 200 pg/mL in healthy individuals), ruling out orexin deficiency /narcolepsy type 1. The patient was subsequently improved with wake-promoting antidepressants and light therapy in the AM. Conclusion This case illustrates the value of CSF orexin testing in the setting of diencephalic lesions in patients unable to undergo formal narcolepsy testing. Support (if any)

0603 Characterization of Patients Who Had ≥5% Weight Loss With FT218 (Once-Nightly Sodium Oxybate): Post Hoc Analysis From REST-ON

Abstract Introduction Narcolepsy, particularly type 1 (NT1), is often comorbid with obesity. FT218 (LUMRYZ™) is an investigational once-nightly sodium oxybate (ON-SXB) formulation whose efficacy and safety were shown in the phase 3 REST-ON clinical trial (NCT02720744). Methods REST-ON was a 13-week, randomized (1:1), double-blind, placebo-controlled multicenter study in patients ≥16 years old with NT1/NT2. Stable concomitant stimulant use was permitted. A post hoc analysis of participants in the ON-SXB group experiencing ≥5% weight loss (weight-loss group) was conducted. Results In REST-ON (n=212), mean participant age was 31.2 years (range, 16–72), 67.9% were female, 75.5% were white, 76.4% had NT1, mean baseline BMI was 28.1 kg/m2 (range, 16.9–71.9), and 61.3% were taking stimulants. At week 13, 17.8% (19/107) of participants receiving ON-SXB experienced ≥5% weight loss vs 3.8% (4/105) of participants receiving placebo (P< 0.001). Compared to the REST-ON population, the weight-loss group had similar age and proportion of NT1 diagnosis, a smaller proportion was female, and a higher proportion was white and was taking stimulants. At baseline, mean BMI was 25.6 kg/m2 (range, 20.3–34.0) in the weight-loss group, 47.4% (9/19) were overweight (BMI 25.0–29.9 kg/m2) or obese (BMI >30 kg/m2); none were underweight (BMI < 18.5 kg/m2). At week 13, 31.6% (6/19) remained overweight or obese; none were underweight. Excessive daytime sleepiness was significantly improved from baseline to week 13 (ON-SXB 9 g) in the weight-loss group vs the ON-SXB group without weight loss (Maintenance of Wakefulness test, P< 0.05; Epworth Sleepiness Scale score, P< 0.001). Adverse events of nausea and vomiting were more frequent in the weight-loss group vs the ON-SXB group without weight loss; however, rate of discontinuations owing to AEs in the weight-loss group was approximately half that of the ON-SXB group without weight loss. Conclusion These data expand the body of knowledge regarding weight loss during treatment with sodium oxybate. Given the high proportion of comorbid obesity among people with narcolepsy, the additional benefit of potential weight loss with sodium oxybate may further inform treatment selection. Whereas ON-SXB was effective overall, further exploration of possible increased pharmacologic response in certain subgroups should be evaluated. Support (if any) Avadel Pharmaceuticals

0585 A four-week randomized, double-blind, placebo-controlled, phase 2 study of mazindol ER in the treatment of narcolepsy

Abstract Introduction Mazindol is the first partial orexin 2 receptor agonist and triple monoamine reuptake inhibitor in development for the treatment of narcolepsy. A novel extended release (ER) formulation was developed to allow once-daily dosing and may provide a differentiated treatment option. (ClinicalTrials.gov Identifier: NCT04923594). Methods Study NLS-1021 was a Phase 2, four-week, double-blind, randomized, placebo-controlled study of mazindol ER (NLS-2) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy type 1 (NT1) or type 2 (NT2). Efficacy, safety, tolerability, and pharmacokinetics were assessed. Adult subjects diagnosed with NT1 or NT2 and washed out of narcolepsy medications at baseline were randomized 1:1 to receive placebo or 2 mg mazindol ER once-daily for one week followed by 3 mg once-daily for three weeks. The primary efficacy endpoint was the change from baseline at Week 4 in excessive daytime sleepiness using the Epworth Sleepiness Scale (ESS). Secondary efficacy endpoints included improvement in weekly cataplexy attacks and overall disease severity as rated by the investigators (Clinician Global Impression of Severity; CGI-S) and patients (Patient Global Impression of Severity; PGI-S). Results Sixty-seven subjects were randomized (n = 33 NLS-2; 34 placebo). The baseline mean [SD] ESS score was 17.9 [2.97] in subjects receiving NLS-2 and 18.0 [3.05] in placebo. NLS-2 met the pre-specified primary endpoint, demonstrating a statistically significant improvement in EDS with a least-squares mean [SE] difference (NLS-2-placebo) of –3.6 [1.33] in the ESS total score at Week 4 (p = 0.0081). Observed mean change from baseline in ESS total score was –7.1 [5.6] for NLS-2 and –3.2 [5.3] for placebo. In NT1 subjects, baseline weekly number of cataplexy episodes was 14.1 [10.8] in subjects receiving NLS-2 (n=11) and 15.0 [10.2] in placebo (n=12). At Week 4, the weekly number of cataplexy episodes was reduced to 4.1 with NLS-2 and to 8.5 with placebo. NLS-2 was generally safe and well-tolerated with no severe or serious adverse events or discontinuations due to adverse events. Conclusion In subjects with narcolepsy, NLS-2 significantly improved EDS and the number of cataplexy attacks compared with placebo. Support (if any) NLS Pharmaceutics

