bluuebunny/crossref_metadata_2025_split huggingface dataset:
0591 Effectiveness and Optimization of Lower-Sodium Oxybate in Participants With Narcolepsy Switching From Sodium Oxybate (SEGUE)
Authors: Leary Eileen , Pfister Craig , Fuller Douglas , Macfadden Wayne 
Published: May 2023

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 &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.
0595 Long-term efficacy on cataplexy attacks and excessive daytime sleepiness in open-label extension study (NLS-1022) of mazindol ER
Authors: Stern Thomas , Corser Bruce , Bogan Richard , Franco Jennifer , Konofal Eric , Apostol George , Rosenberg Russell , Morse Anne , Thorpy Michael , Kushida Clete 
Published: May 2023

Abstract

Introduction
Mazindol ER (extended-release), the first partial orexin-2 receptor agonist and triple mono-aminergic reuptake inhibitor, has demonstrated efficacy and safety in significantly reducing excessive daytime sleepiness (EDS) and cataplexy attacks in narcolepsy type 1 (NT1) and type 2 (NT2) patients (POLARIS, Study NLS-1021). This efficacy was further studied in an open-labeled extension (OLE) study (ClinicalTrials.gov Identifier: NCT04923594).

Methods
A multicenter, 6-month, OLE study with 51 narcolepsy patients previously enrolled in a double-blind mazindol ER study. Patients were administered 3mg mazindol ER once daily in the morning. Narcolepsy symptoms and adverse events were recorded. Safety measures included monthly physical and laboratory examinations. The primary efficacy measure was the change from baseline in EDS using the Epworth Sleepiness Scale (ESS). Secondary measures included weekly cataplexy attacks, the overall disease severity as rated by the investigators (Clinician Global Impression of Severity) and patients (Patient Global Impression of Severity).

Results
Mazindol ER at 3 mg once-daily doses, produced overall improvements in EDS and narcolepsy within 1-2 weeks of starting dosing. Reported improvements included diminished daytime sleepiness (p &lt; 0.001); significant decreases in cataplexy attacks (p &lt; 0.001); and multiple improvements in symptoms severity and function. Adverse events were generally mild and patients showed no evidence of tolerance.

Conclusion
Mazindol ER is a convenient, safe, well-tolerated and effective treatment for narcolepsy. Its anticataleptic and wake-promoting effects indicate that it may be a new therapeutic option for patients with NT1 or NT2 similar or better than various combinations treatments currently available.

Support (if any)
NLS Pharmaceutics
0597 Path to Diagnosis and Impact of Narcolepsy on Quality of Life: A Survey of People Living With Narcolepsy
Authors: Ortiz Luis , Morse Anne , Krahn Lois , Lavender Maggie , Horsnell Matthew , Cronin Dianna , Schneider Beth , Gudeman Jennifer 
Published: May 2023

Abstract

Introduction
Research was undertaken to better understand the path to a narcolepsy diagnosis, common symptoms, and the impact of narcolepsy on work, social interactions, and mental health.

Methods
In February 2022, an email invitation to an online, 27-question survey was sent to US members of MyNarcolepsyTeam, a social network of &gt;9,800 members.

Results
In total, 110 members completed the survey. 38% of respondents started to experience symptoms before reaching 16 years of age. Most commonly experienced symptoms included excessive daytime sleepiness (EDS; 93%) and fatigue (84%). In total, 72% were also experiencing some form of sleep disturbance and 67% were already suffering from cognitive/memory challenges. 68% who were eventually diagnosed with narcolepsy type 1 (NT1) had cataplexy attacks. For 31%, getting to a narcolepsy diagnosis took ≥10 years. In fact, 64% were initially under- or misdiagnosed with something other than narcolepsy, including depression (73%), sleep apnea (36%), or attention-deficit/hyperactivity disorder (16%). 74% of patients with NT1 have continued to experience cataplexy, with 46% having some form of a cataplexy episode a few times per week. Cataplexy episodes were triggered by a wide range of emotional situations, including over-tiredness (70%), anger (48%), being startled (46%), laughter (46%), fear (44%), excitement (38%), or crying (33%). 76% of respondents indicated that the impact of narcolepsy on daily life is extremely or very severe. The far-reaching impact on quality of life was evident in that most respondents reported that narcolepsy interfered with work (82%), social life (86%), everyday chores (85%), and exercise (85%) and has limited career options (76%). The emotional toll of narcolepsy manifested in feeling isolated (83%), depressed (81%), anxious (80%), or embarrassed (75%).

