bluuebunny/crossref_metadata_2025_split huggingface dataset:
0405 Patient and Healthcare Provider Surveys of Narcolepsy Disease Burden and Oxybate Treatment Experience
Authors: Morse Anne Marie , Krahn Lois , Kushida Clete , Thorpy Michael , Flygare Julie , Seiden David , Athaval Amod , Gudeman Jennifer 
Published: May 2022

Abstract

Introduction
Immediate-release sodium oxybate (SXB) and mixed-salt oxybates require patients with narcolepsy to take a second nightly dose 2.5–4 h after the first. Extended-release, once-nightly SXB (ON-SXB; FT218) is an investigational treatment for adults with narcolepsy. Surveys evaluated patient and healthcare provider (HCP) perspectives on narcolepsy disease burden and satisfaction with current narcolepsy treatment options.

Methods
Individuals with narcolepsy and HCPs participated in 30-minute, web-based surveys. Participants were 1) adults with self-reported, physician-diagnosed narcolepsy for ≥1 year, and prior/current/no use immediate-release oxybates; and 2) board-certified/board-eligible HCPs (pulmonology, sleep medicine, neurology, psychiatry specialties); nurse practitioners; or physician assistants. Participants responded using 9-point scales; higher scores indicated greater severity/agreement/satisfaction/importance/preference.

Results
Mean patient participant (n=120) age was 40 years; most were white (81%), female (79%), and current/past users of twice-nightly SXB (n=86) or mixed-salt oxybates (n=56). Twenty-six were oxybate naive. Most HCPs (n=100; 68% male) had sleep medicine (37%) or neurology (30%) specialties; 91% and 83% had experience with twice-nightly SXB and mixed-salt oxybates, respectively. Patients and HCPs agreed that patients preferred narcolepsy treatments dosed fewer times (rated 6.7 and 7.7, respectively). Common symptoms patients experienced daily/almost daily at narcolepsy diagnosis were tiredness/fatigue (64%) and excessive daytime sleepiness (EDS; 68%). HCPs and patients expressed moderate-to-high satisfaction with mixed-salt oxybates (both 7.1) and twice-nightly SXB (6.8 and 6.6, respectively). Compared to HCPs, patients were less satisfied with modafinil (6.9 vs 4.5), armodafinil (6.9 vs 4.8), solriamfetol (6.8 vs 5.4), and pitolisant (6.6 vs 5.2). Twice-nightly SXB and mixed-salt oxybates received high ratings from patients and HCPs for reduction of cataplexy (patients: 7.3 and 7.4; HCPs, 6.7 and 6.8) and EDS (patients: both 7.0; HCPs, both 6.9). Lower satisfaction was reported for twice-nightly SXB and mixed-salt oxybates with dosing frequency (patients, 5.4 and 6.0; HCPs, 5.9 and 6.3) and medication taste (patients, 5.3 and 5.7; HCPs, 5.9 and 6.2).

Conclusion
While both individuals with narcolepsy and HCPs are relatively satisfied with current narcolepsy treatments, both groups are less satisfied with the dosing frequency of currently approved oxybate formulations. ON-SXB will be an additional treatment option that can address this unmet need.

Support (If Any)
Avadel Pharmaceuticals
0409 Self-perceived sleep during the Maintenance of Wakefulness Test: how does it predict accidental risk in patients with sleep disorders?
Authors: Philip Pierre , Micoulaud-Franchi Jean-Arthur , Bioulac Stéphanie , Taillard Jacques , Guichard Kelly , Dauvilliers Yves , Bastien Célyne , Sagaspe Patricia 
Published: May 2022

Abstract

Introduction
The objective of this study is to determine whether the feeling of having slept or not during the Maintenance of Wakefulness Test (MWT) is associated with the occurrence of self-reported sleep-related traffic near misses and accidents in patients with sleep disorders.

Methods
This study was conducted in patients hospitalized in a French sleep center to perform a 4 × 40 min MWT. Relationship between mean sleep latency on the MWT, feeling of having slept or not during MWT trials and sleep-related near misses and accidents reported during the past year was analyzed.

Results
One hundred and ninety-two patients suffering from OSAS, idiopathic hypersomnia, narcolepsy, restless leg syndrome or insufficient sleep syndrome were included. One hundred and sixty-five patients presented no or one misjudgment of feeling of having slept during MWT trials while 27 presented more than two misjudgments. Almost half of the latter (48.1%) reported a sleepiness-related traffic near miss or accident in the past year versus only one third (27.9%) for the former (p &lt; 0.05). Multivariate logistic regression showed that patients with more than two misjudgments had a 2.52-fold (95% CI, 1.07–5.95, p &lt; 0.05) increase in the risk of reporting a sleepiness-related near miss/accident.