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)

Efficacy of Once-Nightly Sodium Oxybate (FT218) in Narcolepsy Type 1 and Type 2: Post Hoc Analysis From the Phase 3 REST-ON Trial.

Post hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1) and 2 (NT2). Participants were stratified by narcolepsy type and randomized 1:1 to ON-SXB (4.5g, week 1; 6g, weeks 2-3; 7.5g, weeks 4-8; and 9g, weeks 9-13) or placebo. Assessments included mean sleep latency on Maintenance of Wakefulness Test (MWT) and Clinical Global Impression-Improvement (CGI-I) rating (coprimary endpoints) and sleep stage shifts, nocturnal arousals, and patient-reported sleep quality, refreshing nature of sleep, and Epworth Sleepiness Scale (ESS) score (secondary endpoints) separately in NT1 and NT2 subgroups. The modified intent-to-treat population comprised 190 participants (NT1, n=145; NT2, n=45). Significant improvements were demonstrated with ON-SXB vs placebo in sleep latency for NT1 (all doses, P<0.001) and NT2 (6 and 9g, P<0.05) subgroups. Greater proportions of participants in both subgroups had CGI-I ratings of much/very much improved with ON-SXB vs placebo. Sleep stage shifts and sleep quality significantly improved in both subgroups (all doses vs placebo, P<0.001). Significant improvements with all ON-SXB doses vs placebo in refreshing nature of sleep (P<0.001), nocturnal arousals (P<0.05), and ESS scores (P≤0.001) were reported for NT1 with directional improvements for NT2. Clinically meaningful improvements of a single ON-SXB bedtime dose were shown for daytime sleepiness and DNS in NT1 and NT2, with less power for the limited NT2 subgroup.

0173 Improving Well-being by Changing the Shiftwork Schedules at U.S. Navy Watchfloors

Abstract Introduction Watchfloors provide around-the-clock information, intelligence, and technical support to the U.S. military. Active-duty service members (ADSMs) working on these 24/7 watchfloors stand watches to include night shifts and/or frequent shift rotations. Tailoring shiftwork schedules to optimize individual sleep patterns may reduce the negative effects of shiftwork. The purpose of this study was to test whether a new shiftwork schedule would improve ADSM well-being and sleep. Methods ADSMs (N=79; 83.5% males, 91.2% enlisted, 19 to 54 years of age) participated in a two-phase quasi-experimental longitudinal study to assess well-being and sleep before and after the implementation of a new shiftwork schedule. Both schedules involved three rotating shifts: day shift (0730-1530), evening shift (1320-2330), and night shift (2330-0730). The old schedule had 5 successive days on-shift (5-on/4-off) and the new schedule had 4 successive days on-shift (4-on/4-off). Shifts rotated after every off period. Standardized questionnaires were administered while participants were on the old schedule (study start) and ~5 months after switching to the new schedule. The questionnaires included the Pittsburg Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), the Epworth Sleepiness Scale (ESS), and the Profile of Mood States (POMS). Sleep was monitored using wearable devices (ŌURA rings). Results POMS total mood disturbance scores were lower (i.e., better) on the new schedule (p&amp;lt; 0.001), as were several POMS sub-scale scores including tension (p&amp;lt; 0.001), depression (p&amp;lt; 0.001), anger (p=0.014), confusion (p&amp;lt; 0.001), and vigor (p=0.029). There was a statistical trend for a decrease in ISI scores from the old schedule to the new schedule (p=0.067). Sleep duration, PSQI, and ESS scores did not differ between schedules (all p&amp;gt;0.05). Conclusion Implementation of a new shiftwork schedule that was tailored to worker sleep patterns was associated with decreased mood disturbance, improvement in negative mood states (e.g., depression and tension), and reduced insomnia symptom severity. Also, the research team received several anecdotal reports of high levels of worker satisfaction with the new schedule. This study demonstrates the positive real-world effects of using basic sleep and circadian methods to tailor shiftwork schedules to improve the well-being of military personnel. Support (if any)

