bluuebunny/crossref_metadata_2025_split huggingface dataset:
0395 Effectiveness and Treatment Optimization Among Participants With Narcolepsy Switching From Sodium Oxybate to Lower-Sodium Oxybate: Interim Data From the SEGUE Study
Authors: Leary Eileen , Kirby Todd , Skowronski Roman , Xu Kevin , Pfister Craig , Macfadden Wayne 
Published: May 2022

Abstract

Introduction
Lower-sodium oxybate (LXB) contains 92% less sodium than sodium oxybate (SXB) and is approved for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy (≥7 years of age) and for treating idiopathic hypersomnia in adults. The SEGUE study examines safety, tolerability, effectiveness, and treatment optimization in participants with narcolepsy transitioning from SXB to LXB.

Methods
Eligible participants in this ongoing, multicenter, open-label study are adults with narcolepsy type 1 or 2 who are 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 switch to the same dose/regimen of LXB (intervention period; 6 weeks). If needed, LXB dose/regimen is titrated to optimize efficacy/tolerability. Assessments include the Patient Global Impression of Change (PGIc), a forced preference questionnaire (FPQ), and an ease of switching medication scale (EOSMS; all collected at end of treatment/early discontinuation). An interim analysis (first 24 participants to complete the study) is reported.

Results
A majority of participants were female (54%) and White (92%); mean (SD) age was 45.5 (16.20) years. Starting and ending (end of treatment/early discontinuation) median total nightly doses of LXB were both 9.0 g. Most participants took LXB twice nightly (88% at both time points). Twenty-two participants completed the transition period; mean (SD) time to optimized dose was 1.4 (1.56) days, and median (range) number of changes in dose/regimen was 0.0 (0, 1). At end of treatment/early discontinuation, most participants reported improvement (very much/much/minimal; 57%) or no change (43%) in narcolepsy symptoms on the PGIc, preferred LXB over SXB on the FPQ (86%), and reported that the transition to LXB was easy (easy/extremely easy/not difficult at all) on the EOSMS (91%).

Conclusion
Participants with narcolepsy switched from SXB to LXB with minimal modifications of dose/regimen and reported that the transition process was easy. Efficacy of oxybate treatment was maintained or improved, and most participants preferred LXB over SXB.

Support (If Any)
Jazz Pharmaceuticals.
0398 Is Increased Serum Prolactin Associated with Excessive Daytime Sleepiness? A Proof-of-Concept Analysis
Authors: Mogavero Maria , Cosentino Filomena , Lanuzza Bartolo , Tripodi Mariangela , Lanza Giuseppe , Aricò Debora , DelRosso Lourdes , Pizza Fabio , Plazzi Giuseppe , Ferri Raffaele 
Published: May 2022

Abstract

Introduction
With this study we aimed to: 1) identify subjects with hyperprolactinemia in a clinical sample of patients; 2) compare the neurologic, psychiatric, and sleep conditions found in patients subgrouped by excessive daytime sleepiness (EDS) and hyperprolactinemia; 3) identify patients with hyperprolactinemia and EDS not supported by the presence of any other neurologic, psychiatric, or sleep disorder, or substance/medication use.

Methods
A retrospective chart review of inpatients was carried out in order to identify all patients in whom the prolactin (PRL) serum levels were determined. A total of 130 subjects were retrieved: 55 had increased levels of PRL while the remaining 75 participants had normal PRL levels.

Results
EDS was reported by 32 (58.2%) participants with increased PRL and 34 (45.3%) with normal PRL. Obstructive sleep apnea or other sleep or neurologic/psychiatric conditions could explain EDS in all participants with normal PRL. Among subjects with increased PRL, eight had no other neurologic/psychiatric or sleep disorder (or drug) potentially causing EDS; these participants, at polysomnography, had time in bed, sleep period time, and total sleep time longer than those with EDS associated to another condition.

Conclusion
These findings can be considered as a preliminary indication of a role of hyperprolactinemia in EDS and represent a basis for future controlled studies able to test in a reliable, objective, and methodologically more appropriate way this hypothesis.