Conclusion
Patients routinely experienced a misdiagnosis or a “missed” diagnosis based on common symptoms experienced. Being able to quickly identify narcolepsy as the root cause for symptoms of EDS, fatigue, and sleep disturbances can lead to getting the patient on the best treatment path as early as possible. Understanding the physical, emotional, and quality-of-life impact of narcolepsy can help clinicians provide a more holistic approach to treating their patients.

Support (if any)
Avadel Pharmaceuticals
0598 Patient-Reported Sleep Quality in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate
Authors: Husain Aatif , Zee Phyllis , Leary Eileen , Macfadden Wayne , Fuller Douglas , Candler Shawn , Bae Charles 
Published: May 2023

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
0606 Fatigue or excessive daytime sleepiness, which is more related with depression?
Authors: Yang Kwang Ik , Yim Soo Hwan , Lee Seung Cheol , Kim Daeyoung , Chu Min Kyung , Yun Chang-Ho 
Published: May 2023

Abstract

Introduction
Fatigue and excessive daytime sleepiness (EDS) were often regarded as having almost similar meaning in routine daily life. However, these two terms are strictly distinct concepts. The effect on depression between EDS and fatigue, which coexist depending on the situation or exist individually. We aimed to investigate both fatigue and EDS were classified in detail to determine which is more related to depression in the general population.

Methods
A total of 2,493 participants (female: 1,257) (47.90 ± 0.33 years old) were investigated nationwide, across 15 South Korean districts using face-to-face interviews survey. Fatigue, EDS, and depression were evaluated using the Fatigue Severity Scale (FSS), Epworth sleepiness scale (ESS), and Patient Health Questionnaire-9 (PHQ-9), respectively. The covariates such as sleep habits and socio-behavioral factors were included.

Results
The prevalence of depression (PHQ-9 ≥ 10) was 8.42% (n = 210). Fatigue (FSS ≥ 36) was 30.8% (n = 767). EDS (ESS ≥ 11) was 15.3% (n = 382). The prevalence of depression was following four categories; EDS with fatigue (E+F+) (n = 67, 31.9% vs. 7.3%) (P &lt; 0.001), fatigue without EDS (E-F+) (n = 71, 33.8% vs. 20.3%) (P &lt; 0.001), EDS without fatigue (E+F-) (n= 16, 7.6% vs. 5.8%) (P = 0.294), and absence of fatigue and EDS (E-F-) (n = 56, 26.7% vs. 66.6%) (P &lt; 0.001). After adjusting for covariates, the presence of depression (E-F-, reference) was associated with E+F+ (OR 8.804, 95% CI 5.818-13.321), E-F+ (OR 3.942, 95% CI 2.704-5.747), and E+F- (OR 2.812, 95% CI 1.542-5.131). We additionally performed logistic regression according to two categories. There was no significant difference of prevalence of depression between E+F- (reference) and E-F+ (OR 1.399, 95% CI 0.760-2.575).

Conclusion
Although fatigue and EDS were associated with depression regardless of the presence of each other. But we did not find out which is more related with depression.

Support (if any)
0624 Sleep Duration and Insomnia Predict Increases in Depression in Adolescents at Subsequent 3-Month Intervals: A Longitudinal Study
Authors: Hijazi Joud , Oryschkewych Nina , Hafer Bethany , Kristo Grant , Wallace Meredith , Goldstein Tina , Buysse Daniel , Franzen Peter 
Published: May 2023

Abstract

Introduction
Adolescence is a critical developmental period for mental health, with the incidence of depression increasing significantly during this period. Both short sleep duration and insomnia are common and associated with depression risk. Longitudinal studies examining the relationship between sleep and depression in adolescents are scarce; therefore, the current study investigates the influence of sleep duration and insomnia on future increases in depressive symptoms.

Methods
A community sample of 151 never-depressed healthy adolescents (56.3% female; mean age = 14) were enrolled in 7th-9th grade (ages 11-15 years old) and followed for up to two years. On-line self-report questionnaires were collected every 3 months, including the Center of Epidemiology Studies Depression Scale (CES-D), the Insomnia Severity Index (ISI), and the Sleep Timing Questionnaire (STQ). The sleep item was excluded from the CES-D score used for analysis. Sleep duration was estimated through reported usual time in bed on the STQ (weighted average of weekdays and weekends). Separate mixed effects analyses examined whether time in bed or ISI predicted CES-D scores 3 months later, controlling for gender, age, and lag CES-D.