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)

0408 Insomnia, hypersomnia, and depression in buprenorphine treated opioid use disorder subjects

Abstract Introduction Sleep disturbances and depression are highly prevalent in Opioid use disorder subjects treated with buprenorphine. However, the association between sleep disturbances such as insomnia/hypersomnia and depression in the above patient population is not known. The aim of the study is to examine the association between sleep disturbances including insomnia and hypersomnia with depressive disorders in buprenorphine treated opioid use disorder (OUDB) subjects. Methods We studied 92 OUDB (38±11.2y, 49% female, 9% minority) at the Recovery, Advocacy, Empowerment and Service program (RASE) and Internal Medicine clinics of Wellspan (York, PA). Subjects completed the Patient Health Questionaire-9 (PHQ-9), Insomnia Severity Index (ISI), Epworth sleepiness scale (ESS), and opioid craving scale (OCS). Depression was defined as a PHQ 9 score ≥ 10, insomnia with an ISI score of &amp;gt;15 and excessive daytime sleepiness (EDS) with an ESS score of &amp;gt;10. Binary logistic regression analysis evaluated the likelihood of OUDB subjects having depression in relation to insomnia, excessive daytime sleepiness (EDS), opioid craving, duration of opioid use, duration since last use of any illegal substance, number of rehabilitation treatments and buprenorphine dosage. Results No differences between in OUDB subjects with (n=47) and without (n=34) depression were observed in age, duration of opioid dependence, duration of buprenorphine treatment, number of rehabilitation treatments or time since last use of any illegal substance. Subjects with depression had significantly higher ISI (18.2±4.2 verus11.8±6.6, p&amp;lt; 0.01), ESS (11.2±4.7 versus 8.2±4.1, p&amp;lt; 0.01 ) scores and a trend towards higher OCS score (3.2±4.1 verus1.9±2.2, p=0.056) as compared to those without depression. The odds of depression associated with Insomnia and EDS were 8.5 (95%CI=2.3-31.2) and 4.4 (95%CI=1.1-17) times respectively in this patient population. Conclusion Insomnia and hypersomnia are highly associated with depression in buprenorphine treated OUDBs patients. Insomnia and hypersomnia needs to be evaluated early and receive targeted treatment during early abstinence in order to prevent relapse in this patient population. Support (if any) This project is supported by the Junior Faculty Development Program, Penn State College of Medicine

0470 Factors Associated with Discordant Initial Home Sleep Apnea Testing and Polysomnography

Abstract Introduction Nocturnal polysomnography (PSG) is the gold standard for diagnosing obstructive sleep apnea (OSA). Home sleep apnea tests (HSAT) have been incorporated in the diagnostic algorithm in patients with a high pre-test suspicion of OSA. While many studies have compared HSATs with PSGs, it is not well understood what factors may be responsible for inconclusive HSAT results. Methods We performed a retrospective chart review of adult patients who underwent a non-diagnostic HSAT evaluation, who subsequently tested positive for OSA (on PSG) between 1/1/2022 and 11/1/2022. We collected demographic and sleep study data. Patients who did not have a follow up PSG were excluded. Results A total of 20 patients were reviewed. 80% had a negative HSAT with a positive subsequent PSG. The average age was 33.9 years (SD +/- 11.3 years). 43% were male and 50% were Caucasian. The average BMI was 29 kg/m2 (SD +/- 5.3 kg/m2). The average Epworth Sleepiness Scale score (ESS) was 8 (median 6.5) with only 31% reporting an ESS &amp;gt;10. The average HSAT recording time was 449.1 minutes. The average respiratory disturbance index (RDI) on the follow up PSG was 17.7 events/hour of sleep (SD +/- 12). Only 1 patient was diagnosed with severe OSA. 38% were diagnosed with anxiety in this cohort. Other co-morbidities were insignificant. Of all the HSATs performed, 40% were denied for an initial PSG evaluation and converted to an HSAT evaluation. Conclusion HSATs are validated in patients with a high pretest probability of OSA. Anxiety was found in one third of patients included (possibly contributing to a negative initial HSAT). Patient demographics however were also not remarkable for a high risk of OSA in this group (e.g. non-obese, &amp;lt; 55 years, female). The subsequent diagnosis for OSA was also only mild or moderate (93.8%) in this lower risk cohort. Hence, another explanation for the initial negative HSAT evaluation may have been the insurance denial of the initial PSG request (40%). Denials of low risk patients for PSG may contribute to a misuse of resources. We also need to educate referring physicians to follow appropriate HSAT ordering criteria (based on high OSA risk factors). Support (if any)