Support (If Any)
This study was partially supported by a fund from the Italian Ministry of Health “Ricerca Corrente” (RC n. 2764026) (Drs. Cosentino, Aricò, Lanuzza, Lanza, Tripodi, and Ferri)
0400 Sleep Onset REM Period (SOREMP); Beyond the Diagnostic Marker
Authors: Honda Makoto , Ito Wakako 
Published: May 2022

Abstract

Introduction
Shortened mean sleep latency and multiple Sleep Onset REM Period (SOREMP) on MSLT has been used as a characteristic marker for narcolepsy and incorporated in all editions of International Classification of Sleep Disorders. Epidemiologic studies have shown that SOREMP could occur in general population especially those with sleep insufficiency and shift work. However the physiological meaning of SOREMP besides the diagnostic marker is not well clarified. We searched for subjective and objective sleep variables independently associated with the number of SOREMPs.

Methods
Participants were 769 consecutive sleepy patients or controls who gave written informed consent and underwent PSG followed by MSLT in Seiwa Hosiptal or Koishikawa Tokyo Hospital from October 2014 to November 2021. We excluded those with obvious nocturnal sleep disturbances (AHI≥10, PLMI≥15), with medication affecting sleep and with severe first-night effect at the time of PSG. We analyzed data from resultant 580 participants (male/female=312/268, age 25.3±8.4 years old, BMI 21.6±3.3). They were subdivided into 4 groups according to the number of SOREMPs on MSLT (used as ordinal scale). Subjects with 3 or more SOREMPs were merged into one group to increase number enough for statistical analyses. We dichotomized participants into narcolepsy type 1 (NT1) (n=50) and others (n=530) to adjust the effect of NT1 diagnosis. Epworth Sleepiness Scale (ESS) as well as conventional sleep variables on PSG and MSLT were compared by ANOVA and variables associated with the number of SOREMPs were further analyzed by regression analyses to determine the independent association after adjustment of covariates (age, sex, BMI and dichotomized diagnosis).

Results
Number of SOREMPs on MSLT was positively associated with ESS score (p=0.010), Total Sleep Time (TST) (p=0.03), REM %TST(p&lt;0.001), and negatively associated with Sleep Latency (p&lt;0.01), REM Latency (p&lt;0.001), MSLT mean Sleep Latency (p&lt;0.001) and MSLT REM Latency (p&lt;0.001) and subjective sleep latency on PSG night.

Conclusion
Our data indicate that the number of SOREMPs have physiological significance besides narcolepsy diagnosis. More SOREMPs reflects higher sleep propensity and REM propensity as well as subjective sleepiness. The number of SOREMPs can be a marker reflecting one aspect of sleepiness. Our study will also contribute to better understand the meaning of SOREMP in diagnostic criteria of central disorders of hypersomnolence.

Support (If Any)
This study was partly supported by JSPS KAKENHI Grant Number JP21H02856.
0402 Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, in Patients With Narcolepsy: Post-hoc Sensitivity Analyses From the REST-ON Trial
Authors: Kushida Clete , Roth Thomas , Thorpy Michael , Seiden David , Dubow Jordan , Gudeman Jennifer 
Published: May 2022

Abstract

Introduction
In REST-ON, once-nightly sodium oxybate (ON-SXB; FT218) achieved significant improvement (P&lt;0.001) vs placebo for all coprimary endpoints: Maintenance of Wakefulness test (MWT) mean sleep latency, Clinical Global Impression of Improvement (CGI-I) rating, and weekly number of cataplexy attacks (NCA).

Methods
Individuals aged ≥16 years were randomized 1:1 to receive ON-SXB (1 week, 4.5 g; 2 weeks, 6 g; 5 weeks, 7.5 g; 5 weeks, 9 g) or placebo. Post-hoc sensitivity analyses were conducted with methods to handle missing data: completer population; placebo-based multiple imputation (MI) with missing not at random assumption; analysis of covariance (ANCOVA); and tipping point-based MI of worsening values until P&gt;0.05.