Conclusion
Misjudgment in self-perceived sleep during the MWT is associated with the occurrence of self-reported sleepiness-related traffic near misses and accidents in the past year in patients suffering from sleep disorders. Asking about the perception of the occurrence of sleep during the MWT could be used to improve driving risk assessment in addition to sleep latencies.

Support (If Any)
This was not an industry supported study. This project was supported by a grant from the French Sleep Society (SFRMS).
0421 The pupillary light reflex detects hyperarousal and discriminates between adults with nil versus modest insomnia symptoms
Authors: McCall William 
Published: May 2022

Abstract

Introduction
Physiologic and psychologic hyperarousal is a leading candidate mechanism behind insomnia symptoms. Increased levels of physiologic arousal have been demonstrated in insomnia patients versus healthy sleepers using a variety of methods including brain PET, Multiple Sleep Latency Testing, ambulatory core body temperature, and sympathetic nerve microneurography. All of these methods, however, are expensive, or technologically intensive, or invasive. In contrast, the pupillary light reflex (PLR) is comparatively inexpensive, portable, easy to measure, and well-tolerated by patients. The average constriction velocity (ACV) in response to a controlled light stimulus is an indicator of physiologic arousal, with more rapid constriction indicating greater arousal.

Methods
Forty community volunteers provided informed written consent to measurement of their PLR after a period of dark adaptation with the NeurOptics PLRTM-3000 Pupillometer (Laguna Hills, CA), which continuously measures pupil size to a precision of 0.1 mm, at a frequency of 30 Hz. None of the participants were seeking or receiving mental health services, were taking psychotropics, or were using any prescribed or over the counter medication that might affect the PLR. Participants also completed the Patient Health Questionnaire-9 (PHQ-9) and the Insomnia Severity Index (ISI). The protocol was approved by the local IRB.

Results
Sixteen of the volunteers had an ISI score &gt; 4 (“modest ISI”), and 24 had an ISI score &lt; 4 (nil ISI). The overall sample was 26.4 + 9.1 years old, 62.5% female, and 30% non-white, with no significant differences between the ISI score groups. The “nil ISI” and “modest ISI” groups had ISI scores of 1.2 + 1.3 versus 8.7 + 3.6 (p&lt;0.001), PHQ-9 scores of 1.5 + 1.3 versus 5.4 + 4.4 (p&lt;0.005), and ACV of -2.7 + 0.6 versus -3.1 + 0.5 mm/sec (p&lt;0.05), respectively.

Conclusion
This small study of community volunteers showed PLR evidence of relative hyperarousal in those participants with modest levels of insomnia symptoms. With further development, the PLR may have promise in practical identification of a “hyperarousal subtype” of insomnia patients.

Support (If Any)
None
0422 Insufficient sleep in undergraduate students: an intervention based on a systematic literature review
Authors: Pavoni Mariana , Lopes Maria-Cecilia , Cysneiros Laura , Gutierres Gabriela , Silva Elizabeth Araujo e , Braga Victor , Salmazo Henrique 
Published: May 2022

Abstract

Introduction
Sleep is essencial to health, and to the performance of daily activities, and mood, memory, attention, and cognitive processes.

Methods
We systematically reviewed the literature about the sleep in undergratuate students from 2019 to 2020, also we applied a semi-structured questionnaire in 300 undergrate students between 18-24 years of age. Sixteen studies met inclusion criteria in databases: MEDLINE/PUBMED, SCIELO and LILACS on circadian cycle disorders and daytime sleepiness in undergraduate students. The descritptors were applied in order to delimit the articles in the objectives of this study: sleep, undergrade students, daytime sleepiness and circadian cycle disorders. We applyed on-probabilistic sampling technique using Health Educional Content Validation instrument that was composed by 15 items to analyse sleep habbits in undergratuate students.