0419 Sensitivity of ORP to classify individuals with insomnia based on subjective complaints

Abstract Introduction The diagnosis of insomnia is currently based on subjective complaints. Previous research has demonstrated limited benefits of polysomnography in improving diagnostic accuracy with no evident differences in sleep macro-architecture and traditional indices of sleep quality. In this study, we aimed to assess the ability of a novel index of sleep quality, the Odds Ratio Product (ORP), to correctly identify individuals with insomnia, based on subjective complaints. Methods We analyzed responses to a custom sleep survey from 510 participants (age 46.2±12.4; 229 females). We entered 13 outcomes to a principal component analysis (PCA). These included age, body mass index (BMI), Epworth Sleepiness Scale (ESS) scores, sex, questions about snoring, subjective hours of sleep, satisfaction with own sleep, movement symptoms, problems falling asleep, staying asleep and waking up early. Based on the correlations between the original outcomes, the PCA extracted 3 factors that were interpreted as 3 different phenotypes: 1) insomnia (e.g., sleep initiation and maintenance complaints, satisfaction with sleep, lower subjective sleep duration); 2) OSA (e.g., bed partner snoring complaints, snoring self-awareness, sleepiness, respiratory complaints); 3) movement disorder (e.g., movements, female, lower age, higher BMI). We then computed the pre-test probability of insomnia (factor 1 scores &amp;gt;80%) and conducted a series of ROC analyses to assess specificity of PSG indices traditionally used to evaluate the presence of insomnia, and of ORP metrics. Results The AUC values assessing the ability of ORP metrics to predict 80% pre-test probability of insomnia were: ORPwake (0.592, 95% CI 0.499-0.685), ORPNREM (0.465, 95% CI 0.362-0.558), ORPREM (0.542, 95% CI 0.447-0.636), and ORPTRT (0.567, 95% CI 0.475-0.659). When looking at traditional indices like total sleep time (TST), wake after sleep onset (WASO), and number of awakenings, the AUC values were 0.471 (95% CI 0.385-0.556), 0.612 (95% CI 0.528-0.697) and 0.509 (95% CI 0.421-0.597), respectively. Conclusion WASO, ORPwake and ORPTRT have the highest sensitivity to detect insomnia in participants with &amp;gt;80% pretest probability measured by subjective complaints. These analyses indicate the value of EEG metrics of sleep quality to correctly identify individuals with insomnia and the need to investigate both sleep and wake states. Support (if any)

0542 Obstructive sleep apnea in outpatients with COPD at Can Tho University of Medicine and Pharmacy Hospital – An Observational Study

Abstract Introduction The concurrence of obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) is generally identified as overlap syndrome.This study evaluated biometric characteristics, sleep disorders, and scores comorbidities on OS and OSA groups in outpatients at the Respiratory Units of Can Tho University of Medicine and Pharmacy Hospital (RU-CTUMP); surveyed respiratory symptom severity, airway obstruction, and aerosol treatment characteristics in OS patients; and determined the correlations between sleep disorder severity and specific patient characteristics. Methods A cross-sectional, single-center descriptive study was conducted. We enrolled 48 outpatients at the RU-CTUMP in the study in three months. The patients were divided into two groups with overlapped COPD and OSA (OS, n = 30) vs. OSA-only (n = 18). Patients were asked to complete the demographic questionnaires, Epworth Sleepiness Scale (ESS) scores, STOP-Bang questionnaire, and Snoring Severity Scale (SSS). They were assessed for pulmonary function tests (PFTs) to confirm their COPD diagnosis, overnight respiratory polygraphy (Nox T3x), and Apnea-Hypopnea Index (AHI) to evaluate the severity of OSA, Charlson index to evaluate comorbidities, and their medication history. Results In the OS group, 100% of the patients suffered from dyspnea with the mean mMRC scores of 2.83 ± 0.75, mean FEV1 was 60.07 ± 23.09%, and 86% received inhaled medicine. In both groups, all participants suffered from 1 - ≥ 2 comorbidities. Overlapped patients had more comorbidities than OSA-only patients (Charlson scores of 2.33 and 1.17, respectively). There were significant correlations between the AHI value and the body mass index, neck circumferences, STOP-Bang score, the value of the Snoring Severity Scale, and minimum SpO2 (r = 0.45, 0.43, 0.46, 0.44, -0.69, respectively). In addition, COPD was a risk factor for OSA (OR = 1.125). Conclusion Home sleep testing in outpatients with COPD in RU-CTUMP revealed an increased prevalence of OSA compared to the OSA-only group. One of the most common comorbidities in individuals with overlap syndrome is hypertension, which is at least as common as in sleep apneic-only patients and may contribute to the disease's overall severity and prognosis. Support (if any)