Results
Completers (ON-SXB, n=69; placebo, n=79) showed significant improvement (P&lt;0.001) with 6, 7.5, and 9 g ON-SXB vs placebo on all coprimary endpoints; with 9-g dose, mean (95% CI) differences vs placebo were 6.0 min (3.3–8.7) on MWT and –6.6 (–9.6 to –3.6) in NCA; 72.3% and 31.6%, respectively (odds ratio [OR], 5.7 [95% CI: 2.8–11.6]), were CGI-I responders. All ON-SXB doses achieved significant improvement (P&lt;0.001) vs placebo on all coprimary endpoints with placebo-based MI and ANCOVA. With placebo-based MI, mean (95% CI) differences vs placebo (9-g dose) were 5.4 min (2.8–8.0) on MWT and –6.4 (–11.3 to –3.7) in NCA; 63.0% and 28.5%, respectively (OR, 4.3 [95% CI: 2.3–8.0]), were CGI-I responders. With ANCOVA, mean (95% CI) differences vs placebo (9-g dose) were 6.0 min (3.6–8.5) on MWT and –6.4 (–9.0 to –3.8) in NCA; CGI-I rating difference was –1.0 (–1.3 to –0.7). With MWT tipping point MI, between-treatment differences lost significance with worsening of 7.0, 5.2, and 4.3 min from baseline for 6, 7.5, and 9 g, respectively (implausible for 7.5- and 9-g doses). When withdrawals from ON-SXB were imputed as “not improved,” CGI-I remained significant (all 3 doses, P&lt;0.001). Mean NCA remained significant for all 3 doses vs placebo with worsening trajectories imputed; positive results were not tipped over with plausible values.

Conclusion
These results support the robustness of the primary efficacy data for ON-SXB for narcolepsy treatment.

Support (If Any)
Avadel Pharmaceuticals
0418 Use of Actigraphy for the Optimization of the Diagnosis and Treatment of Hypersomnia
Authors: Chen Brian , Wang Lu , Mehra Reena , Shah Vaishal 
Published: May 2022

Abstract

Introduction
Actigraphy and sleep logs are used prior to Mean Sleep Latency Test (MSLT) testing to effectively interpret MSLT. Inaccuracies in sleep logs may inadvertently mask insufficient sleep, thereby resulting in a false positive MSLT. We evaluate the use of actigraphy in comparison to patient-reported sleep logs in the diagnosis and treatment of hypersomnia.

Methods
Retrospective analysis of n=56 patients (average age 39±16.8 years, 19.5% male) who underwent evaluation for hypersomnia with actigraphy, sleep diary, polysomnogram (PSG), and MSLT in 2021 at the Cleveland Clinic was completed. Data was collected from the electronic medical record, actigraphy and polysomnography softwares. Positive MSLT (MSL) was defined as ≤8min. Average total sleep time (TST) from actigraphy and sleep logs were divided into three different time points; inadequate TSTs were defined at ≤8hours and ≤7hours, and invalid TST at ≤6hours. Paired t-test was used to compare TST from actigraphy and sleep diary. Receiver operating characteristic (ROC) analysis was performed to investigate the discrimination of MSLT(≤8min) by total sleep time from actigraphy and sleep logs using area under curve (AUC).

Results
Mean TST did not have a statistically significant difference between actigraphy and sleep logs (7.8±1.3 hours vs. 8.0±1.5 hours, p=0.53). However, on sub-analysis, out of 20 people who reported &gt;8hours average TST on sleep logs, 11 were objectively found to have ≤8hours of average TST on actigraphy (55%). Of the 34 who reported &gt;7hours TST on sleep logs, 8 had ≤7hours on actigraphy (24%). Of the 41 who reported &gt;6hours TST on sleep logs, 1 had ≤6hours on actigraphy (2%). On MSLT, the average MSL was 12.7±5.1min, with 20% of patients with times ≤8min. Actigraphy performs better than sleep logs in discriminating MSL ≤8min (AUC 0.67 vs. 0.61).

Conclusion
Actigraphy is more objective than sleep logs and thus less prone to human recall errors. This study demonstrates the utility of actigraphy in the validation of the MSLT and in the accurate diagnosis of disorders of hypersomnia. In the future, our continued collection of an actigraphy and sleep log database will allow for more detailed analyses including consideration of the influence of medications on these findings.

Support (If Any)
0425 New onset insomnia following COVID-19 infection
Authors: Viereck Matthew , Javaheri Sogol 
Published: May 2022

Abstract

Introduction
Post-COVID neuropsychiatric symptoms have a significant impact on morbidity following COVID-19 infection. We present three patients without a prior history of insomnia symptoms who developed new-onset and chronic insomnia following infection with COVID-19.