Results
7591 scientific articles were analyzed, and only 38 were submitted to the application of the PICOS strategy. We included 16 articles in this systematic literate review sample. The studies have shown that the quality of sleep in these students was straongly impaired by stress, depression, family income and behavioral variables. The answers from the Goggle forms analyses with 76.3% of excessive daytime sleepiness, in the area of the questionnaire used a scale from 1 to 5 (where 1 was very little in order to score peculiarities related to the students habits in relation to a routine that values Sleep Hygiene. Fixed times for waking up on weekdays (96, 6%), and only 24.4% of the sample had a fixed time to sleep on weekends. More than 150 students (53.2%) made no effort to stay away from the screen before sleeping. The distribution of responses showed that an average number of people try to avoid using the bed to work or watch television (73.9%) and try to avoid heavy foods before bed (83.1%). We found that the consequences of insufficient sleep, such as insomnia and daytime sleepiness were prevalente in females, and among students who didn’t practice sleep hygiene, were colays and falling asleep during class, twice the risk of depression and headache.

Conclusion
The prevalence of sleep disorders among undergraduated students needs to be evalute, preventing the harmful consequences in their cognitive decisions.

Support (If Any)
0423 Associations of individual behaviors and ambient factors in the sleep environment with nighttime sleep parameters in pregnant women with insomnia
Authors: Badon Sylvia , Manber Rachel , Simpson Norah 
Published: May 2022

Abstract

Introduction
Sleep hygiene and environment are important for adequate sleep quantity and quality. We examined two aspects of the sleep environment, individual behaviors and ambient factors, with nighttime sleep parameters in pregnant women with insomnia.

Methods
We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy for this cross-sectional analysis (n=70). Women completed a questionnaire assessing whether they regularly engaged in five individual behaviors in bed (yes/no) and how much their sleep was disrupted by seven ambient factors (scale from 1=not very much to 5=very much) and wore an Actiwatch 2 for a subsequent 7-day period. Responses of 4 or 5 for ambient factor items were categorized as ambient factors perceived to disrupt sleep. Generalized estimating equation regression models were used to estimate associations of individuals behaviors and ambient factors perceived to disrupt sleep with actigraphy-measured total nighttime sleep duration and sleep efficiency.

Results
The most commonly endorsed individual behaviors were using the internet/computer in bed (64%) and watching television in bed (43%), followed by talking on the phone in bed, listening to music in bed, and playing video/electronic games in bed (16-27%). Watching television in bed was associated with 23 fewer minutes of actigraphy-measured nighttime sleep (95% CI: -44, -1). No individual behavior was associated with actigraphy-measured sleep efficiency (all P&gt;0.05). The most commonly endorsed ambient factors perceived to disrupt sleep were environmental noise (41%) and uncomfortable temperature (37%), followed by movement from others sharing the bed, having to take care of children in the middle of the night, someone else snoring, and light (24-29%). No ambient factors perceived to disrupt sleep were associated with actigraphy-measured nighttime sleep duration or efficiency (all P &gt;0.05).

Conclusion
Individual behaviors and ambient factors perceived to disrupt sleep were common in pregnant women with insomnia. In this study, only watching television in bed was associated with objectively-measured nighttime sleep duration. Our findings suggest that future research could investigate potential interfering roles of arousal and cognitive factors contributing to insomnia during pregnancy.

Support (If Any)
National Institutes of Health (K99HD100585, R01NR013662)
0424 Influence of daytime napping on the discrepancy between subjective and objective nighttime sleep measures in pregnant women with insomnia
Authors: Badon Sylvia , Dietch Jessica , Gumport Nicole , Simpson Norah , Manber Rachel 
Published: May 2022

Abstract

Introduction
Previous research has documented a tendency among adults with insomnia to underestimate nighttime sleep duration compared to actigraphy estimates. We examined whether discrepancy in nighttime sleep parameters is impacted by daytime napping behavior.

Methods
We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy for this cross-sectional analysis (n=97). Women self-reported daytime napping and nighttime sleep characteristics using a 7-day sleep diary and wore an Actiwatch 2 during the same 7-day period. Two women napped daily and were excluded from this analysis. The remaining sample was categorized as intermittent nappers [naps on some but not all days; n=62 (65%)] or non-nappers [no naps on any days; n=33 (35%)]. We summarized daily discrepancy between self-reported and actigraphy-measured nighttime sleep duration and efficiency by daytime napping behavior using means and t-tests.