0561 Solriamfetol Real World Experience Study: Safety, Efficacy, and Follow-Up for Patients with Obstructive Sleep Apnea in Germany

Abstract Introduction Excessive daytime sleepiness (EDS) is a symptom of Obstructive Sleep Apnea (OSA) that can persist despite primary airway therapy and can be managed with wake-promoting agents. Solriamfetol (Sunosi®) is a wake-promoting agent approved to treat EDS associated with OSA (37.5–150 mg/day). This real-world study characterizes dosing/titration strategies among European physicians initiating solriamfetol and patient outcomes following initiation. Methods This is an ongoing retrospective chart review conducted by physicians in Germany and France. Data are reported from 52 German patients with OSA. Eligible patients (≥18 years old, diagnosed with EDS due to OSA, reached a stable solriamfetol dose, and completed ≥6 weeks of treatment) were classified into 1 of 3 groups based on solriamfetol initiation strategy: changeover (switched/switching from existing EDS medication[s]), add-on (added/adding to current EDS medication[s]), or new-to-therapy (no current/previous EDS medication). Results Patients’ mean±SD age was 50.0±13.1 years; 65% were male. All patients used primary airway therapy. Obesity was the most common comorbidity (56%). New-to-therapy was the most common initiation strategy (n=39), then add-on (n=9), and changeover (n=4). The most common starting doses of solriamfetol were 37.5 (n=34; 65%) and 75 mg/day (n=17; 33%). Solriamfetol was titrated in 30 patients (58%); the majority were titrated within 7 days. Mean±SD Epworth Sleepiness Scale (ESS) score was 15.5±3.2 (n=52) at initiation and 10.7±3.7 at follow-up (n=48), with a mean decrease of 5.0± 3.2 points. Across subgroups, mean ESS scores at initiation and follow-up ranged from 15.2–16.8 and 10.3-11.6, with mean decreases from 4.5–6.5 points. Improvements in EDS after solriamfetol initiation were reported for most patients (patient-reported, 90%; physician-reported, 88%). Most patients reported the effects of Solriamfetol to last ≥6 hours (81%) with no change in their night-time sleep quality (86%). Common adverse effects were headache, insomnia, and irritability. Conclusion These real-world data describe the use of solriamfetol in a cohort of German patients with OSA. Solriamfetol was typically initiated at 37.5 mg/day; titration was common. ESS improvements were greater than the minimum clinically important difference (MCID) of 2-3, and most patients and physicians perceived improvement in EDS. Common adverse events were consistent with those previously reported for solriamfetol. Support (if any) Axsome Therapeutics and Jazz Pharmaceuticals

0854 Observation-based Diurnal Sleepiness Inventory (ODSI) is associated with Objective Sleepiness via Psychomotor Vigilance Task

Abstract Introduction The Epworth Sleepiness Scale (ESS) is commonly used to assess excessive daytime sleepiness, but its accuracy is limited. In this study, we aim to compare the ESS with the Observation-based Diurnal Sleepiness Inventory (ODSI), a subjective measure of sleepiness that has been validated using the ESS in older adults, to objective measures of sleepiness obtained through the Psychomotor Vigilance Task (PVT). Despite being validated with the ESS, the ODSI has not yet been tested with objective measures of sleepiness. By comparing subjective measures of sleepiness (ODSI and ESS) to objective measures (PVT), we aim to expand the usage of ODSI to other populations. Methods 91 persons with newly diagnosed obstructive sleep apnea and not yet treated on continuous positive airway pressure (CPAP) were administered the ESS, ODSI, and PVT sleepiness tests, and the results were analyzed for correlations using linear regression. The average age was 50.48 ± 12.74, the mean body mass index (BMI) was 35.9 ± 9.3, the mean apnea hypopnea index was 30.9 ± 23.7, and 53.5% were male. The ESS and ODSI scores were run against PVT lapses and transformed average reaction time, which are the two primary outcomes of PVT. Results PVT lapses were significantly different between sleepy and non-sleepy individuals as defined by both ESS and ODSI categorization. Both the ODSI and the ESS were significantly correlated to the transformed average reaction time. The second question on the ODSI was also significantly correlated to PVT lapses as well as the transformed average reaction time. Conclusion The ODSI and ESS correlated well with objective measures of sleepiness through the PVT. The ODSI is a suitable measure of sleepiness appropriate for usage in middle-aged adults with obstructive sleep apnea. Support (if any) R00NR014675-05 (PI: Pak)