Methods
Retrospective chart review was performed on three patients who presented to an ambulatory sleep clinic with complaints of new onset insomnia following COVID-19 infection.

Results
Three patients without a history of prior insomnia developed difficulty initiating or maintaining sleep during or following COVID-19 infection. Patient 1 developed symptoms of insomnia 2 weeks after recovery from COVID-19 infection. Symptoms improved after 5 months with a combination of hydroxyzine and cognitive behavioral therapy for insomnia (CBTi). Patient 2 developed insomnia at the same time as COVID-19 infection and symptoms consisted of sleep onset and maintenance insomnia.Hydroxyzine and trazodone were ineffective. Symptoms improved with zolpidem and CBTi. Patient 3 had a more severe course of COVID-19 infection requiring management in the intensive care unit that coincided with onset of insomnia. He presented to sleep clinic with new insomnia complaints but was also found to have moderate obstructive sleep apnea and periodic limb movements on polysomnography and prior history of restless legs. The patient was treated with a combination of positive airway pressure therapy and a dopamine agonist with plans to follow up to reassess severity of insomnia at future visit.

Conclusion
Three patients without a prior history of insomnia developed insomnia following infection with COVID-19. Management included a combination of CBTi and pharmacotherapy as well as treatment of underlying sleep disorders (OSA, RLS) when applicable. Further work is needed to understand the prevalence of new onset insomnia in patients following COVID-19 infection and best therapeutic approaches in this unique population.

Support (If Any)
0429 Insomnia vs Poor Sleep: Characteristics of Sleep Complaints in a Social Media Sample
Authors: Glidewell Robert , Okun Michele 
Published: May 2022

Abstract

Introduction
There is a tendency for individuals to interpret sleep difficulties as "poor sleep" rather than insomnia. This occurs even though when many individuals describe their symptoms, they often describe symptoms of insomnia. Indeed, they reject the label of insomnia as applying to their specific sleep difficulties. Misinterpreting chronic insomnia as simply "poor sleep" may prevent or delay treatment seeking behavior and thereby prolong/worsen associated negative outcomes. Little is known about the sleep characteristics and rate of chronic insomnia in individuals who interpret their sleep disturbance as “poor sleep.”

Methods
44,439 individuals age 30+ were shown an advertisement on social media with the prompt, "Poor sleep is annoying but insomnia is a serious issue. Take this free 1-minute quiz to learn the difference between insomnia and poor sleep." 1533 clicked on the ad to view the quiz and 468 completed the quiz. We included 449 responses in the current analysis. Nineteen were excluded as no insomnia symptoms were endorsed. The quiz queried DSM-V chronic insomnia diagnostic criteria. After completing the survey, the website supplied respondents with automated feedback and education about their responses.

Results
The quiz did not collect demographic information. However, those who clicked on the ad were 84% female and 87% age 55+. Sixty-nine percent (n=310) of responses met full diagnostic criteria. Reasons for not meeting diagnostic criteria were 13% (n=59) no sleep dissatisfaction, 10% (n=45) symptom frequency &lt;3 nights/week, 6% (n=25) symptom duration &lt;3 months, 7% (n=31) denied daytime symptoms, and 5% (n-21) inadequate opportunity for sleep. 54% (n=244) endorsed short sleep duration (&lt;6 hours) despite adequate opportunity for sleep.

Conclusion
Of community members responding to the advertisement, over 2/3 met full diagnostic criteria for chronic insomnia and over 50% appear to have the more severe phenotype of insomnia with short sleep duration. Formal study of subjective sleep disturbance interpretation may help develop effective methods for communicating with insomnia sufferers who may minimize or not recognize the seriousness of their sleep disturbance.

Support (If Any)
None
0434 The Relationship between Spirituality and Insomnia in Military Soldiers
Authors: Nunez-Cruz Nayeli , Miller Katherine , Brownlow Janeese , Klingaman Elizabeth , Gehrman Philip 
Published: May 2022

Abstract

Introduction
Insomnia is prevalent among military soldiers and contributes to poor physical and mental health outcomes. Spirituality has been found to mitigate mental and physical health complaints; however, there is a dearth of research on its relationship with insomnia, particularly among military soldiers. Therefore, this study examined the associations between spirituality, religiosity, and insomnia in a sample of Army soldiers.