Results
Intermittent nappers provided data for 130 days with naps and 260 days without naps. Non-nappers provided data for 198 days. Among intermittent nappers, there was no meaningful subjective-objective discrepancy for nighttime sleep duration or efficiency (mean discrepancy=1 minute for duration; -0.4% for efficiency); this did not differ between days with naps and days without naps (p=0.98 for sleep duration; p=0.33 for sleep efficiency). Among non-nappers, subjective-objective discrepancy was present (intermittent nappers vs non-nappers p=0.001 for duration; p=0.04 for efficiency), with self-report underestimating actigraphy-measured nighttime sleep duration by 28 minutes and nighttime sleep efficiency by 3.5%.

Conclusion
Pregnant women with insomnia who did not nap tended to underestimate nighttime sleep duration and efficiency compared to actigraphy measurement, as has been reported in the general population of adults with insomnia. However, there was no meaningful subjective-objective discrepancy for nighttime sleep duration and efficiency among those who napped intermittently, regardless of that day’s napping behavior. It is possible that daytime napping impacts overall accuracy of perceived nighttime sleep. However, because some people with insomnia are unable to nap even when given the opportunity, it is possible that not napping and sleep discrepancy share a common underlying cause. Future research is needed to test if results replicate to non-pregnant populations and explore mechanisms that may explain these findings.

Support (If Any)
National Institutes of Health (K99HD100585, R01NR013662)
0426 Shallower sleep depth in the laboratory is not related to insomnia severity
Authors: Larson Olivia , Younes Magdy , Weljie Aalim , Sengupta Arjun , Gehrman Philip 
Published: May 2022

Abstract

Introduction
In insomnia, classical sleep scoring parameters are often uncorrelated with symptom severity and may not fully capture more subtle alterations in the polysomnogram (PSG) that could contribute to clinical symptoms. The odds ratio product (ORP) is a well-validated, continuous index of sleep depth (range 0=deep sleep; 2.5=full wakefulness) that offers an alternative to traditional staging. It is unknown whether ORP is related to self-reported insomnia severity. We hypothesized that individuals with insomnia would exhibit higher ORP values than healthy controls (reflecting less deep sleep) which would be associated with greater insomnia severity.

Methods
This is a secondary analysis of data from a study in which n=15 participants with chronic insomnia disorder and n=15 age- and sex-matched healthy controls completed an in-laboratory protocol (N=30; 66% female; 36±8 years; 63% White). Participants had their sleep monitored with in-lab PSG. The Insomnia Severity Index (ISI) was used to estimate sleep disturbance severity. PSG were used to calculate classical sleep scoring parameters as well as the average ORP in each sleep stage. Independent samples t-tests compared means between the insomnia and healthy control groups and Pearson’s correlations assessed relations between PSG/ORP outcome measures and ISI scores.

Results
The insomnia group’s mean (SD) ISI score was 14.13 (6.00) and significantly higher than the control group’s (1.73 (2.37); corrected p &lt; 0.001). There were no statistically significant between-group differences for classically-scored sleep parameters or average ORP values after correcting for multiple comparisons. Interestingly, means for the insomnia group’s average ORP values tended to be higher than those of the control group’s. ISI scores were not significantly associated with average ORP values across or within groups.

Conclusion
Insomnia does not appear to be associated with alterations in global sleep depth when measured in a laboratory setting, but there is a need to conduct more detailed analyses on patterns across the night.

Support (If Any)
Merck, Inc. Investigator Studies Program
0430 Beyond symptoms: Using the Cost of Insomnia Checklist to Characterize the Subjective Burden of Insomnia
Authors: Glidewell Robert , Gallegos Taela , Okun Michele 
Published: May 2022

Abstract

Introduction
Traditional symptom focused assessments do not characterize the subjective impact of insomnia on patient's function and quality of life (QOL). The authors developed the Cost of Insomnia Checklist (CIC) to evaluate the effects of insomnia in the life domains most meaningful to patients. In bringing attention and awareness to these areas, such a tool may increase patient motivation to look for, initiate, and or persist in treatment. It may also help overcome habituation effects that lead patients to minimize the seriousness of insomnia.

Methods
The CIC has 68 items across seven categories (financial; health; family; cognition; mental and emotional; work; social and recreational). We developed CIC items based on clinical interviews with chronic insomnia patients in a behavioral sleep medicine clinic. Ninety-five patients completed the CIC during their clinical evaluation for chronic insomnia.