0592 Efficacy of Lower-Sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Patients With Idiopathic Hypersomnia

Abstract Introduction Idiopathic hypersomnia is a debilitating neurologic sleep disorder. Sleep inertia (difficulty awakening) is a common symptom that can significantly impair functioning and quality of life. This post hoc analysis evaluated response to lower-sodium oxybate (LXB; Xywav®) by baseline sleep inertia in a phase 3 trial (NCT03533114). Methods Eligible participants began LXB treatment with an open-label treatment titration and optimization period (10–14 weeks), followed by a 2-week stable-dose period (SDP). Participants were randomized to placebo or continued LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). Using the visual analog scale for sleep inertia (VAS-SI), participants rated their difficulty awakening during baseline, SDP, and DBRWP on a 100-mm line with anchors at 0 (very easy) and 100 (very difficult). VAS-SI terciles comprised score segments of &amp;lt; 44 (group A), ≥44 to &amp;lt; 70 (group B), and ≥70 (group C). Efficacy assessments included the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Clinical Global Impression of Severity (CGIs), and Patient Global Impression of Change (PGIc). Results Participants (A, n=34; B, n=33; C, n=32) were a mean (SD) 40.7 (13.5) years of age and primarily female (74%). At baseline, participants with the highest VAS-SI scores had numerically higher mean (SD) ESS (A=16.0 [3.1], B=15.6 [2.6], C=17.1 [2.4]) and IHSS (A=26.7 [7.7], B=34.5 [5.9], C=36.3 [5.5]) scores. Participants with the highest baseline sleep inertia were more frequently rated severely ill on the CGIs (A=17.6%, B=12.1%, C=34.4%). Baseline total sleep time trended higher with increasing VAS-SI scores. From baseline to end of SDP, mean (SD) scores decreased (improved) on the ESS (A=−9.9 [5.1], B=−9.8 [3.5], C=−10.0 [5.1]) and IHSS (A=−14.1 [9.9], B=−19.0 [9.0], C=−18.1 [9.9]), regardless of baseline sleep inertia; nearly all (99%) participants reported improvement on the PGIc. Mean (SD) VAS-SI scores decreased by 9.3 (11.9), 31.5 (14.8), and 42.8 (22.9) in groups A, B, and C, respectively, at end of SDP. Spearman correlation coefficients for VAS-SI and IHSS items assessing sleep inertia were moderate (≥0.3) to strong (≥0.6). Conclusion Participants with higher baseline sleep inertia generally had greater baseline disease burden. LXB treatment was efficacious across subgroups regardless of baseline sleep inertia. Support (if any) Jazz Pharmaceuticals.

0381 Adverse Childhood Experiences Associated with Adult Sleep Duration, Control Over Sleep, and Daytime Sleepiness

Abstract Introduction Adverse childhood events have been linked with many mental and physical health risks, but less work has explored nighttime and daytime sleep problems, especially inability to control sleep. Methods Data were obtained from the Sleep and Healthy Activity, Diet, Environment, and Socialization (SHADES) study of N=1007 adults aged 22-60 years recruited from communities in southeastern Pennsylvania. Adverse childhood experiences were defined as a self-reported history of child abuse, parent divorce, parent death, parent with depression, parent with anxiety disorder, and childhood poverty (yes/no). Habitual sleep duration was assessed in hours, daytime sleepiness was assessed with the Epworth Sleepiness Scale (ESS), and control over sleep was assessed with the Brief Index of Sleep Control (BRISC). Covariates included age, sex, race/ethnicity, and education. Additional models included depression severity, assessed using a modified version of the Patient Health Questionnaire-9. Results History of child abuse was associated with 23 fewer minutes of nighttime sleep (p=0.001), and parent anxiety was associated with 15 fewer minutes (p=0.048). When depression was added to the model, the effects for sleep duration were attenuated (15.3 minutes, p=0.03). No other relationships were observed. Regarding control over nighttime sleep, decreased sense of control was reported by those who experienced child abuse (B=-0.4, p&amp;lt; 0.0005), parent divorce (B=-0.1, p=0.035), and parent depression (B=-0.2, p=0.02). After adjusting for depression, the relationship with child abuse was attenuated but maintained (B=-0.2, p&amp;lt; 0.0005). Elevated ESS scores were seen in those who reported child abuse (B=4.7, p&amp;lt; 0.0005), parent depression (B=4.3, p&amp;lt; 0.0005), and parent anxiety (B=3.9, p&amp;lt; 0.0005). After adjusting for depression, relationships were attenuated but maintained for child abuse (B=2.0, p=0.02), parent depression (B=2.2, p=0.004), and parent anxiety (B=2.2, p=0.017). Conclusion Adverse childhood events may lead to sleep/wake dysregulation, including less sleep at night, more sleepiness during the day, and decreased sense of control over sleep ability. Future efforts might focus on increasing control over nighttime sleep and reducing daytime sleepiness. Support (if any)