Results
Depression was associated with both time in bed (t(736)=-2.8, p&lt; 0.005) and Insomnia Severity Index (t(736)=2.3, p=0.02). For every one standard deviation decrease in time in bed, depression was predicted to increase by 0.15 points 3 months later. For every one standard deviation increase in Insomnia Severity Index, depression was predicted to increase by 0.12 points 3 months later.

Conclusion
The findings suggest that lower time in bed and higher insomnia predict increases of depression in the following 3 months. Given that sleep is a modifiable risk factor for depression, improving sleep health may help ameliorate depression during this high-risk period.

Support (if any)
Source of support is the National Institutes of Health (R01 MH118312).
0636 Examination of longitudinal chronotype stability in individuals with bipolar disorder and healthy controls
Authors: Sperry Sarah , Boland Elaine , Burgess Helen , Gonzalez Robert , Gonzalez Suzanne , Lane Jacqueline , McCarthy Michael , Menkes Margo , Murphy Victoria , Gehrman Philip 
Published: May 2023

Abstract

Introduction
Introduction: Circadian rhythms have long been conceptualized as central to the pathophysiology of bipolar disorder (BD). Numerous cross-sectional analyses have demonstrated associations of eveningness with BD and greater severity of mood symptoms. Longitudinal studies that evaluate stability of chronotype and its association with mood symptoms are lacking.

Methods
88 BD2) from the Prechter Longitudinal Study of BD. Participants completed an average of 10 years of longitudinal assessments of depression (PHQ-9) and mania (Altman Self-Reported Mania Scale) every 2 months, and chronotype (Munich ChronoType Questionnaire) annually. Chronotype was assessed using both a single item from the MCTQ in which seven possible chronotypes were presented (from extreme early to extreme late type), and the calculation of midpoint of sleep on work-free days, sleep-corrected (MSFsc). We calculated (in)stability using the mean square successive difference (MSSD) and assessed the relationship between mood, age, sex, medication, and stability using mixed effects models.

Results
Results: Individuals with BD1 and BD2 reported later chronotypes compared to HC. Individuals with BD1 had later MSFsc as well as greater instability in chronotype and MSFsc compared to HC. Greater instability in chronotype was associated with higher depression and mania symptom severity. Treatment with mood stabilizers was associated with less instability in MSFsc, while antidepressant treatment was associated with greater instability in MSFsc.

Conclusion
Discussion: These results provide the strongest evidence to date of later chronotypes in individuals with BD. This is the largest examination of longitudinal stability of chronotype and results indicate that only BD1 is associated with greater instability over time. This instability, in part, reflects changes in mood symptoms over time, as well as in medication use. These data highlight the importance of assessment and treatment of circadian disruption in individuals BD.

Support (if any)
Heinz C. Prechter Bipolar Research Program
0638 Comparison of social jet lag between individuals with seasonal affective disorder and controls
Authors: Hine Kaylee , Wescott Delainey , Klevens Alison , Taylor Maddison , Roecklein Kathryn 
Published: May 2023

Abstract

Introduction
Social jet lag (SJL) occurs when a person’s social time (weekdays) is out of phase with their circadian time (weekend). Not much is known about the relationship between Seasonal Affective Disorder (SAD) and SJL; however, the sleep/wake cycle is very vulnerable to disruption by external factors. In a previous study in adolescents and young adults, self-reported chronotype was used to calculate SJL, and winter mood variation and SJL were found to be higher after the time change in fall and winter. Our study will directly compare SAD and non-depressed controls in the winter on SJL calculated with actigraphy in a sample of adults.

Methods
Participants (N=46) ages 21-64 were recruited during winter months and included individuals with SAD (n=21) and nonseasonal, never depressed controls (n=25). Midsleep timing was measured using actigraphy (average number nights = 7), and SJL was calculated by subtracting average week midsleep from average weekend midsleep corrected for number of days. Regression analysis included diagnostic group as a predictor, age and gender as covariates, and SJL as the outcome.

Results
While the seasonally depressed group had a slightly higher average SJL (M =61.8 minutes, SD = 181.2 minutes) than the control group (M = 60.6 minutes, SD = 165 minutes; mean difference 1.2 minutes), there was no significant difference in SJL between the participants with seasonal depression and the controls (p=0.778). However, age was a significant predictor, as the younger half of the sample had a mean SJL of 94 minutes (SD=180 minutes) and the older half of the sample had a mean SJL of 24 minutes (SD= 156 minutes; mean difference= 70 minutes). There was no group*age interaction in post-hoc tests.

Conclusion
This is the first study to test whether individuals with SAD have greater SJL than non-depressed controls, and the data do not support such a hypothesis. Results do, however, confirm prior findings that SJL decreases with age. Future studies should compare SJL in individuals with SAD during winter compared to spontaneous summer remission to test whether a change in SJL correlates with winter depression onset.