Results
Participants were 53% female, 81% white, 57% employed, 56% married, and 23% living alone with a mean age of 50.48 (+/- 16.03) and mean BMI of 24.91 (+/-5.29). Patients endorsed an average of 21.9 (SD 33.9; Median=21) items with a range of 4 to 52 items. The most often endorsed items (&gt;70%) focused on not feeling rested, worry about sleep, daytime sleepiness and fatigue, and memory and attention problems. 97% of respondents endorsed one or more additional items. The most frequently endorsed additional items were “can't maintain energy level” (69.5%), “too tired to exercise” (57.9%), “discomfort of sleeplessness” (56.8%), “irritable/unkind to others” (55.8%), “can't think of the words I want to use” (54.7%), “unmotivated/uninterested” (54.7%), “daytime discomfort after a bad night” (53.7%), “stressed without good reason” (52.6%), “worry about daytime function” (51.6%), “news/doctors tell me Insomnia is bad for me” (50.5%).

Conclusion
The CIC evaluates the effect of insomnia in many life domains and may help patients recognize the impact of insomnia on daytime function and QOL. Future studies will measure how the CIC correlates with treatment participation, adherence, and outcomes. Future studies will also support revision of the CIC to keep only items not measured by other instruments.

Support (If Any)
None
0451 Effect of Lemborexant Treatment on Polysomnographic Sleep Measures in Older Adults with Insomnia and Objective Short Sleep
Authors: Krystal Andrew , Edinger Jack , Kumar Dinesh , Pappadopulos Elizabeth , Malhotra Manoj , Moline Margaret 
Published: May 2022

Abstract

Introduction
In Phase 3 Study 304 (NCT02783729), lemborexant (LEM) provided significant benefit versus placebo (PBO) on polysomnographic (PSG) and sleep diary-based sleep onset and maintenance outcomes over 1mo in subjects with insomnia disorder. Based on evidence that patients with insomnia and objective short sleep (ISS [total sleep time; TST] &lt;6hrs) may respond less well to interventions such as cognitive behavioral therapy for insomnia (CBT-I) than patients with insomnia and objective long sleep (TST ≥6hrs), we conducted post-hoc analyses of LEM efficacy in the ISS subgroup (subjects with PSG TST&lt;6hrs).

Methods
Study 304 was a 1mo, randomized, double-blind, PBO- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006). Subjects received PBO, LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate extended-release 6.25mg (ZOL). Latency to persistent sleep (LPS) and wake after sleep onset (WASO) were assessed at Nights (NT) 1/2 and NT29/30 using PSG and averaged; change from baseline (paired PSGs during single-blind PBO run-in) were analyzed using mixed-effect model repeated measurement analysis.

Results
The ISS subgroup comprised 710/1006 (70.58%) subjects. Mean (SD) baseline LPS was similar across treatments: PBO=52.80(35.73); ZOL=54.77(40.93); LEM5=54.28(39.30); LEM10=53.31(34.45). On NT1/2, LEM5/10 led to statistically significantly greater (P&lt;0.05) decreases from baseline (PBO=−9.65[36.52]; ZOL=−17.78[36.34]; LEM5=−22.02[31.62]; LEM10=−25.42[34.73]) versus PBO and ZOL. On NT29/30, LEM5/10 led to statistically significantly greater (P&lt;0.0005) decreases from baseline (PBO=−11.88[35.09]; ZOL=−12.57[38.50]; LEM5=−25.37[37.06]; LEM10=−28.20[34.75] versus PBO. ZOL was not different from PBO. Mean (SD) baseline WASO was similar: PBO=123.79(37.21); ZOL=128.37(38.94); LEM5=128.14(37.52); LEM10=129.07(37.98). On NT1/2, LEM5/10 led to statistically significantly greater (P&lt;0.0001) decreases from baseline (LSM[SE]: PBO=−23.52[2.74]; ZOL=−54.74[2.47]; LEM5=−60.58[2.45]; LEM10=−69.35[2.41] versus PBO. LEM10 was significantly different than ZOL (P&lt;0.0001). On NT29/30, LEM5/10 led to statistically significantly greater (P&lt;0.0001) decreases from baseline (PBO=−29.62[3.09]; ZOL=−46.86[2.80]; LEM5=−52.67[2.74]; LEM10=−55.37[2.70] versus PBO. LEM10 was significantly different than ZOL (P&lt;0.05).

Conclusion
The data support LEM as an effective therapy for older adult patients with ISS and suggest LEM may be more beneficial than ZOL, particularly for patients with ISS and sleep onset difficulties. These findings suggest that LEM may be a reasonable therapy to consider for treating older patients with ISS where CBT-I may have relatively limited efficacy.

Support (If Any)
Eisai Inc.