Association between daytime sleepiness and motor vehicle accidents among Japanese male taxi drivers

Although the Epworth Sleepiness Scale (ESS) is a scoring system commonly used to assess daytime sleepiness (DS), the association between ESS and motor vehicle accidents (MVAs) remains unclear. Therefore, we conducted a cross-sectional study to examine the association between an increase in the Japanese version of the ESS (JESS) scores and MVAs among Japanese male taxi drivers. The study participants were 1384 Japanese male taxi drivers. DS was assessed using the JESS, and the total JESS scores were categorized into quartile groups. MVA experience during the past five years was assessed using a self-administered questionnaire. A multivariable generalized linear model was used to examine the association between JESS and MVAs after adjusting for age, body mass index, smoking status, snoring, sleep duration, driving experience, driving distance per year, hypertension, and diabetes mellitus.The proportion of MVAs was 59.7%. The multivariable-adjusted prevalence ratio (95% confidence interval) of MVAs for the highest quartile of the JESS score was 1.16 (1.04–1.29) compared to the lowest quartile, and for continuous JESS score was 1.01 (1.002–1.02). Thus, we found a significant association between an increase in JESS scores and MVAs among Japanese male taxi drivers after adjusting for potential confounders. Stratification by sleep duration and snoring status revealed a significant association among long sleepers and non-snorers. Our findings suggest that ESS evaluation methods be reconsidered in relation to MVA among commercial drivers.

ISleepFirst: burnout, fatigue, and wearable-tracked sleep deprivation among residents staffing the medical intensive care unit.

This study aimed to evaluate the relationship between sleep, burnout, and psychomotor vigilance in residents working in the medical intensive care unit (ICU). A prospective cohort study of residents was implemented during a consecutive 4-week. Residents were recruited to wear a sleep tracker for 2weeks before and 2weeks during their medical ICU rotation. Data collected included wearable-tracked sleep minutes, Oldenburg burnout inventory (OBI) score, Epworth sleepiness scale (ESS), psychomotor vigilance testing, and American Academy of Sleep Medicine sleep diary. The primary outcome was sleep duration tracked by the wearable. The secondary outcomes were burnout, psychomotor vigilance (PVT), and perceived sleepiness. A total of 40 residents completed the study. The age range was 26-34years with 19 males. Total sleep minutes measured by the wearable decreased from 402min (95% CI: 377-427) before ICU to 389 (95% CI: 360-418) during ICU (p < 0.05). Residents overestimated sleep, logging 464min (95% CI: 452-476) before and 442 (95% CI: 430-454) during ICU. ESS scores increased from 5.93 (95% CI: 4.89, 7.07) to 8.33 (95% CI: 7.09,9.58) during ICU (p < 0.001). OBI scores increased from 34.5 (95% CI: 32.9-36.2) to 42.8 (95% CI: 40.7-45.0) (p < 0.001). PVT scores worsened with increased reaction time while on ICU rotation (348.5ms pre-ICU, 370.9ms post-ICU, p < 0.001). Resident ICU rotations are associated with decreased objective sleep and self-reported sleep. Residents overestimate sleep duration. Burnout and sleepiness increase and associated PVT scores worsen while working in the ICU. Institutions should ensure resident sleep and wellness checks during ICU rotation.

Clinical determinants of sleep quality in patients with amyotrophic lateral sclerosis.