Support (if any)
NIMH K.A.R. MH103303
0645 Prevalence of sleep disorders and their association with posttraumatic stress and anxiety symptoms among college students
Authors: Roeper April , Covington Lauren , Ji Xiaopeng , Brownlow Janeese 
Published: May 2023

Abstract

Introduction
Incidence of diagnosed psychiatric disorders tend to peak during early adulthood. Furthermore, sleep complaints are highly prevalent among college students, and often exacerbate psychiatric disorders. This study aimed to explore the prevalence of sleep disorders, and their association with posttraumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) symptoms among college students.

Methods
College students completed self-report measures as part of a larger study (n=56; mean age 20.23 (SD=1.5); 83.9% females). The SLEEP-50 questionnaire estimated the prevalence of sleep disorders. Each sleep disorder required a cutoff score and at least one sleep complaint, with a minimum score of three or four used to classify a sleep complaint. The GAD-7 scale assessed for generalized anxiety disorder symptoms, and the PCL-5 determined PTSD symptomatology. Linear regression models identified the association between each sleep disorder on posttraumatic stress and generalized anxiety symptoms.

Results
Approximately 19.6% of students were at risk for at least one sleep disorder. The most frequent sleep disorder was hypersomnia (69.5%), followed by narcolepsy (53.6%), insomnia (48.2%), affective disorder (28.6%), and restless leg syndrome (21.4%). In contrast, circadian rhythm disorder (16.1%) and sleep apnea (7.1%) were infrequently reported. Linear regression models indicated that affective disorder (t=2.83, p&lt;.007; t=3.13, p&lt;.003) and hypersomnia disorder (t=2.31, p=.025; t=2.39, p=.020) significantly predicted PTSD and GAD symptoms respectively. Additionally, insomnia (t=3.97, p&lt;.001) and restless leg syndrome (t=2.34, p=.023) were significant predictors for GAD only, and circadian rhythm disorder (t=2.760, p=.008) was a significant predictor for PTSD only.

Conclusion
Results suggest that risk of sleep disorders was significantly associated with PTSD and GAD symptoms in college students. Given these findings, health promotion programs are needed to promote good sleep hygiene and early interventions for mental health during college years.

Support (if any)
This study was funded by a Center Grant from the National Institutes of General Medical Sciences (Grant # P20GM103653).
0653 The effects of light exposure on retinal responsivity in seasonal affective disorder
Authors: Taylor Maddison , Wescott Delainey , Klevens Alison , Roecklein Kathryn 
Published: May 2023

Abstract

Introduction
Seasonal affective disorder (SAD) is characterized as patterned depressed mood that emerges during the fall/winter and enters remission during the spring/summer. Retinal responsivity is lower in SAD in the winter and may contribute to the seasonal pattern of mood disruption (Roecklein et al., 2021). Light exposure in the month prior has been shown to influence retinal responsivity (Kawasaki et al., 2018). No work to date has investigated how more proximal prior light history may influence retinal responsivity differently in individuals with SAD versus controls. This study sought to examine group differences in how environmental blue light exposure impacts retinal responsivity in the 2 hours prior.

Methods
Participants included 19 never depressed controls (Mean Age = 33, SD = 11), and 17 individuals diagnosed with SAD (Mean Age = 36, SD = 10). SAD episode criteria were assessed using the SCID-5 and SIGH-SAD. Retinal responsivity was measured using the Post-Illumination Pupil Response (PIPR) in the winter months. The PIPR was calculated as percent of baseline difference between the blue and red stimuli from 10-30 secs. Light exposure was measured using the Phillips Actiwatch blue light levels in photon flux in 30-second epochs for 2 hours before the PIPR. Means were calculated and cube transformed to account for right skew. Covariates included circadian time of PIPR testing, calculated from DLMO, and Pupil Light Reflex as a measure of retinal irradiance.

Results
Multiple regressions were performed for the SAD and control groups, separately. Results indicated that the mean blue-light exposure 2-hours before the PIPR did not significantly predict PIPR in either group (Control group: b = -13e-7, p = 0.31/ SAD group: b = -12e-7, p = 0.13).

Conclusion
This is the first study to find that light exposure within the prior 2 hours does not influence retinal responsivity in SAD or control participants. Future studies should evaluate different light exposure parameters, such as a longer duration of light exposure before the PIPR, variation in light exposure across different timeframes, and circadian time of light exposure.

Support (if any)