Methods
Data were acquired from the All Army Study of the Army Study to Assess Risk and Resilience in Servicemembers (STARRS; N=21,449; mean age= 28.6; 88.24% male). Participants completed the Brief Insomnia Questionnaire, and current insomnia status was determined by DSM-5 criteria. They also completed questions on religious affiliation, how often they attend religious services, and how religious or spiritual they consider themselves on a 4-point scale (1-Very to 4-Not at all). Chi-Square analyses were used to assess the magnitude of relationships.

Results
A total of 19.45% of this sample had insomnia. Self-reported religious affiliation was more common in those without insomnia (73.5%) than those with insomnia (69.9%; p&lt;.0001). Self-reported spirituality and religiosity were associated with lower rates of insomnia (p&lt;.0001; p&lt;.0001). However, insomnia was associated with higher rates of regular attendance of religious services (29.8% vs. 26.0%; p&lt;.0001).

Conclusion
In this sample of Army servicemembers, insomnia was less prevalent among those with a religious affiliation and those with regular attendance at religious services. In contrast, individuals with insomnia reported themselves to be less religious or spiritual compared to those without insomnia. These findings underline the importance of further research to understand whether spirituality provides any protective effects against insomnia.

Support (If Any)
This publication is based on public use data from Army STARRS (Inter-university Consortium for Political and Social Research, University of Michigan-http://doi.org/10.3886/ICPSR35197-v1), funded by U.S. NIMH-U01MH087981. KEM’s time was supported by the U.S Department of Veterans Affairs, Veterans Health Administration (Clinical Science Research and Development Service – IK2 CX001874). EAK’s time was supported by the U.S Department of Veterans Affairs, Rehabilitation Research and Development Service – 1IK2 RX001836.
0435 The Relationship Between Pathogen Avoidance and Insomnia Symptoms: Results from a Longitudinal Study Conducted During the COVID-19 Pandemic
Authors: Walker Jamie , Makhanova Anastasia , Egeler Mara , Vargas Ivan 
Published: May 2022

Abstract

Introduction
Pathogen avoidance has intensified during the past two years because of fear related to the high transmissibility of SARS-CoV-2. This trend aligns with previous research that found increases in pathogen avoidance as a result of impaired immune system functioning, such as in the case of autoimmune disease. Another link to compromised immunity is the presence of insomnia symptoms, which may interfere with a healthy immune response to pathogens. It is not clear, however, if insomnia could be an immuno-compromising factor that leads to a compensatory increase in pathogen avoidance. Therefore, the purpose of the present study was to explore the relationship between situational pathogen avoidance and insomnia symptoms during the COVID-19 pandemic.

Methods
A national online survey was conducted at two time points: April-June 2020 (baseline) and January-March 2021 (follow-up). Insomnia symptoms were assessed using the Insomnia Severity Index (ISI). Affective, cognitive, and behavioral responses that comprise pathogen avoidance psychology, especially as it pertains to avoidance of potentially pathogenic social stimuli, were assessed with the Situational Pathogen Avoidance (SPA) scale.

Results
2,980 adults (mean age = 47 years) completed both surveys. Overall, the means on the SPA scale at both time points were higher than previously published norms (mean at both timepoints = 5.4), suggesting that average pathogen avoidance increased since the onset of the pandemic. The mean differences in the SPA scale varied by insomnia symptoms (at both time points), with participants who endorsed clinically elevated insomnia (ISI &gt;14) reporting higher pathogen avoidance (baseline, F(1,2972) =10.4, p = 0.001; follow-up, F(1,2918) =26.6, p &lt; 0.001).The mean differences in the SPA scale by insomnia were greater at follow-up compared to baseline (mean difference at baseline = 0.19; mean difference at follow-up = 0.33). This suggests that, compared to the initial months of the pandemic (Apr–June 2020), the relationship between insomnia and situational pathogen avoidance was stronger post-pandemic peak (Jan–Mar 2021).

Conclusion
Our findings suggest that there is a positive correlation between insomnia symptoms and situational pathogen avoidance. Furthermore, results indicated that this relationship became stronger as the pandemic went on.

Support (If Any)
K23HL141581 (PI: Vargas); R25HL10544 (PI: Jean-Louis); K24AG055602 (PI: Perlis)