Poor sleep quality is more prevalent in patients with amyotrophic lateral sclerosis (ALS) than in healthy populations. The purpose of this study was to examine whether or notmotor dysfunction at various distinct levels correlates with subjective sleep quality. Patients with ALS and controls were assessed using the Pittsburgh Sleep Quality Index (PSQI), ALS Functional Rating Scale Revised (ALSFRS-R), Beck Depression Inventory-II (BDI-II), and the Epworth Sleepiness Scale (ESS). The ALSFRS-R was used to obtain information on 12 different aspects of motor function in patients with ALS. We compared these data between the groups with poor and good sleep quality. A total of 92 patients with ALS and 92 age- and sex-matched controls entered the study. The global PSQI score was significantly higher in patients with ALS than in healthy subjects (5.5 ± 4.2 vs. 4.0 ± 2.8) and44% of the patients with ALShad poor sleep quality (PSQI score > 5). The sleep duration, sleep efficiency, and sleep disturbances components were significantly worse in patients with ALS. Sleep quality (PSQI) score correlated with ALSFRS-R score, BDI-II score, and ESS score. Of the 12 ALSFRS-R functions, swallowing significantly affected sleep quality. Orthopnea, speech, salivation, dyspnea, and walking had a medium effect. In addition, turning in bed, climbing stairs, and dressing and hygiene were found to have a small effect on sleep quality among patients with ALS. Nearly half of our patients had poor sleep quality related to disease severity, depression, and daytime sleepiness. Bulbar muscle dysfunction may be associated with sleep disturbances in individuals with ALS, particularly when swallowing is impaired. In addition, patients suffering from axial or lower limb muscle disruptions are likely to have trouble sleeping.

Insomnia during coronavirus disease 2019 pandemic in Korea: a National sleep survey.

Coronavirus disease 2019 (COVID-19) pandemic has caused widespread increase in stress and affected sleep quality and quantity, with up to 30% prevalence of sleep disorders being reported after the declaration of the pandemic. This study aimed to assess perceived changes due to the pandemic in the prevalence of insomnia and excessive daytime sleepiness (EDS) in Korea, and identify the associated factors. An online survey was conducted among 4000 participants (2035 men and 1965 women) aged 20-69years enrolled using stratified multistage random sampling according to age, sex, and residential area, between January, 2021 and February, 2022. The questionnaire included various items, such as socio-demographics, Insomnia Severity Index, and Epworth Sleepiness Scale (ESS). Insomnia was defined as difficulty falling asleep and difficulty maintaining sleep more than twice a week. EDS was classified as an ESS score ≥ 11. Insomnia was reported by 32.9% (n = 1316) of the participants (37.3% among women and 28.6% among men). Multivariate logistic regression revealed that insomnia was associated with female sex [odds ratio (OR) = 1.526, 95% confidence interval (CI) = 1.297-1.796], night workers (OR 1.561, 95% CI 1.160-2.101), and being unmarried (OR 1.256, 95% CI 1.007-1.566). EDS was reported by 12.8% (n = 510) of the participants (14.7% among men and 10.7% among women). EDS was associated with male sex (OR 1.333, 95% CI 1.062-1.674), and being employed (OR 1.292, 95% CI 1.017-1.641). During the COVID-19 pandemic, the prevalence of insomnia increased in Korea, while there was no significant change in EDS compared with pre-pandemic evidence.

Does orthognathic surgery have an incidentally beneficial effect on mild or asymptomatic sleep apnoea?

A prospective study was performed to assess the effect of orthognathic surgery on mild obstructive sleep apnoea (OSA) in patients with an underlying dentofacial deformity treated for occlusal and/or aesthetic reasons. As the main outcome variables, changes in upper airway volume and apnoea–hypopnoea index (AHI) were evaluated at 1 and 12 months of follow-up, in patients undergoing orthognathic surgery with widening movements of the maxillomandibular complex. Descriptive, bivariate, and correlation analyses were performed; significance was set at P < 0.05. Eighteen patients diagnosed with mild OSA were enroled (mean age 39.8 ± 10.0 years). An overall upper airway volume widening of 46.7% after orthognathic surgery was observed at 12 months of follow-up. The AHI decreased significantly from a median 7.7 events/hour preoperatively to 5.0 events/h at 12 months postoperative (P = 0.045), and the Epworth Sleepiness Scale score decreased from a median 9.5 preoperatively to 7 at 12 months postoperative (P = 0.009). A cure rate of 50% was obtained at 12 months of follow-up (P = 0.009). Despite the limited sample size, this study provides evidence that in patients with an underlying retrusive dentofacial deformity and mild OSA, a slight decrease in AHI is obtained after orthognathic surgery due to upper airway enlargement, which could be added as a beneficial effect of orthognathic surgery.